New: Transoral Endocrine Surgery

About 250,000 thyroidectomies and parathyroidectomies are conducted yearly in the United States. The typical thyroid or parathyroid surgery is performed via the front of the neck. These operations are done mainly for thyroid enlargement, nodules, cancer, and parathyroid masses. Although conventional surgeries are effective and safe, they have one disadvantage in common: they leave an undesirable visible scar for many patients.

To avoid the neck scar, surgeons introduced the concept of transoral endocrine surgery (TES) in 2011. The first operation was performed in the United States, Apr 2016. Since then, more than 300 transoral operations have been conducted in the U.S. alone. The main surgical route was achieved via the upper lip, otherwise called the “endoscopic vestibular approach.”

To date experience has shown that the safety of TES is similar to the traditional operations for the following outcomes: recurrent laryngeal nerve injury, hypoparathyroidism, and rate of infections. Based on standard inclusion and exclusion criteria, authors have found that 56% of all patients undergoing thyroidectomy or parathyroidectomy are eligible for TES. 

The two most common conditions qualified for transoral endocrine surgery were thyroid nodules (76%) and parathyroid adenomas (58%). TES has the potential to be performed in the 100,000s of individuals annually. However, the authors’ findings need to be formally tested and validated before the mass application of the operation.

GT

TES exclusion criteria:

  • Any patient who met 1 or more of these exclusion criteria was deemed ineligible for TES. After applying the exclusion criteria, the cases were then tabulated to determine the percent eligible rate.

The 3 institutions represented both general surgery (2 institutions) and otolaryngology–head and neck surgery–trained disciplines (1 institution), and substantial variations in disease presentation are represented among the practices. Given this variation and representation of both subspecialties, we believe these data are broadly applicable to all patients undergoing thyroid and parathyroid operations in academic medical centers.

It is estimated that 150 ,000 thyroidectomies and 100, 000 parathyroidectomies are performed annually in the United States. Applying a 56% eligibility shows that it is possible that as many as 140 ,000 patients per year in the United States could be eligible for TES. Considering that up to 140 ,000 thyroid and parathyroid operations could be performed via TES annually in the United States, our results suggest that TES is applicable to a large number of patients and may not be considered a “boutique” operation in the near future.

The adoption and expansion of TES depend on several factors. First and foremost, it must be proven to be at least as safe as the open surgical approach and to have equivalent outcomes. The case series by Anuwong and colleagues is helpful in this regard and clearly demonstrates that infection is not an issue in the hands of experienced surgeons.

In 425 procedures, there were no infections. This is clear evidence that infection rates are not as concerning as initially feared and is consistent with the anecdotal experience of the authors. However, the case series by Anuwong and colleagues remains that of a single institution; thus, it remains unclear whether the low rate of infection, recurrent laryngeal nerve injury, and hypoparathyroidism rates can be replicated by other surgeons.

Early reports from the United States are promising, however. In addition, the incidence of other technique-specific complications remains unknown. The only way to prove that other surgeons can in fact replicate the success shown in the study by Anuwong et al is with a multicenter, multi-surgeon trial. While these data are accumulating, training and adoption of the new technique should be done in a safe and thoughtful manner. 

Second, it must be demonstrated whether the absence of a cutaneous incision either improves quality of life or adds value for patients. Again, data are limited in this regard. Given that the present study shows that hundreds of thousands of patients with thyroid and parathyroid disease could be treated with TES in the United States, we believe our findings strongly support the need for definitive studies on safety and efficacy. Other questions regarding the procedure, such as cost, physician perceptions, and patient-centered outcomes, could also be answered by a trial.

Although incision size is not the only criterion that classifies an operation as minimally invasive, some consider the traditional approach to focused parathyroidectomies to already be minimally invasive, if it is performed with a 2-cm incision. If that is the case, the merits of moving that 2-cm incision from the neck to the inside of the lower lip may be questioned by some. However, it is not clear how many surgeons actually perform a “minimally invasive” parathyroidectomy via a 2-cm incision. In addition, recent advances in TES parathyroidectomy have reduced the total incision size to 1 cm in select cases through the use of pediatric laparoscopic trocars. If the operation is as safe as the traditional approach, we believe the preference of avoiding a cervical scar should be left to individual patients as long as they are eligible for TES. The patient’s autonomy in choosing TES is especially relevant because it has been demonstrated that patients are concerned about cervical scars no matter how well they heal or how small they are. However, even if the parathyroidectomies are removed from the indications for TES in this population, there are still more than 80 000 patients undergoing thyroidectomies done each year in the United States who are potentially eligible for this scarless technique, thus justifying further exploration of this approach.

As stated, the value of not having a scar on the neck has been questioned. However, data continue to accumulate showing that scars, particularly in very prominent locations such as the front of the neck, are bothersome to some people, and if given a choice many would prefer to not have that scar visible. Previous US studies have concluded that more than 10% of patients undergoing thyroidectomy consider a scar revision even years after surgery, and that 50% of patients are “extremely satisfied” with their scar. 

Preliminary data from Johns Hopkins University have shown that there is a penalty in overall attractiveness for patients with a Kocher incision, and that patients would be willing to pay more than $10 000 to avoid this incision. In that same study, the authors demonstrated that, in patients who underwent a TES procedure, there was no attractiveness penalty. Although the value of avoiding a cervical incision remains to be fully studied, it is apparent that at least some patients or potential patients prefer to avoid a cervical incision, even if there is additional surgical risk or cost.

Our data demonstrated that TES was applicable to more than half of all open thyroid and parathyroid surgery candidates in academic practices included in this study when standard inclusion and exclusion criteria were applied. Results of this study suggest that there are potentially hundreds of thousands of patients who may be eligible to forego a cutaneous incision. We believe these data show that TES is not and should not be considered an operation with limited applicability. Transoral endocrine surgery has the potential to improve the lives of a large number of patients, and thus it should be considered a viable option in the United States.

Based on these data, a large, prospective multicenter trial is warranted to further evaluate the safety, clinical outcomes, patient-centered outcomes, and costs of TES.

  • Previous neck operation 97 of 441 (22.0%),
  • Non-localized primary hyperparathyroidism 78 of 441 (17.7%)
  • Need for neck dissection 66 of 441 (15.0%).

Conclusion

More than half of all patients undergoing thyroid and parathyroid surgery in this study were eligible for TES. This broad applicability suggests that a prospective multicenter trial is reasonable to definitively study the safety, outcomes, and cost of TES.

Transoral+endocrine+surgery

More from the publication

Transoral endocrine surgery (TES) comprises a group of operations that allow thyroidectomies and parathyroidectomies to be done without leaving a visible scar on the patient’s neck. As the name implies, access to the neck is via the oral cavity. Currently, the main advantage of these operations is the lack of a visible scar in an area that is not easily hidden. The most common TES techniques currently used in the United States are TOETVA (transoral endoscopic thyroidectomy vestibular approach) for thyroidectomy and TOEPVA (transoral endoscopic parathyroidectomy vestibular approach) for parathyroidectomy.

The transoral vestibular approach was first described in 2011 in cadavers by Richmon et al and later popularized by Anuwong in humans. This approach has supplanted all other oral access approaches to the thyroid and parathyroid because of its improved safety and feasibility; thus, TES may also be referred to as TOVAES (transoral vestibular approach endocrine surgery).

Proponents of TES cite the proximity to the target anatomy as one of the main advantages of these operations over other minimally invasive or remote-access approaches to the neck. In addition, because the aggregate length of these incisions is typically 2 cm or less, TES could be considered a minimally invasive procedure for thyroidectomy, and either a minimally invasive or a remote-access procedure for parathyroidectomy.

The first endoscopic and robotic TES operations were performed in the United States in April 2016.

It is estimated that as of January 2019 approximately 300 of these procedures have been performed in the United States, across multiple centers.

A series of 425 cases by Anuwong et al is the largest series of TES cases published to date. In this series, TES outcomes were compared with equivalent open procedures using propensity score matching. The authors concluded that the TES approach was equivalent to open technique in terms of safety, with similar rates of recurrent laryngeal nerve injury and hypoparathyroidism. In addition, no wound infections and no additional permanent complications were associated with this approach.

In spite of these published data, there remains significant skepticism in the United States in regard to safety and outcomes. In addition, there has been debate regarding how widely applicable these procedures are in the general population, with some authors suggesting that only a very small portion of thyroid and parathyroid operations can be done using these techniques. 

Given the above information, we set out to better understand how broad or narrow the scope of TES is in the United States. We retrospectively reviewed a consecutive series of 1000 surgical cases from 3 different academic endocrine surgery practices in the United States. We then applied a standard set of TES inclusion and exclusion criteria to these cases to determine how many patients who presented for an operation would have been eligible for these procedures in an US academic thyroid and parathyroid surgery practice.

Herein for the first time, to our knowledge, we demonstrate the potential, based on our results, that 55.8% (range, 50.8%-65.5%) of patients who present to an academic thyroid and parathyroid surgery practice in the United States are eligible for TES.

To determine how many cases would have been eligible for TES, we applied a standard set of exclusion criteria as previously described in the literature. These exclusion criteria were:

  • Serious medical comorbidity that would contraindicate a prolonged procedure time
  • Previous external beam radiation to the neck
  • Previous open neck operation
  • Benign single nodule >6 cm
  • Malignant thyroid tumor >2 cm
  • Total thyroid lobe diameter >10 cm
  • Substernal thyroid
  • Indications for a therapeutic central neck dissection
  • Indications for a lateral neck dissection
  • Non-localized primary hyperparathyroidism
  • Secondary hyperparathyroidism
  • Tertiary hyperparathyroidism.

    • Any patient who met 1 or more of these exclusion criteria was deemed ineligible for TES. After applying the exclusion criteria, the cases were then tabulated to determine the percent eligible rate.

The 3 institutions represented both general surgery (2 institutions) and otolaryngology–head and neck surgery–trained disciplines (1 institution), and substantial variations in disease presentation are represented among the practices. Given this variation and representation of both subspecialties, we believe these data are broadly applicable to all patients undergoing thyroid and parathyroid operations in academic medical centers.

It is estimated that 150 ,000 thyroidectomies and 100, 000 parathyroidectomies are performed annually in the United States. Applying a 56% eligibility shows that it is possible that as many as 140 ,000 patients per year in the United States could be eligible for TES. Considering that up to 140 ,000 thyroid and parathyroid operations could be performed via TES annually in the United States, our results suggest that TES is applicable to a large number of patients and may not be considered a “boutique” operation in the near future.

The adoption and expansion of TES depend on several factors. First and foremost, it must be proven to be at least as safe as the open surgical approach and to have equivalent outcomes. The case series by Anuwong and colleagues is helpful in this regard and clearly demonstrates that infection is not an issue in the hands of experienced surgeons.

In 425 procedures, there were no infections. This is clear evidence that infection rates are not as concerning as initially feared and is consistent with the anecdotal experience of the authors. However, the case series by Anuwong and colleagues remains that of a single institution; thus, it remains unclear whether the low rate of infection, recurrent laryngeal nerve injury, and hypoparathyroidism rates can be replicated by other surgeons.

Early reports from the United States are promising, however. In addition, the incidence of other technique-specific complications remains unknown. The only way to prove that other surgeons can in fact replicate the success shown in the study by Anuwong et al is with a multicenter, multi-surgeon trial. While these data are accumulating, training and adoption of the new technique should be done in a safe and thoughtful manner. 

Second, it must be demonstrated whether the absence of a cutaneous incision either improves quality of life or adds value for patients. Again, data are limited in this regard. Given that the present study shows that hundreds of thousands of patients with thyroid and parathyroid disease could be treated with TES in the United States, we believe our findings strongly support the need for definitive studies on safety and efficacy. Other questions regarding the procedure, such as cost, physician perceptions, and patient-centered outcomes, could also be answered by a trial.

Although incision size is not the only criterion that classifies an operation as minimally invasive, some consider the traditional approach to focused parathyroidectomies to already be minimally invasive, if it is performed with a 2-cm incision. If that is the case, the merits of moving that 2-cm incision from the neck to the inside of the lower lip may be questioned by some. However, it is not clear how many surgeons actually perform a “minimally invasive” parathyroidectomy via a 2-cm incision. In addition, recent advances in TES parathyroidectomy have reduced the total incision size to 1 cm in select cases through the use of pediatric laparoscopic trocars. If the operation is as safe as the traditional approach, we believe the preference of avoiding a cervical scar should be left to individual patients as long as they are eligible for TES. The patient’s autonomy in choosing TES is especially relevant because it has been demonstrated that patients are concerned about cervical scars no matter how well they heal or how small they are. However, even if the parathyroidectomies are removed from the indications for TES in this population, there are still more than 80 000 patients undergoing thyroidectomies done each year in the United States who are potentially eligible for this scarless technique, thus justifying further exploration of this approach.

As stated, the value of not having a scar on the neck has been questioned. However, data continue to accumulate showing that scars, particularly in very prominent locations such as the front of the neck, are bothersome to some people, and if given a choice many would prefer to not have that scar visible. Previous US studies have concluded that more than 10% of patients undergoing thyroidectomy consider a scar revision even years after surgery, and that 50% of patients are “extremely satisfied” with their scar. 

Preliminary data from Johns Hopkins University have shown that there is a penalty in overall attractiveness for patients with a Kocher incision, and that patients would be willing to pay more than $10 000 to avoid this incision. In that same study, the authors demonstrated that, in patients who underwent a TES procedure, there was no attractiveness penalty. Although the value of avoiding a cervical incision remains to be fully studied, it is apparent that at least some patients or potential patients prefer to avoid a cervical incision, even if there is additional surgical risk or cost.

Our data demonstrated that TES was applicable to more than half of all open thyroid and parathyroid surgery candidates in academic practices included in this study when standard inclusion and exclusion criteria were applied. Results of this study suggest that there are potentially hundreds of thousands of patients who may be eligible to forego a cutaneous incision. We believe these data show that TES is not and should not be considered an operation with limited applicability. Transoral endocrine surgery has the potential to improve the lives of a large number of patients, and thus it should be considered a viable option in the United States.

Based on these data, a large, prospective multicenter trial is warranted to further evaluate the safety, clinical outcomes, patient-centered outcomes, and costs of TES.

  • Most patients with thyroid nodules with cytologically indeterminate behavior 165 of 217, 76.0%)
  • Benign thyroid conditions 166 of 240 (69.2%)
  • Primary hyperparathyroidism 158 of 273 (57.9%)
  • Thyroid cancer 67 of 231 (29.0%)

Among all 1000 cases reviewed, most common reasons for ineligibility were:

  • Previous neck operation 97 of 441 (22.0%),
  • Non-localized primary hyperparathyroidism 78 of 441 (17.7%)
  • Need for neck dissection 66 of 441 (15.0%).

Conclusion

More than half of all patients undergoing thyroid and parathyroid surgery in this study were eligible for TES. This broad applicability suggests that a prospective multicenter trial is reasonable to definitively study the safety, outcomes, and cost of TES.

Transoral+endocrine+surgery

More from the publication

Transoral endocrine surgery (TES) comprises a group of operations that allow thyroidectomies and parathyroidectomies to be done without leaving a visible scar on the patient’s neck. As the name implies, access to the neck is via the oral cavity. Currently, the main advantage of these operations is the lack of a visible scar in an area that is not easily hidden. The most common TES techniques currently used in the United States are TOETVA (transoral endoscopic thyroidectomy vestibular approach) for thyroidectomy and TOEPVA (transoral endoscopic parathyroidectomy vestibular approach) for parathyroidectomy.

The transoral vestibular approach was first described in 2011 in cadavers by Richmon et al and later popularized by Anuwong in humans. This approach has supplanted all other oral access approaches to the thyroid and parathyroid because of its improved safety and feasibility; thus, TES may also be referred to as TOVAES (transoral vestibular approach endocrine surgery).

Proponents of TES cite the proximity to the target anatomy as one of the main advantages of these operations over other minimally invasive or remote-access approaches to the neck. In addition, because the aggregate length of these incisions is typically 2 cm or less, TES could be considered a minimally invasive procedure for thyroidectomy, and either a minimally invasive or a remote-access procedure for parathyroidectomy.

The first endoscopic and robotic TES operations were performed in the United States in April 2016.

It is estimated that as of January 2019 approximately 300 of these procedures have been performed in the United States, across multiple centers.

A series of 425 cases by Anuwong et al is the largest series of TES cases published to date. In this series, TES outcomes were compared with equivalent open procedures using propensity score matching. The authors concluded that the TES approach was equivalent to open technique in terms of safety, with similar rates of recurrent laryngeal nerve injury and hypoparathyroidism. In addition, no wound infections and no additional permanent complications were associated with this approach.

In spite of these published data, there remains significant skepticism in the United States in regard to safety and outcomes. In addition, there has been debate regarding how widely applicable these procedures are in the general population, with some authors suggesting that only a very small portion of thyroid and parathyroid operations can be done using these techniques. 

Given the above information, we set out to better understand how broad or narrow the scope of TES is in the United States. We retrospectively reviewed a consecutive series of 1000 surgical cases from 3 different academic endocrine surgery practices in the United States. We then applied a standard set of TES inclusion and exclusion criteria to these cases to determine how many patients who presented for an operation would have been eligible for these procedures in an US academic thyroid and parathyroid surgery practice.

Herein for the first time, to our knowledge, we demonstrate the potential, based on our results, that 55.8% (range, 50.8%-65.5%) of patients who present to an academic thyroid and parathyroid surgery practice in the United States are eligible for TES.

To determine how many cases would have been eligible for TES, we applied a standard set of exclusion criteria as previously described in the literature. These exclusion criteria were:

  • Serious medical comorbidity that would contraindicate a prolonged procedure time
  • Previous external beam radiation to the neck
  • Previous open neck operation
  • Benign single nodule >6 cm
  • Malignant thyroid tumor >2 cm
  • Total thyroid lobe diameter >10 cm
  • Substernal thyroid
  • Indications for a therapeutic central neck dissection
  • Indications for a lateral neck dissection
  • Non-localized primary hyperparathyroidism
  • Secondary hyperparathyroidism
  • Tertiary hyperparathyroidism.

    • Any patient who met 1 or more of these exclusion criteria was deemed ineligible for TES. After applying the exclusion criteria, the cases were then tabulated to determine the percent eligible rate.

The 3 institutions represented both general surgery (2 institutions) and otolaryngology–head and neck surgery–trained disciplines (1 institution), and substantial variations in disease presentation are represented among the practices. Given this variation and representation of both subspecialties, we believe these data are broadly applicable to all patients undergoing thyroid and parathyroid operations in academic medical centers.

It is estimated that 150 ,000 thyroidectomies and 100, 000 parathyroidectomies are performed annually in the United States. Applying a 56% eligibility shows that it is possible that as many as 140 ,000 patients per year in the United States could be eligible for TES. Considering that up to 140 ,000 thyroid and parathyroid operations could be performed via TES annually in the United States, our results suggest that TES is applicable to a large number of patients and may not be considered a “boutique” operation in the near future.

The adoption and expansion of TES depend on several factors. First and foremost, it must be proven to be at least as safe as the open surgical approach and to have equivalent outcomes. The case series by Anuwong and colleagues is helpful in this regard and clearly demonstrates that infection is not an issue in the hands of experienced surgeons.

In 425 procedures, there were no infections. This is clear evidence that infection rates are not as concerning as initially feared and is consistent with the anecdotal experience of the authors. However, the case series by Anuwong and colleagues remains that of a single institution; thus, it remains unclear whether the low rate of infection, recurrent laryngeal nerve injury, and hypoparathyroidism rates can be replicated by other surgeons.

Early reports from the United States are promising, however. In addition, the incidence of other technique-specific complications remains unknown. The only way to prove that other surgeons can in fact replicate the success shown in the study by Anuwong et al is with a multicenter, multi-surgeon trial. While these data are accumulating, training and adoption of the new technique should be done in a safe and thoughtful manner. 

Second, it must be demonstrated whether the absence of a cutaneous incision either improves quality of life or adds value for patients. Again, data are limited in this regard. Given that the present study shows that hundreds of thousands of patients with thyroid and parathyroid disease could be treated with TES in the United States, we believe our findings strongly support the need for definitive studies on safety and efficacy. Other questions regarding the procedure, such as cost, physician perceptions, and patient-centered outcomes, could also be answered by a trial.

Although incision size is not the only criterion that classifies an operation as minimally invasive, some consider the traditional approach to focused parathyroidectomies to already be minimally invasive, if it is performed with a 2-cm incision. If that is the case, the merits of moving that 2-cm incision from the neck to the inside of the lower lip may be questioned by some. However, it is not clear how many surgeons actually perform a “minimally invasive” parathyroidectomy via a 2-cm incision. In addition, recent advances in TES parathyroidectomy have reduced the total incision size to 1 cm in select cases through the use of pediatric laparoscopic trocars. If the operation is as safe as the traditional approach, we believe the preference of avoiding a cervical scar should be left to individual patients as long as they are eligible for TES. The patient’s autonomy in choosing TES is especially relevant because it has been demonstrated that patients are concerned about cervical scars no matter how well they heal or how small they are. However, even if the parathyroidectomies are removed from the indications for TES in this population, there are still more than 80 000 patients undergoing thyroidectomies done each year in the United States who are potentially eligible for this scarless technique, thus justifying further exploration of this approach.

As stated, the value of not having a scar on the neck has been questioned. However, data continue to accumulate showing that scars, particularly in very prominent locations such as the front of the neck, are bothersome to some people, and if given a choice many would prefer to not have that scar visible. Previous US studies have concluded that more than 10% of patients undergoing thyroidectomy consider a scar revision even years after surgery, and that 50% of patients are “extremely satisfied” with their scar. 

Preliminary data from Johns Hopkins University have shown that there is a penalty in overall attractiveness for patients with a Kocher incision, and that patients would be willing to pay more than $10 000 to avoid this incision. In that same study, the authors demonstrated that, in patients who underwent a TES procedure, there was no attractiveness penalty. Although the value of avoiding a cervical incision remains to be fully studied, it is apparent that at least some patients or potential patients prefer to avoid a cervical incision, even if there is additional surgical risk or cost.

Our data demonstrated that TES was applicable to more than half of all open thyroid and parathyroid surgery candidates in academic practices included in this study when standard inclusion and exclusion criteria were applied. Results of this study suggest that there are potentially hundreds of thousands of patients who may be eligible to forego a cutaneous incision. We believe these data show that TES is not and should not be considered an operation with limited applicability. Transoral endocrine surgery has the potential to improve the lives of a large number of patients, and thus it should be considered a viable option in the United States.

Based on these data, a large, prospective multicenter trial is warranted to further evaluate the safety, clinical outcomes, patient-centered outcomes, and costs of TES.

  • Primary outcome was the percentage of thyroid and parathyroid cases eligible for TES.
  • Secondary outcomes were a subgroup analysis of the percentage of specific types of cases eligible and the reasons for ineligibility.

Results

The mean age of the 1000 surgical patients was 53 years, mean BMI was 29, and 747 (75.0%) of the patients were women. 56% of the patients were eligible for TES.

The following patients were eligible for TES:

  • Most patients with thyroid nodules with cytologically indeterminate behavior 165 of 217, 76.0%)
  • Benign thyroid conditions 166 of 240 (69.2%)
  • Primary hyperparathyroidism 158 of 273 (57.9%)
  • Thyroid cancer 67 of 231 (29.0%)

Among all 1000 cases reviewed, most common reasons for ineligibility were:

  • Previous neck operation 97 of 441 (22.0%),
  • Non-localized primary hyperparathyroidism 78 of 441 (17.7%)
  • Need for neck dissection 66 of 441 (15.0%).

Conclusion

More than half of all patients undergoing thyroid and parathyroid surgery in this study were eligible for TES. This broad applicability suggests that a prospective multicenter trial is reasonable to definitively study the safety, outcomes, and cost of TES.

Transoral+endocrine+surgery

More from the publication

Transoral endocrine surgery (TES) comprises a group of operations that allow thyroidectomies and parathyroidectomies to be done without leaving a visible scar on the patient’s neck. As the name implies, access to the neck is via the oral cavity. Currently, the main advantage of these operations is the lack of a visible scar in an area that is not easily hidden. The most common TES techniques currently used in the United States are TOETVA (transoral endoscopic thyroidectomy vestibular approach) for thyroidectomy and TOEPVA (transoral endoscopic parathyroidectomy vestibular approach) for parathyroidectomy.

The transoral vestibular approach was first described in 2011 in cadavers by Richmon et al and later popularized by Anuwong in humans. This approach has supplanted all other oral access approaches to the thyroid and parathyroid because of its improved safety and feasibility; thus, TES may also be referred to as TOVAES (transoral vestibular approach endocrine surgery).

Proponents of TES cite the proximity to the target anatomy as one of the main advantages of these operations over other minimally invasive or remote-access approaches to the neck. In addition, because the aggregate length of these incisions is typically 2 cm or less, TES could be considered a minimally invasive procedure for thyroidectomy, and either a minimally invasive or a remote-access procedure for parathyroidectomy.

The first endoscopic and robotic TES operations were performed in the United States in April 2016.

It is estimated that as of January 2019 approximately 300 of these procedures have been performed in the United States, across multiple centers.

A series of 425 cases by Anuwong et al is the largest series of TES cases published to date. In this series, TES outcomes were compared with equivalent open procedures using propensity score matching. The authors concluded that the TES approach was equivalent to open technique in terms of safety, with similar rates of recurrent laryngeal nerve injury and hypoparathyroidism. In addition, no wound infections and no additional permanent complications were associated with this approach.

In spite of these published data, there remains significant skepticism in the United States in regard to safety and outcomes. In addition, there has been debate regarding how widely applicable these procedures are in the general population, with some authors suggesting that only a very small portion of thyroid and parathyroid operations can be done using these techniques. 

Given the above information, we set out to better understand how broad or narrow the scope of TES is in the United States. We retrospectively reviewed a consecutive series of 1000 surgical cases from 3 different academic endocrine surgery practices in the United States. We then applied a standard set of TES inclusion and exclusion criteria to these cases to determine how many patients who presented for an operation would have been eligible for these procedures in an US academic thyroid and parathyroid surgery practice.

Herein for the first time, to our knowledge, we demonstrate the potential, based on our results, that 55.8% (range, 50.8%-65.5%) of patients who present to an academic thyroid and parathyroid surgery practice in the United States are eligible for TES.

To determine how many cases would have been eligible for TES, we applied a standard set of exclusion criteria as previously described in the literature. These exclusion criteria were:

  • Serious medical comorbidity that would contraindicate a prolonged procedure time
  • Previous external beam radiation to the neck
  • Previous open neck operation
  • Benign single nodule >6 cm
  • Malignant thyroid tumor >2 cm
  • Total thyroid lobe diameter >10 cm
  • Substernal thyroid
  • Indications for a therapeutic central neck dissection
  • Indications for a lateral neck dissection
  • Non-localized primary hyperparathyroidism
  • Secondary hyperparathyroidism
  • Tertiary hyperparathyroidism.

    • Any patient who met 1 or more of these exclusion criteria was deemed ineligible for TES. After applying the exclusion criteria, the cases were then tabulated to determine the percent eligible rate.

The 3 institutions represented both general surgery (2 institutions) and otolaryngology–head and neck surgery–trained disciplines (1 institution), and substantial variations in disease presentation are represented among the practices. Given this variation and representation of both subspecialties, we believe these data are broadly applicable to all patients undergoing thyroid and parathyroid operations in academic medical centers.

It is estimated that 150 ,000 thyroidectomies and 100, 000 parathyroidectomies are performed annually in the United States. Applying a 56% eligibility shows that it is possible that as many as 140 ,000 patients per year in the United States could be eligible for TES. Considering that up to 140 ,000 thyroid and parathyroid operations could be performed via TES annually in the United States, our results suggest that TES is applicable to a large number of patients and may not be considered a “boutique” operation in the near future.

The adoption and expansion of TES depend on several factors. First and foremost, it must be proven to be at least as safe as the open surgical approach and to have equivalent outcomes. The case series by Anuwong and colleagues is helpful in this regard and clearly demonstrates that infection is not an issue in the hands of experienced surgeons.

In 425 procedures, there were no infections. This is clear evidence that infection rates are not as concerning as initially feared and is consistent with the anecdotal experience of the authors. However, the case series by Anuwong and colleagues remains that of a single institution; thus, it remains unclear whether the low rate of infection, recurrent laryngeal nerve injury, and hypoparathyroidism rates can be replicated by other surgeons.

Early reports from the United States are promising, however. In addition, the incidence of other technique-specific complications remains unknown. The only way to prove that other surgeons can in fact replicate the success shown in the study by Anuwong et al is with a multicenter, multi-surgeon trial. While these data are accumulating, training and adoption of the new technique should be done in a safe and thoughtful manner. 

Second, it must be demonstrated whether the absence of a cutaneous incision either improves quality of life or adds value for patients. Again, data are limited in this regard. Given that the present study shows that hundreds of thousands of patients with thyroid and parathyroid disease could be treated with TES in the United States, we believe our findings strongly support the need for definitive studies on safety and efficacy. Other questions regarding the procedure, such as cost, physician perceptions, and patient-centered outcomes, could also be answered by a trial.

Although incision size is not the only criterion that classifies an operation as minimally invasive, some consider the traditional approach to focused parathyroidectomies to already be minimally invasive, if it is performed with a 2-cm incision. If that is the case, the merits of moving that 2-cm incision from the neck to the inside of the lower lip may be questioned by some. However, it is not clear how many surgeons actually perform a “minimally invasive” parathyroidectomy via a 2-cm incision. In addition, recent advances in TES parathyroidectomy have reduced the total incision size to 1 cm in select cases through the use of pediatric laparoscopic trocars. If the operation is as safe as the traditional approach, we believe the preference of avoiding a cervical scar should be left to individual patients as long as they are eligible for TES. The patient’s autonomy in choosing TES is especially relevant because it has been demonstrated that patients are concerned about cervical scars no matter how well they heal or how small they are. However, even if the parathyroidectomies are removed from the indications for TES in this population, there are still more than 80 000 patients undergoing thyroidectomies done each year in the United States who are potentially eligible for this scarless technique, thus justifying further exploration of this approach.

As stated, the value of not having a scar on the neck has been questioned. However, data continue to accumulate showing that scars, particularly in very prominent locations such as the front of the neck, are bothersome to some people, and if given a choice many would prefer to not have that scar visible. Previous US studies have concluded that more than 10% of patients undergoing thyroidectomy consider a scar revision even years after surgery, and that 50% of patients are “extremely satisfied” with their scar. 

Preliminary data from Johns Hopkins University have shown that there is a penalty in overall attractiveness for patients with a Kocher incision, and that patients would be willing to pay more than $10 000 to avoid this incision. In that same study, the authors demonstrated that, in patients who underwent a TES procedure, there was no attractiveness penalty. Although the value of avoiding a cervical incision remains to be fully studied, it is apparent that at least some patients or potential patients prefer to avoid a cervical incision, even if there is additional surgical risk or cost.

Our data demonstrated that TES was applicable to more than half of all open thyroid and parathyroid surgery candidates in academic practices included in this study when standard inclusion and exclusion criteria were applied. Results of this study suggest that there are potentially hundreds of thousands of patients who may be eligible to forego a cutaneous incision. We believe these data show that TES is not and should not be considered an operation with limited applicability. Transoral endocrine surgery has the potential to improve the lives of a large number of patients, and thus it should be considered a viable option in the United States.

Based on these data, a large, prospective multicenter trial is warranted to further evaluate the safety, clinical outcomes, patient-centered outcomes, and costs of TES.

  • Serious medical comorbidity that would contraindicate a prolonged procedure time
  • Previous external beam radiation to the neck
  • Previous open neck operation
  • Benign single nodule >6 cm
  • Malignant thyroid tumor >2 cm
  • Total thyroid lobe diameter >10 cm
  • Substernal thyroid
  • Indications for a therapeutic central neck dissection
  • Indications for a therapeutic lateral neck dissection
  • Non-localized primary hyperparathyroidism
  • Secondary hyperparathyroidism
  • Tertiary hyperparathyroidism.

Also see:

Thyroid cancer

Thyroid nodule

Thyroid surgery

Transoral endoscopic thyroidectomy

J A M A

Cross Sectional

May 2019

Importance 

Transoral endocrine surgery (TES) allows thyroid and parathyroid operations to be performed without leaving any visible scar on the body. Controversy regarding the value of TES remains, in part owing to the common belief that TES is only applicable to a small, select group of patients. Knowledge of the overall applicability of these procedures is essential to understand the operation, as well as to decide the amount of effort and resources that should be allocated to further study the safety, efficacy, and value of these operations.

Objective

To determine what percentage of US patients undergoing thyroid and parathyroid surgery are eligible for TES using currently accepted exclusion criteria.

Design

Cross-sectional study of 1000 consecutive thyroid and parathyroid operations (with or without neck dissection) performed between July 1, 2015 – July 1, 2018, at 3 high-volume academic US thyroid- and parathyroid-focused surgical practices (2 general surgery, 1 otolaryngology–head and neck endocrine surgery). Eligibility for TES was determined by retrospectively applying previously published exclusion criteria to the cases.

Main Outcomes

  • Primary outcome was the percentage of thyroid and parathyroid cases eligible for TES.
  • Secondary outcomes were a subgroup analysis of the percentage of specific types of cases eligible and the reasons for ineligibility.

Results

The mean age of the 1000 surgical patients was 53 years, mean BMI was 29, and 747 (75.0%) of the patients were women. 56% of the patients were eligible for TES.

The following patients were eligible for TES:

  • Most patients with thyroid nodules with cytologically indeterminate behavior 165 of 217, 76.0%)
  • Benign thyroid conditions 166 of 240 (69.2%)
  • Primary hyperparathyroidism 158 of 273 (57.9%)
  • Thyroid cancer 67 of 231 (29.0%)

Among all 1000 cases reviewed, most common reasons for ineligibility were:

  • Previous neck operation 97 of 441 (22.0%),
  • Non-localized primary hyperparathyroidism 78 of 441 (17.7%)
  • Need for neck dissection 66 of 441 (15.0%).

Conclusion

More than half of all patients undergoing thyroid and parathyroid surgery in this study were eligible for TES. This broad applicability suggests that a prospective multicenter trial is reasonable to definitively study the safety, outcomes, and cost of TES.

Transoral+endocrine+surgery

More from the publication

Transoral endocrine surgery (TES) comprises a group of operations that allow thyroidectomies and parathyroidectomies to be done without leaving a visible scar on the patient’s neck. As the name implies, access to the neck is via the oral cavity. Currently, the main advantage of these operations is the lack of a visible scar in an area that is not easily hidden. The most common TES techniques currently used in the United States are TOETVA (transoral endoscopic thyroidectomy vestibular approach) for thyroidectomy and TOEPVA (transoral endoscopic parathyroidectomy vestibular approach) for parathyroidectomy.

The transoral vestibular approach was first described in 2011 in cadavers by Richmon et al and later popularized by Anuwong in humans. This approach has supplanted all other oral access approaches to the thyroid and parathyroid because of its improved safety and feasibility; thus, TES may also be referred to as TOVAES (transoral vestibular approach endocrine surgery).

Proponents of TES cite the proximity to the target anatomy as one of the main advantages of these operations over other minimally invasive or remote-access approaches to the neck. In addition, because the aggregate length of these incisions is typically 2 cm or less, TES could be considered a minimally invasive procedure for thyroidectomy, and either a minimally invasive or a remote-access procedure for parathyroidectomy.

The first endoscopic and robotic TES operations were performed in the United States in April 2016.

It is estimated that as of January 2019 approximately 300 of these procedures have been performed in the United States, across multiple centers.

A series of 425 cases by Anuwong et al is the largest series of TES cases published to date. In this series, TES outcomes were compared with equivalent open procedures using propensity score matching. The authors concluded that the TES approach was equivalent to open technique in terms of safety, with similar rates of recurrent laryngeal nerve injury and hypoparathyroidism. In addition, no wound infections and no additional permanent complications were associated with this approach.

In spite of these published data, there remains significant skepticism in the United States in regard to safety and outcomes. In addition, there has been debate regarding how widely applicable these procedures are in the general population, with some authors suggesting that only a very small portion of thyroid and parathyroid operations can be done using these techniques. 

Given the above information, we set out to better understand how broad or narrow the scope of TES is in the United States. We retrospectively reviewed a consecutive series of 1000 surgical cases from 3 different academic endocrine surgery practices in the United States. We then applied a standard set of TES inclusion and exclusion criteria to these cases to determine how many patients who presented for an operation would have been eligible for these procedures in an US academic thyroid and parathyroid surgery practice.

Herein for the first time, to our knowledge, we demonstrate the potential, based on our results, that 55.8% (range, 50.8%-65.5%) of patients who present to an academic thyroid and parathyroid surgery practice in the United States are eligible for TES.

To determine how many cases would have been eligible for TES, we applied a standard set of exclusion criteria as previously described in the literature. These exclusion criteria were:

  • Serious medical comorbidity that would contraindicate a prolonged procedure time
  • Previous external beam radiation to the neck
  • Previous open neck operation
  • Benign single nodule >6 cm
  • Malignant thyroid tumor >2 cm
  • Total thyroid lobe diameter >10 cm
  • Substernal thyroid
  • Indications for a therapeutic central neck dissection
  • Indications for a lateral neck dissection
  • Non-localized primary hyperparathyroidism
  • Secondary hyperparathyroidism
  • Tertiary hyperparathyroidism.

    • Any patient who met 1 or more of these exclusion criteria was deemed ineligible for TES. After applying the exclusion criteria, the cases were then tabulated to determine the percent eligible rate.

The 3 institutions represented both general surgery (2 institutions) and otolaryngology–head and neck surgery–trained disciplines (1 institution), and substantial variations in disease presentation are represented among the practices. Given this variation and representation of both subspecialties, we believe these data are broadly applicable to all patients undergoing thyroid and parathyroid operations in academic medical centers.

It is estimated that 150 ,000 thyroidectomies and 100, 000 parathyroidectomies are performed annually in the United States. Applying a 56% eligibility shows that it is possible that as many as 140 ,000 patients per year in the United States could be eligible for TES. Considering that up to 140 ,000 thyroid and parathyroid operations could be performed via TES annually in the United States, our results suggest that TES is applicable to a large number of patients and may not be considered a “boutique” operation in the near future.

The adoption and expansion of TES depend on several factors. First and foremost, it must be proven to be at least as safe as the open surgical approach and to have equivalent outcomes. The case series by Anuwong and colleagues is helpful in this regard and clearly demonstrates that infection is not an issue in the hands of experienced surgeons.

In 425 procedures, there were no infections. This is clear evidence that infection rates are not as concerning as initially feared and is consistent with the anecdotal experience of the authors. However, the case series by Anuwong and colleagues remains that of a single institution; thus, it remains unclear whether the low rate of infection, recurrent laryngeal nerve injury, and hypoparathyroidism rates can be replicated by other surgeons.

Early reports from the United States are promising, however. In addition, the incidence of other technique-specific complications remains unknown. The only way to prove that other surgeons can in fact replicate the success shown in the study by Anuwong et al is with a multicenter, multi-surgeon trial. While these data are accumulating, training and adoption of the new technique should be done in a safe and thoughtful manner. 

Second, it must be demonstrated whether the absence of a cutaneous incision either improves quality of life or adds value for patients. Again, data are limited in this regard. Given that the present study shows that hundreds of thousands of patients with thyroid and parathyroid disease could be treated with TES in the United States, we believe our findings strongly support the need for definitive studies on safety and efficacy. Other questions regarding the procedure, such as cost, physician perceptions, and patient-centered outcomes, could also be answered by a trial.

Although incision size is not the only criterion that classifies an operation as minimally invasive, some consider the traditional approach to focused parathyroidectomies to already be minimally invasive, if it is performed with a 2-cm incision. If that is the case, the merits of moving that 2-cm incision from the neck to the inside of the lower lip may be questioned by some. However, it is not clear how many surgeons actually perform a “minimally invasive” parathyroidectomy via a 2-cm incision. In addition, recent advances in TES parathyroidectomy have reduced the total incision size to 1 cm in select cases through the use of pediatric laparoscopic trocars. If the operation is as safe as the traditional approach, we believe the preference of avoiding a cervical scar should be left to individual patients as long as they are eligible for TES. The patient’s autonomy in choosing TES is especially relevant because it has been demonstrated that patients are concerned about cervical scars no matter how well they heal or how small they are. However, even if the parathyroidectomies are removed from the indications for TES in this population, there are still more than 80 000 patients undergoing thyroidectomies done each year in the United States who are potentially eligible for this scarless technique, thus justifying further exploration of this approach.

As stated, the value of not having a scar on the neck has been questioned. However, data continue to accumulate showing that scars, particularly in very prominent locations such as the front of the neck, are bothersome to some people, and if given a choice many would prefer to not have that scar visible. Previous US studies have concluded that more than 10% of patients undergoing thyroidectomy consider a scar revision even years after surgery, and that 50% of patients are “extremely satisfied” with their scar. 

Preliminary data from Johns Hopkins University have shown that there is a penalty in overall attractiveness for patients with a Kocher incision, and that patients would be willing to pay more than $10 000 to avoid this incision. In that same study, the authors demonstrated that, in patients who underwent a TES procedure, there was no attractiveness penalty. Although the value of avoiding a cervical incision remains to be fully studied, it is apparent that at least some patients or potential patients prefer to avoid a cervical incision, even if there is additional surgical risk or cost.

Our data demonstrated that TES was applicable to more than half of all open thyroid and parathyroid surgery candidates in academic practices included in this study when standard inclusion and exclusion criteria were applied. Results of this study suggest that there are potentially hundreds of thousands of patients who may be eligible to forego a cutaneous incision. We believe these data show that TES is not and should not be considered an operation with limited applicability. Transoral endocrine surgery has the potential to improve the lives of a large number of patients, and thus it should be considered a viable option in the United States.

Based on these data, a large, prospective multicenter trial is warranted to further evaluate the safety, clinical outcomes, patient-centered outcomes, and costs of TES.