Clinical trial NCT06671184: Nomogram for Predicting Difficult Transoral and Submental Thyroidectomy
Official title: Nomogram for Predicting Difficult Transoral and Submental Thyroidectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Differentiated Thyroid Cancer
Keywords: Differentiated thyroid cancer
Transoral and submental thyroidectomy
Surgical difficulty
Lead sponsor: Shanghai 6th People's Hospital
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with FNA proven differentiated thyroid cancer, were willing to undergo total thyroidectomy and central lymph node dissection via transoral and submental approach. Patients were well informed about the transoral and submental approach and were aware of the potential benefits and risks. Patient consented for us to use perioperative data.

Brief summary: No prior studies have stratified the difficulty of transoral and submental thyroidectomy (TOaST). The investigators aimed to investigate preoperative factors as indicators of difficult TOaSTs and to develop a predictive model accordingly.

Detailed description: Thyroid cancer is the most common endocrine malignancy, with a female predominance. Thyroidectomy is the main treatment for thyroid cancer, and considering the good prognosis of thyroid cancer, endoscopic thyroid surgery, which avoids neck incision, is being widely used in the clinic in order to improve the life treatment of patients. Among them, endoscopic thyroidectomy with transoral approach has a shorter learning curve because of the short surgical path. However, due to the complex structure of the neck, small space, and rich blood supply of the thyroid gland, surrounded by parathyroid glands and important nerves, endoscopic thyroid is difficult and has a long learning curve. In addition, a series of complications such as haemorrhage, hypoparathyroidism and laryngeal reentrant nerve injury can seriously affect the quality of patient survival. Difficult thyroidectomy is usually characterized by a long operative time, high intraoperative bleeding and a high incidence of postoperative complications. According to the literature, in open thyroid surgery, the degree of difficulty is associated with factors such as goiter, inflammation, and hyperthyroidism. However, the degree of difficulty of thyroidectomy due to various factors varies and is difficult to predict. Surgical difficulty is closely related to the outcome and safety of thyroidectomy, which is an urgent concern for surgeons. And there is no study on the degree of difficulty of transoral and submental endoscopic thyroidectomy, therefore, there is an urgent need for an effective and objective method to determine the preoperative factors affecting the degree of surgical difficulty and to establish a model for validation, so that it can be subsequently replicated in other hospitals.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of differentiated thyroid cancer with a maximum diameter not exceeding 4 cm
* Absence of suspicious lateral lymph nodes or distant metastases
* Participants with high cosmetic expectations
* Participants who underwent total thyroidectomy and central lymph node dissection.

Exclusion Criteria:

* Participants with fusion or fixation of lymph nodes in the neck
* Participants with history of neck surgery or radiation
* Participants with vocal fold fixation by preoperative fibrolaryngoscope
* Participants with preoperative examination suggestive of extrathyroidal invasion
* Participants with a significantly restricted neck

Primary outcomes:
measure: Number of participants with recurrent laryngeal nerve injury
timeFrame: through study completion, an average of 1 year
measure: Number of participants with hypoparathyroidism
timeFrame: through study completion, an average of 1 year
measure: Number of participants with mental nerve injury
timeFrame: through study completion, an average of 1 year
measure: operative time
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: hospitalization
timeFrame: through study completion, an average of 1 year
measure: degree of pain
timeFrame: approximately 4 hours after surgery and on postoperative day 1
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
state: Shanghai
Study officials:
affiliation: Shanghai 6th People's Hospital
name: Ling Zhan, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhan L, Xuan M, Ding H, Liang J, Zhao Q, Chen L, Yang Z, Cheng X, Kuang J, Yan J, Cai W, Qiu W. Learning curve of trans-areola single-site endoscopic thyroidectomy in a high-volume center: A CUSUM-based assessment. Cancer Med. 2023 Aug;12(16):16846-16858. doi: 10.1002/cam4.6307. Epub 2023 Jul 3.
citation: Liang J, Zhan L, Xuan M, Zhao Q, Chen L, Yan J, Kuang J, Tan J, Qiu W. Thyroidectomy for thyroid cancer via transareola single-site endoscopic approach: results of a case-match study with large-scale population. Surg Endosc. 2022 Feb;36(2):1394-1406. doi: 10.1007/s00464-021-08424-y. Epub 2021 Mar 29.