NCT06671184

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Jan 2021Dec 2027

Study Start

First participant enrolled

January 1, 2021

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 4, 2024

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

7 years

First QC Date

October 30, 2024

Last Update Submit

May 2, 2026

Conditions

Differentiated Thyroid Cancer

Keywords

Differentiated thyroid cancerTransoral and submental thyroidectomySurgical difficulty

Outcome Measures

Primary Outcomes (4)

  • Number of participants with recurrent laryngeal nerve injury

    impaired vocal cord mobility confirmed by postoperative laryngoscopy

    through study completion, an average of 1 year

  • Number of participants with hypoparathyroidism

    a postoperative parathyroid hormone level of less than 10 pg/ml

    through study completion, an average of 1 year

  • Number of participants with mental nerve injury

    a postoperative numbness in the lower lip and submental area

    through study completion, an average of 1 year

  • operative time

    operative time was defined as the duration from incision to closure, and was collected from anesthesia record sheet

    through study completion, an average of 1 year

Secondary Outcomes (2)

  • hospitalization

    through study completion, an average of 1 year

  • degree of pain

    approximately 4 hours after surgery and on postoperative day 1

Study Arms (2)

Difficult transoral and submental thyroidectomy

(1) operative time more than 75% of the overall study cases (2) severe intraoperative vascular or recurrent laryngeal nerve injury

Other: Observations on clinicopathological factors influencing the difficulty of surgery

Normal transoral and submental thyroidectomy

the remaining of the entire study cases excluding the difficult cases

Other: Observations on clinicopathological factors influencing the difficulty of surgery

Interventions

Observations on clinicopathological factors influencing the difficulty of surgeryOTHER

Age, body mass index, gender, thyroid function parameters, lesion size, lesion location, ultrasound data

Difficult transoral and submental thyroidectomyNormal transoral and submental thyroidectomy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 37395126RESULT

  • 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.

    PMID: 33782758RESULT

Study Officials

  • Ling Zhan, Doctor

    Shanghai 6th People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ling Zhan, Doctor

CONTACT

08615821120972rebecca0428zhan@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

October 30, 2024

First Posted

November 4, 2024

Study Start

January 1, 2021

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

May 7, 2026

Record last verified: 2026-05

Locations

CN(1)