Retro-Auricular Single-Site Endoscopic to Papillary Thyroid Carcinoma

NCT05263141 | Completed DMC

• 1 other identifier: B2022-012-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this non randomized control clinical research study is to compare the cosmetic outcomes and efficiacy of retro-auricular single-site endoscopic thyroid lobectomy and central lymph node dissection against conventional resection.

Conditions

Papillary Thyroid Carcinoma

Keywords

Papillary Thyroid Carcinoma; Thyroidectomy; Laparoscopy; Retroauricular approach; Single-site

Outcome Measures

Primary Outcomes (1)

• postoperative cosmetic satisfaction scores

  The cosmetic satisfaction score(CSS) was defined as the sum of the scores on questions about the scar. Q1 and Q2 was using a verbal response scale from 1 to 5 (corresponding to decreasing satisfaction). The other four questions, each on a scale of 0 to 3 (again of decreasing satisfaction).

  3 months from surgery

Secondary Outcomes (4)

• postoperative Vancouver Scar Scale

  3 months from surgery

• postoperative Vancouver Scar Scale

  1 month from surgery

• Intra-operative, peri-operative, post-operative clinicopathologic characteristics

  1 week from surgery

• postoperative cosmetic satisfaction scores

  1 month from surgery

Study Arms (2)

RASSET group

EXPERIMENTAL

Patients in the retro-auricular single-site endoscopic thyroidectomy (RASSET) group will receive endoscopic thyroid lobectomy and central lymph node dissection.

Procedure: retro-auricular single-site endoscopic thyroidectomy

traditional open thyroid lobectomy group

ACTIVE COMPARATOR

Patients in the traditional open thyroid lobectomy group will receive thyroid lobectomy and central lymph node dissection.

Procedure: traditional open surgery thyroidectomy

Interventions

retro-auricular single-site endoscopic thyroidectomy PROCEDURE

The strap muscles and the sternocleidomastoid muscle were separated. Upper parathyroid and lower parathyroid glands were identified and preserved. The recurrent laryngeal nerve (RLN) was identified，A lobe of thyroid specimen and central lymph nodes were dissected.

Also known as: RASSET

RASSET group

traditional open surgery thyroidectomy PROCEDURE

The strap muscles were separated in the midline to expose the thyroid gland. Upper parathyroid and lower parathyroid glands were identified and preserved. The recurrent laryngeal nerve (RLN) was identified， a lobe of thyroid specimen and central lymph nodes were dissected.

traditional open thyroid lobectomy group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 years old, no gender restrictions.
• Fine-needle aspiration cytology(FNA) confirmed papillary thyroid carcinoma(PTC).
• Early stage PTC (stage T1N0M0).
• Preoperative ultrasonography showed unilateral glandular lobe malignant tumor and the largest diameter was not more than 2cm, without cervical lymph node metastasis and extensive metastasis.
• Patients undergoing thyroid lobectomy and central lymph node dissection.
• Patients who have signed an approved Informed Consent.

You may not qualify if:

• Patients who do not accept case data collection for various reasons.
• The clinical data unfit this study (at the discretion of the investigator).
• Patients who have undergone neck surgery or radiotherapy before this trail.
• Patients who have uncontrolled hyperthyroidism.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Location

Related Publications (11)

• Anuwong A, Ketwong K, Jitpratoom P, Sasanakietkul T, Duh QY. Safety and Outcomes of the Transoral Endoscopic Thyroidectomy Vestibular Approach. JAMA Surg. 2018 Jan 1;153(1):21-27. doi: 10.1001/jamasurg.2017.3366.

  PMID: 28877292 BACKGROUND

• Lee DW, Ko SH, Song CM, Ji YB, Kim JK, Tae K. Comparison of postoperative cosmesis in transaxillary, postauricular facelift, and conventional transcervical thyroidectomy. Surg Endosc. 2020 Aug;34(8):3388-3397. doi: 10.1007/s00464-019-07113-1. Epub 2019 Sep 12.

  PMID: 31515625 BACKGROUND

• Dong F, Ao Y, Li MT, Zhan ZR, Lin YQ, Tan QJ, Li H, Yang AK, Ouyang D. [A comparative study between retro-auricular single-site endoscopic thyroidectomy and transoral endoscopic thyroidectomy vestibular approach: a single-center retrospective analysis]. Zhonghua Wai Ke Za Zhi. 2021 Nov 1;59(11):891-896. doi: 10.3760/cma.j.cn112139-20210903-00420. Chinese.

  PMID: 34743449 BACKGROUND

• Schardey HM, Schopf S, Kammal M, Barone M, Rudert W, Hernandez-Richter T, Portl S. Invisible scar endoscopic thyroidectomy by the dorsal approach: experimental development of a new technique with human cadavers and preliminary clinical results. Surg Endosc. 2008 Apr;22(4):813-20. doi: 10.1007/s00464-008-9761-y. Epub 2008 Feb 23.

  PMID: 18297357 BACKGROUND

• Berber E, Bernet V, Fahey TJ 3rd, Kebebew E, Shaha A, Stack BC Jr, Stang M, Steward DL, Terris DJ; American Thyroid Association Surgical Affairs Committee. American Thyroid Association Statement on Remote-Access Thyroid Surgery. Thyroid. 2016 Mar;26(3):331-7. doi: 10.1089/thy.2015.0407.

  PMID: 26858014 BACKGROUND

• Russell JO, Razavi CR, Al Khadem MG, Lopez M, Saraf S, Prescott JD, Starmer HM, Richmon JD, Tufano RP. Anterior cervical incision-sparing thyroidectomy: Comparing retroauricular and transoral approaches. Laryngoscope Investig Otolaryngol. 2018 Sep 24;3(5):409-414. doi: 10.1002/lio2.200. eCollection 2018 Oct.

  PMID: 30410996 BACKGROUND

• Nguyen HX, Nguyen HX, Nguyen HV, Nguyen LT, Nguyen TTP, Le QV. Transoral Endoscopic Thyroidectomy by Vestibular Approach with Central Lymph Node Dissection for Thyroid Microcarcinoma. J Laparoendosc Adv Surg Tech A. 2021 Apr;31(4):410-415. doi: 10.1089/lap.2020.0411. Epub 2020 Jul 17.

  PMID: 32706603 BACKGROUND

• Nakajo A, Arima H, Hirata M, Mizoguchi T, Kijima Y, Mori S, Ishigami S, Ueno S, Yoshinaka H, Natsugoe S. Trans-Oral Video-Assisted Neck Surgery (TOVANS). A new transoral technique of endoscopic thyroidectomy with gasless premandible approach. Surg Endosc. 2013 Apr;27(4):1105-10. doi: 10.1007/s00464-012-2588-6. Epub 2012 Nov 21.

  PMID: 23179070 BACKGROUND

• Duek I, Duek OS, Fliss DM. Minimally Invasive Approaches for Thyroid Surgery-Pitfalls and Promises. Curr Oncol Rep. 2020 Jun 29;22(8):77. doi: 10.1007/s11912-020-00939-2.

  PMID: 32601931 BACKGROUND

• Chung EJ, Park MW, Cho JG, Baek SK, Kwon SY, Woo JS, Jung KY. A prospective 1-year comparative study of endoscopic thyroidectomy via a retroauricular approach versus conventional open thyroidectomy at a single institution. Ann Surg Oncol. 2015 Sep;22(9):3014-21. doi: 10.1245/s10434-014-4361-7. Epub 2015 Jan 21.

  PMID: 25605517 BACKGROUND

• Schardey HM, Barone M, Portl S, von Ahnen M, von Ahnen T, Schopf S. Invisible scar endoscopic dorsal approach thyroidectomy: a clinical feasibility study. World J Surg. 2010 Dec;34(12):2997-3006. doi: 10.1007/s00268-010-0769-9.

  PMID: 20835708 BACKGROUND

MeSH Terms

Conditions

Thyroid Cancer, Papillary

Condition Hierarchy (Ancestors)

Adenocarcinoma, Papillary; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Dian Ouyang

  Sun Yat-sen University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 20, 2022
• First Posted: March 2, 2022
• Study Start: March 1, 2022
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: December 3, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)