Safety of Endoscopic Thyroidectomy Via Retro-Auricular Single-Site Approach, Transoral Approach and Transareola

NCT05760690 | Completed DMC

• 1 other identifier: B2022-359-01
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this retrospective study is to compare the safety and efficiacy of endoscopic thyroidectomy via retro-auricular single-site approach, transoral endoscopic thyroidectomy vestibular approach and transareola approach.

Conditions

Papillary Thyroid Carcinoma

Keywords

Papillary Thyroid Carcinoma Laparoscopy; Endoscopic Thyroidectomy; Retroauricular Single-site approach; Transoral Endoscopic Thyroidectomy Vestibular Approach; Transareola Endoscopic Thyroidectomy

Outcome Measures

Primary Outcomes (1)

• C-reactive protein，CRP

  the level of CRP before and after operation

  1 week

Secondary Outcomes (4)

• Serum Amyloid A，SAA

  1 week

• blood loss

  1 week

• VAS pain score

  2 days after operation

• number of lymph nodes

  1 week after operation

Study Arms (3)

Retro-Auricular Single-Site Endoscopic Thyroidectomy 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

Transoral Endoscopic Thyroidectomy Vestibular Approach group

ACTIVE COMPARATOR

Patients in the Transoral Endoscopic Thyroidectomy Vestibular Approach group will receive endoscopic thyroid lobectomy and central lymph node dissection.

Procedure: Transoral Endoscopic Thyroidectomy Vestibular Approach

Transareola Endoscopic Thyroidectomy group

ACTIVE COMPARATOR

Patients in the Transareola Endoscopic Thyroidectomy group will receive endoscopic thyroid lobectomy and central lymph node dissection.

Procedure: Transareola Endoscopic 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.

Retro-Auricular Single-Site Endoscopic Thyroidectomy group

Transoral Endoscopic Thyroidectomy Vestibular Approach PROCEDURE

The patient was placed in a supine position with slight neck extension under nasotracheal intubation. The mouth was garbled with povidone iodine before surgery. Three laparoscopic ports (a 10- to 15-mm port at midline and two 5-mm ports at the lateral junction between the canine and first premolar teeth)were inserted under the lower lip at the oral vestibular area.The strap muscleswere separated in the midline to expose the thyroid and trachea. The recurrent laryngeal nerve (RLN) was identified at the insertion to the larynx, then followed downandparallel tothe trachea inferiorly.

Transoral Endoscopic Thyroidectomy Vestibular Approach group

Transareola Endoscopic Thyroidectomy PROCEDURE

The patient was in supine position. Incision was made inside the right areola and a 10mm puncture device was placed, subcutaneous separation rod was used to separate the space, and a 30° endoscope was introduced, puncture device was placed in a 5mm incision on the left areola, ultrasonic knife free flap was used, subcutaneous separation space was placed in the upper sternal segment, and a 5mm puncture device was placed outside the right areola. The anterior cervical flap was further dissociated to establish a space. The median cervical line was cut to cut off the isthmus of the thyroid, and the tracheal fascia ligament of the thyroid was separated and the nerve was exposed to protect the nerves. Then remove the lobe of thyroid and central lymph nodes

Transareola Endoscopic Thyroidectomy 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, 510060, China

Location

Related Publications (9)

• Dong F, Yang A, Ouyang D. Retroauricular Single-Site Endoscopic Thyroidectomy-A Balanced Endoscopic Approach for Thyroid Excision. JAMA Surg. 2023 May 1;158(5):548-549. doi: 10.1001/jamasurg.2022.7723.

  PMID: 36753130 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

• Liang TJ, Chen IS, Liu SI. Working Space Creation in Transoral Thyroidectomy: Pearls and Pitfalls. Cancers (Basel). 2022 Feb 17;14(4):1031. doi: 10.3390/cancers14041031.

  PMID: 35205779 BACKGROUND

• Sun H, Zheng H, Wang X, Zeng Q, Wang P, Wang Y. Comparison of transoral endoscopic thyroidectomy vestibular approach, total endoscopic thyroidectomy via areola approach, and conventional open thyroidectomy: a retrospective analysis of safety, trauma, and feasibility of central neck dissection in the treatment of papillary thyroid carcinoma. Surg Endosc. 2020 Jan;34(1):268-274. doi: 10.1007/s00464-019-06762-6. Epub 2019 Jul 25.

  PMID: 31346748 BACKGROUND

• Ikeda Y, Takami H, Niimi M, Kan S, Sasaki Y, Takayama J. Endoscopic thyroidectomy and parathyroidectomy by the axillary approach. A preliminary report. Surg Endosc. 2002 Jan;16(1):92-5. doi: 10.1007/s004640080175. Epub 2001 Nov 12.

  PMID: 11961613 BACKGROUND

• 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

• 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

• Sephton BM. Extracervical Approaches to Thyroid Surgery: Evolution and Review. Minim Invasive Surg. 2019 Aug 20;2019:5961690. doi: 10.1155/2019/5961690. eCollection 2019.

  PMID: 31531238 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

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 13, 2023
• First Posted: March 8, 2023
• Study Start: January 1, 2015
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 3, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)