Dual-port Trans-subclavian Thyroid Endoscopic Surgery

NCT06398795 | Recruiting

• 1 other identifier: YLJS-2022036-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single-center, open-label, non-randomized controlled real-world study aimed at exploring a novel approach to cavity construction for thyroid endoscopic surgery. The study seeks to evaluate its effectiveness and safety while accumulating further evidence-based medical data. Three hundred patients with thyroid tumors were divided into an experimental group (150 cases receiving a new endoscopic thyroid surgery technique, namely, dual-port trans-subclavian thyroid endoscopic surgery) and a control group (150 cases undergoing traditional open thyroid surgery) according to their treatment intention. Laboratory and medical data from specified follow-up points are collected, and adverse events are recorded detailly. The primary efficacy endpoint is a comparison of surgical complications between the two treatment groups. Secondary endpoints include: (1) levels of IL-2, IL-4, IL-6, IL-10, TNF-α, INF-γ, renin, angiotensin II, and aldosterone preoperatively and on the second day postoperatively; (2) NRS scores on the first day postoperatively; (3) length of hospital stay, duration of surgery, total treatment cost, and postoperative drainage volume; and (4) assessment of wound satisfaction during a three-month follow-up visit. Safety assessments include adverse events, vital signs, and pathological examinations.

Conditions

Thyroid Neoplasms; Endoscopic Surgery

Outcome Measures

Primary Outcomes (1)

• The incidence of postoperative complications

  The incidence of postoperative complications including recurrent laryngeal nerve injury, hypoparathyroidism, chyle leakage, infection and so on.

  From the date of grouping to the first recorded progression of relapse or the date of death due to any cause, whichever came first, assessed up to 100 months.

Study Arms (2)

DTS group

EXPERIMENTAL

Patients undergo Dual-port Trans-subclavian Thyroid Endoscopic Surgery (DTS)

Procedure: Dual-port Trans-subclavian Thyroid Endoscopic Surgery (DTS).

COT group

ACTIVE COMPARATOR

Patients undergo conventional open thyroidectomy (COT)

Procedure: Conventional open thyroidectomy (COT)

Interventions

Dual-port Trans-subclavian Thyroid Endoscopic Surgery (DTS). PROCEDURE

An innovative surgical approach, Dual-port Trans-subclavian Thyroid Endoscopic Surgery (DTS), presents a unique dual-port endoscopic technique for thyroidectomy. DTS significantly reduces postoperative hospital stay, emphasizing its potential for accelerated patient recovery compared to COT.

DTS group

Conventional open thyroidectomy (COT) PROCEDURE

open thyroidectomy with traditional collar incisions

COT group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Thyroid cancer or benign thyroid tumors
• Patients with a demand for incisional cosmetic improvement

You may not qualify if:

• Patients with thyroid cancer larger than 2 cm
• benign tumors larger than 5 cm
• Patients with severe underlying diseases
• Patients with chronic kidney disease,
• Patients with autoimmune diseases
• Patients with rheumatoid arthritis

Sponsors & Collaborators

• First Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Jiashu Wu, Profe

  The first hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun Jin, Professor

CONTACT

86-13858707259; 845095442@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: May 3, 2024
• Study Start: September 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)