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

December 29, 2024 updated by: First Affiliated Hospital of Wenzhou Medical University

Dual-port Trans-subclavian Thyroid Endoscopic Surgery - an Exploration of Cavity Construction in Situ Heralds a New Approach Choice

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In the past years, the prevalence of thyroid cancer (TC) has increased markedly across numerous regions and nations. 94% of TC are differentiated thyroid carcinomas (DTC), and thyroidectomyis widely accepted as the most optimal therapeutic option for patients diagnosed with DTC. The conventional method for performing thyroidectomy is through an open approach known as collar incision thyroidectomy, or conventional open thyroidectomy (COT), which is commonly recognized as the standard technique.

Endoscopic thyroid surgery is a relatively new approach to thyroid surgery that was first developed in the 1990s. In 1996, Dr. Hiischer, an Italian surgeon, performed the first endoscopic right thyroid lobectomy. Recently, with the advent of intraoperative neuromonitoring (IONM), a technique for monitoring recurrent laryngeal nerve (RLN) function during surgery, complications of RLN injury have been effectively reduced. The introduction of high-definition endoscopy and robotic surgery in endoscopic thyroid procedures has significantly enhanced visual precision, enabling surgeons to perform complex maneuvers with increased accuracy, thereby minimizing the risk of complications and tissue injury. With the advancement of these technologies, various endoscopic thyroidectomy techniques have been developed, including chest-breast, transoral, and transaxillary approaches.

However, in comparison to COT, endoscopic thyroid surgery incurs greater trauma. This is primarily attributed to the absence of initial spaces in the neck, unlike the thoracic and abdominal cavities. Previous endoscopic procedures required creating a cavity from a distance before extending it to the neck, leading to a direct increase in the surgical trauma area. Consequently, patients undergoing endoscopic thyroid surgery may endure more substantial surgical trauma, exacerbated postoperative pain, and prolonged hospitalization. Hence, some scholars argue that the transformation of endoscopic thyroid surgery into a genuinely 'minimally invasive procedure'; necessitates further refinement.

To address the aforementioned issue, the investigators propose a pioneering approach: Dual-port Trans-subclavian Thyroid Endoscopic Surgery (DTS) . DTS has the following advantages: 1) The investigators employed two 1cm puncture holes, thereby reducing the incision-related trauma to the skin and subcutaneous tissues, significantly alleviating surgical trauma and postoperative pain in patients. 2) The previous endoscopic approach involves creating an additional cavity, leading to additional trauma, whereas our method is directly constructing the cavity in situ within the neck. 3) Our endoscopic visual field is well-exposed, ensuring thorough clearance of central compartment lymph node.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chun Jin, Professor
  • Phone Number: 86-13858707259
  • Email: 845095442@qq.com

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • First Affiliated Hospital of Wenzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DTS group
Patients undergo Dual-port Trans-subclavian Thyroid Endoscopic Surgery (DTS)
Procedure: Dual-port Trans-subclavian Thyroid Endoscopic Surgery (DTS).
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.
Active Comparator: COT group
Patients undergo conventional open thyroidectomy (COT)
Procedure: Conventional open thyroidectomy (COT)
open thyroidectomy with traditional collar incisions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of postoperative complications
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Wenzhou Medical University

Investigators

  • Principal Investigator: Jiashu Wu, Profe, The first hospital of Wenzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 22, 2024

First Submitted That Met QC Criteria

May 2, 2024

First Posted (Actual)

May 3, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 29, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YLJS-2022036-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Thyroid Neoplasms

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe