Dual-port Trans-subclavian Thyroid Endoscopic Surgery

Thyroid Neoplasms Clinical Trial

— DTS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06398795
• Other study ID #: YLJS-2022036-01
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: September 1, 2024

Study information

• Verified date: April 2024
• Source: First Affiliated Hospital of Wenzhou Medical University
• Contact: Chun Jin, Professor
• Phone: 86-13858707259
• Email: 845095442[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Endoscopic Surgery
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

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.
• Conventional open thyroidectomy (COT)
open thyroidectomy with traditional collar incisions

Locations

Country	Name	City	State
China	First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.

External Links

•   JIN Chun. Analysis of thyroid endoscopic surgery by two-hole trans-subclavian approach[J]. JOURNAL OF WEZHOU MEDICAL UNIVERSITY, 2022, 52(12): 1005-1008.