Clinical trial NCT06398795: Dual-port Trans-subclavian Thyroid Endoscopic Surgery
Official title: Dual-port Trans-subclavian Thyroid Endoscopic Surgery - an Exploration of Cavity Construction in Situ Heralds a New Approach Choice
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thyroid Neoplasms
Endoscopic Surgery
Lead sponsor: First Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2024-05-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The incidence of postoperative complications
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: The first hospital of Wenzhou Medical University
name: Jiashu Wu, Profe
role: PRINCIPAL_INVESTIGATOR
References: