Impact of Thoracic Duct Ligation on Postoperative Weight Reduction in Obese Patients Receiving Minimally Invasive Lung Surgery: A Clinical Investigation

NCT ID: NCT06995599

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2027-12-31

Brief Summary

This clinical trial aims to investigate whether thoracic duct ligation (TDL) can improve obesity and lipid metabolism. The primary questions it seeks to answer are:

Whether thoracic duct ligation can improve BMI and lipid metabolism in obese patients.

The safety and feasibility of thoracic duct ligation as a treatment for obesity.

Detailed Description

Background:

Obesity (BMI≥28 kg/m²) is a global health crisis with limited effective interventions. Emerging evidence suggests that TDL-a routine step in esophagectomy-may reduce body weight and improve lipid profiles, but its therapeutic potential for metabolic modulation remains unexplored.

Objectives:

Primary: Assess safety and feasibility of TDL during video-assisted thoracoscopic surgery (VATS) for stage IA1-IB lung cancer with concurrent obesity (BMI≥30 kg/m²).

Secondary: Evaluate changes in body weight (%), lipid metabolism (LDL/HDL), inflammatory markers (CRP, IL-6), and fat-soluble vitamin levels.

Methods:

Single-center prospective cohort with longitudinal monitoring. Eligible patients will undergo VATS + TDL, with metabolic parameters measured preoperatively and at postoperative day 1/5, months 1/3/6/12.

Exploratory Endpoints:

• Weight loss trajectory (% total body weight)
• Mechanisms of metabolic reprogramming (e.g., gut hormone shifts)
• Procedure-related morbidity (lymphatic leakage, vitamin deficiency)

Significance:

First study to evaluate TDL as a potential metabolic therapy in non-esophageal surgery, providing preliminary data for future randomized trials.

Conditions

Obese Patients

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Thoracic Duct Ligation (TDL)

Group Type: EXPERIMENTAL

Thoracic Duct Ligation (TDL)

Intervention Type: PROCEDURE

Following the minimally invasive right-sided lung cancer resection, during mediastinal lymph node dissection, the posterior aspect of the azygos vein is identified. The mediastinal pleura is then longitudinally incised along the medial border of the azygos vein and posterior to the esophagus. Between the azygos vein and aorta, the thoracic duct is meticulously localized as a milky-white translucent structure measuring 2-3 mm in diameter. A 5-mm segment of the duct is carefully mobilized and double-clamped with vascular clips under direct thoracoscopic visualization. The surgical field is thoroughly inspected to confirm the absence of chylous leakage, and the procedure is concluded after standard closure and confirmation of hemostasis.

Interventions

Thoracic Duct Ligation (TDL)

Following the minimally invasive right-sided lung cancer resection, during mediastinal lymph node dissection, the posterior aspect of the azygos vein is identified. The mediastinal pleura is then longitudinally incised along the medial border of the azygos vein and posterior to the esophagus. Between the azygos vein and aorta, the thoracic duct is meticulously localized as a milky-white translucent structure measuring 2-3 mm in diameter. A 5-mm segment of the duct is carefully mobilized and double-clamped with vascular clips under direct thoracoscopic visualization. The surgical field is thoroughly inspected to confirm the absence of chylous leakage, and the procedure is concluded after standard closure and confirmation of hemostasis.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age & Gender: Individuals aged 18-75 years, regardless of gender.

2. Clinical Profile:Diagnosed with early-stage lung cancer (stage IA1-IB) and obesity (BMI ≥28 kg/m²).

3. Scheduled to undergo video-assisted thoracoscopic surgery (VATS) for right-sided lung cancer resection at our institution between October 2024 and October 2026.

4. Surgical Eligibility: Approved for surgery following multidisciplinary team (MDT) assessment.

5. Treatment Plan: No requirement for adjuvant therapy post-lung resection.

6. Preoperative Evaluation:Completed standard preoperative workup, including:

7. Chest CT、Brain CT/MRI、Abdominal ultrasound OR PET-CT to rule out distant metastasis.

8. Informed Consent: Willing and able to comply with study requirements, with written informed consent provided.

Exclusion Criteria

1. Concurrent Thoracic Infections: Patients with active intrathoracic infectious diseases (e.g., inflammatory conditions, tuberculosis).

2. Refusal of Novel Technique: Patients unwilling to undergo intraoperative thoracic duct ligation.

3. Clinically Unstable Comorbidities: Severe, unstable cardiovascular, renal, or respiratory disorders.

4. Prior Bariatric Surgery: History of weight-loss surgery (e.g., gastric bypass, sleeve gastrectomy).

5. Recent Trial Participation: Enrollment in other clinical trials within 30 days prior to screening.

6. Investigator Discretion: Other conditions deemed by the investigator to contraindicate participation.

• Minimum Eligible Age: 18 Days
• Maximum Eligible Age: 75 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yongxin Zhou

OTHER

Sponsor Role: lead

Responsible Party

Yongxin Zhou

Chief Surgeon, Department of Thoracic Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

YongXin Zhou

Role: CONTACT

zhou6302@tongji.edu.cn

021 13681666828

Other Identifiers

Ethics Review No. 2025-003

Identifier Type: -

Identifier Source: org_study_id