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

NCT06995599 | Not Yet Recruiting

• 1 other identifier: Ethics Review No. 2025-003
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obese Patients

Keywords

Obesity; therapy; Metabolic Effects of Thoracic Duct Ligation

Outcome Measures

Primary Outcomes (1)

• Height and weight (for BMI calculation)

  Height and weight (for BMI calculation)

  Height and weight (for BMI calculation) : Measured at baseline, postoperative 1/4/ 7/10/13/19/25/37months.;Lipid profile (LDL/HDL): Baseline, postoperative 1/5day, 1/4/ 7/10/13/19/25/37months.Participants will be followed for up to 36 months .

Study Arms (1)

Thoracic Duct Ligation (TDL)

EXPERIMENTAL

Procedure: Thoracic Duct Ligation (TDL)

Interventions

Thoracic Duct Ligation (TDL) 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.

Thoracic Duct Ligation (TDL)

Eligibility Criteria

• Age: 18 Days - 75 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age \& Gender: Individuals aged 18-75 years, regardless of gender.
• Clinical Profile:Diagnosed with early-stage lung cancer (stage IA1-IB) and obesity (BMI ≥28 kg/m²).
• Scheduled to undergo video-assisted thoracoscopic surgery (VATS) for right-sided lung cancer resection at our institution between October 2024 and October 2026.
• Surgical Eligibility: Approved for surgery following multidisciplinary team (MDT) assessment.
• Treatment Plan: No requirement for adjuvant therapy post-lung resection.
• Preoperative Evaluation:Completed standard preoperative workup, including:
• Chest CT、Brain CT/MRI、Abdominal ultrasound OR PET-CT to rule out distant metastasis.
• Informed Consent: Willing and able to comply with study requirements, with written informed consent provided.

You may not qualify if:

• Concurrent Thoracic Infections: Patients with active intrathoracic infectious diseases (e.g., inflammatory conditions, tuberculosis).
• Refusal of Novel Technique: Patients unwilling to undergo intraoperative thoracic duct ligation.
• Clinically Unstable Comorbidities: Severe, unstable cardiovascular, renal, or respiratory disorders.
• Prior Bariatric Surgery: History of weight-loss surgery (e.g., gastric bypass, sleeve gastrectomy).
• Recent Trial Participation: Enrollment in other clinical trials within 30 days prior to screening.
• Investigator Discretion: Other conditions deemed by the investigator to contraindicate participation.

Sponsors & Collaborators

• Yongxin Zhou: lead

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

YongXin Zhou

CONTACT

021 13681666828; zhou6302@tongji.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Surgeon, Department of Thoracic Surgery

Model Details: Primary comparison: Preoperative (baseline) vs. postoperative parameters within the same cohort. Secondary comparison: Outcomes compared to historical controls (patients who underwent lung surgery without thoracic duct ligation).

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: May 29, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share