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

Y

Yongxin Zhou

Status

Not yet enrolling

Conditions

Obese Patients

Treatments

Procedure: Thoracic Duct Ligation (TDL)

Study type

Interventional

Funder types

Other

Identifiers

NCT06995599
Ethics Review No. 2025-003

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 estimated patients

Sex

All

Ages

18 to 75 days old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

16 participants in 1 patient group

Thoracic Duct Ligation (TDL)
Experimental group
Treatment:
Procedure: Thoracic Duct Ligation (TDL)

Trial contacts and locations

0

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Central trial contact

YongXin Zhou

Data sourced from clinicaltrials.gov

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