Clinical trial NCT06995599: Impact of Thoracic Duct Ligation on Postoperative Weight Reduction in Obese Patients Receiving Minimally Invasive Lung Surgery: A Clinical Investigation
Official title: Thoracic Duct Ligation and Postoperative Weight Loss in Obese Patients Undergoing Minimally Invasive Lung Surgery: A Pilot Exploratory Clinical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obese Patients
Keywords: Obesity
therapy
Metabolic Effects of Thoracic Duct Ligation
Lead sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine
Sponsor class: OTHER
First posted: 2025-05-29
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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).
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Height and weight (for BMI calculation)
timeFrame: 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 .
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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