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NCT Number: NCT06995599

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

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.

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Key information

Age range

18 day–75 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Height and weight (for BMI calculation)

    Time frame: 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 .

    Height and weight (for BMI calculation)

Study contacts

Contact information is provided by the study sponsor or research team.

YongXin Zhou

CONTACT

[email protected]

021 13681666828

Sponsors and collaborators

Lead sponsor

Yongxin Zhou

Other

Registry information

Official study title

Thoracic Duct Ligation and Postoperative Weight Loss in Obese Patients Undergoing Minimally Invasive Lung Surgery: A Pilot Exploratory Clinical Study

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 29, 2025
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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