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Not yet recruitingNCT06995599Updated May 29, 2025

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

An interventional study of Thoracic Duct Ligation (TDL) in Obese Patients, sponsored by Yongxin Zhou. Not yet recruiting. Open to participants aged 18 Days to 75 Days. Per ClinicalTrials.gov, last updated 2025-05-29.

Sponsored by Yongxin Zhou · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
18 Days to 75 Days
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Obese Patients

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Keywords

  • Obesity
  • therapy
  • Metabolic Effects of Thoracic Duct Ligation
03

In context

Obesity

6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's planned enrollment of 16 is below the median of 77 across 5,084 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Yongxin Zhou is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Days to 75 Days
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (estimated)

Study arms

  • Experimental
    Thoracic Duct Ligation (TDL)

    Procedure: Thoracic Duct Ligation (TDL)

Interventions

  • ProcedureThoracic 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.

06

What researchers measure

Primary outcomes

  1. Height and weight (for BMI calculation)

    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 .

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2025; primary completion for Dec 2027, 30 months later.

Of 2,253 non-industry interventional studies with no phase under Obesity, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 50. This study's planned 30 months is above that.

Counting every sponsor, half of 2,351 studies reached it within 26 months; a quarter within 11 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 2, 2025
First posted
May 29, 2025
StartEst.
Jun 1, 2025
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2027
Last update
May 29, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06995599
Lead sponsor
Yongxin Zhou
Responsible party
Yongxin Zhou (Chief Surgeon, Department of Thoracic Surgery, Shanghai Tongji Hospital, Tongji University School of Medicine) — Sponsor-investigator
First posted
May 29, 2025
Start date
Jun 1, 2025 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
May 29, 2025

Study contacts

YongXin Zhou
Contact
zhou6302@tongji.edu.cn
021 13681666828

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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