Obese PatientsNCT06995599
Impact of Thoracic Duct Ligation on Postoperative Weight Reduction in Obese Patients Receiving Minimally Invasive Lung Surgery: A Clinical Investigation
A study testing Thoracic Duct Ligation (TDL) in people with Obese Patients, run by Yongxin Zhou.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 days
- Conditions the study is for
- Obese Patients
- What is being tested?
- Thoracic Duct Ligation (TDL)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Thoracic Duct Ligation and Postoperative Weight Loss in Obese Patients Undergoing Minimally Invasive Lung Surgery: A Pilot Exploratory Clinical Study
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.
- Conditions
- Obese Patients
- Being tested
- Thoracic Duct Ligation (TDL)
- Keywords
- Obesity, therapy, Metabolic Effects of Thoracic Duct Ligation
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic Duct Ligation (TDL)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Thoracic Duct Ligation (TDL) | Experimental | Not described Receives: Procedure: Thoracic Duct Ligation (TDL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height and weight (for BMI calculation)
Height and weight (for BMI calculation)
Measured: 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 .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obese PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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).
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yongxin Zhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yongxin Zhou, Shanghai Tongji Hospital, Tongji University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995599
- Sponsor's protocol ID
- Ethics Review No. 2025-003
- Status last verified
- May 2025
- First submitted
- 2 Apr 2025
- Last updated
- 29 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracic Duct Ligation and Postoperative Weight Loss in Obese Patients Undergoing Minimally Invasive Lung Surgery: A Pilot Exploratory Clinical Study
- ClinicalTrials.gov ID
- NCT06995599
- Acronym / sponsor ID
- Ethics Review No. 2025-003
- Conditions
- Obese Patients
- Keywords
- Obesity, therapy, Metabolic Effects of Thoracic Duct Ligation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Yongxin ZhouUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| Thoracic Duct Ligation (TDL) | Experimental | Procedure: Thoracic Duct Ligation (TDL) |
Who may qualify
- Ages
- 18 to 75 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracic 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. | Procedure or surgery | Thoracic Duct Ligation (TDL) |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic Duct Ligation (TDL) in people with Obese Patients, run by Yongxin Zhou.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YongXin Zhou (021 13681666828, zhou6302@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 .). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.