Thoracic Duct Ligation and Postoperative Weight Loss in Obese Patients Undergoing Minimally Invasive Lung Surgery: A Pilot Exploratory Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 16
- 主要终点
- Height and weight (for BMI calculation)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Days 至 75 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
研究组 & 干预措施
Thoracic Duct Ligation (TDL)
干预措施: Thoracic Duct Ligation (TDL) (Procedure)
结局指标
主要结局
Height and weight (for BMI calculation)
时间窗: 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)
次要结局
未报告次要终点
研究者
Yongxin Zhou
Chief Surgeon, Department of Thoracic Surgery
Shanghai Tongji Hospital, Tongji University School of Medicine