Indocyanine Green-guided Omental Shield Anastomosis (ICG-OSA) for Cervical Esophagogastric Anastomosis in Minimally Invasive McKeown Esophagectomy: a Single-center, Single-arm, Open-label Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Anastomotic leakage rate within 30 days postoperatively
研究概览
简要总结
Brief Summary Study title: Indocyanine green (ICG)-guided omental shield anastomosis (ICG-OSA) technique for cervical esophagogastric anastomosis in esophageal cancer surgery Purpose: To evaluate whether a novel surgical technique can reduce the risk of anastomotic leakage after minimally invasive esophageal cancer surgery.
Eligible participants: Adults aged 18-80 years with histologically confirmed esophageal squamous cell carcinoma (ESCC) in the middle or lower thoracic esophagus who are scheduled for esophagectomy.
The technique: All participants will undergo the ICG-OSA procedure, which uses indocyanine green fluorescence imaging to assess gastric perfusion, creates a T-shaped esophagogastric anastomosis, and wraps the anastomosis with a pedicled omental flap.
Outcome assessments: The primary outcome is anastomotic leakage rate within 30 days after surgery. Secondary assessments include surgical site infection, anastomotic stricture, and hospitalization costs.
Study site: Daping Hospital, Army Medical Center, Chongqing, China Study duration: December 2025 to March 2027 Contact: For more information, please contact the research team at Daping hospital.
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 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 80 years, of both sexes;
- •Pathological diagnosis: Histologically confirmed esophageal squamous cell carcinoma (ESCC) by biopsy;
- •Clinical staging: Preoperative clinical stage cT1-4aN0-3M0 (according to the 8th edition AJCC staging criteria), evaluated by the thoracic surgery team as eligible for radical McKeown esophagectomy;
- •Performance status ECOG 0-1；
- •Major organ function (cardiovascular, respiratory, digestive, hematological systems) assessed as having no contraindications for chemotherapy or immunotherapy, and no surgical contraindications;
- •Able to understand and comply with study protocol requirements, and willing to accept and undergo standardized postoperative follow-up;
- •Able to understand and sign the informed consent form.
排除标准
- •Allergy history: History of allergy to indocyanine green (ICG), iodide, or iodinated contrast agents (ICG contains iodine, and allergy may cause severe anaphylactic reactions);
- •Severe hepatic or renal dysfunction: Severe hepatic insufficiency (Child-Pugh Class C) or severe renal insufficiency (eGFR <30 mL/min/1.73 m²), affecting ICG metabolism and excretion;
- •Unfavorable tumor location: Tumor located in the cervical or upper thoracic esophagus (<25 cm from the incisors), making it difficult to ensure negative proximal resection margin;
- •Previous surgery history: Prior history of esophageal, gastric, or mediastinal surgery resulting in altered anatomy or severe adhesions;
- •Multiple primary cancers: Concurrent active malignant tumors in other sites (except cured basal cell carcinoma of the skin or cervical carcinoma in situ);
- •Special physiological status: Pregnant or lactating women, or those with planned pregnancy during the study period who are unwilling to use effective contraception;
- •Cognitive and behavioral issues: Presence of severe psychiatric illness, cognitive impairment, or history of substance abuse that would preclude compliance with study procedures;
- •Participation in other studies: Currently enrolled in other interventional clinical trials that may interfere with the results of this study;
- •Investigator judgment: Investigator considers the patient unsuitable for this clinical study (e.g., intraoperative exploration reveals severe tumor invasion of major structures such as the aorta or trachea, making R0 resection unachievable).
研究组 & 干预措施
Indocyanine Green-Guided Omental Shield Anastomosis (ICG-OSA) Intervention Group
干预措施: Indocyanine green-guided omental shield anastomosis for cervical esophagogastric anastomosis (Procedure)
结局指标
主要结局
Anastomotic leakage rate within 30 days postoperatively
时间窗: Up to 30 days postoperatively (critical assessment window: postoperative day 7±1）
Anastomotic leakage rate assessed by clinical evaluation, computed tomography (CT) scan with oral contrast, and endoscopy according to ECCG criteria.
次要结局
- Subclinical anastomotic leakage rate(Daily through postoperative day 30)
- Postoperative anastomotic stenosis rate(6 months postoperatively)
- Anastomotic leakage-related complication rate(Up to 30 days postoperatively)
- Health economic indicators(From hospital admission through hospital discharge, an average of 10 days)
研究者
WEI GUO
director
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University