Indocyanine Green-guided Omental Shield Anastomosis for Cervical Esophagogastric Anastomosis in M… (NCT07376876) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Indocyanine Green-guided Omental Shield Anastomosis for Cervical Esophagogastric Anastomosis in Minimally Invasive McKeown Esophagectomy
China73 participantsStarted 2026-01-01
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. 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.
Exclusion criteria
✕. Allergy history: History of allergy to indocyanine green (ICG), iodide, or iodinated contrast agents (ICG contains iodine, and allergy may cause severe anaphylactic reactions);
What they're measuring
1
Anastomotic leakage rate within 30 days postoperatively
Timeframe: Up to 30 days postoperatively (critical assessment window: postoperative day 7±1）
Trial details
NCT IDNCT07376876
SponsorDaping Hospital and the Research Institute of Surgery of the Third Military Medical University
✕. 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;