Indocyanine Green-guided Omental Shield Anastomosis for Cervical Esophagogastric Anastomosis in Minimally Invasive McKeown Esophagectomy
- Sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Study ID
- NCT07376876
- Phase
- PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Esophageal Cancer
- Esophageal Squamous Cell Carcinoma (ESCC)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Indocyanine green-guided omental shield anastomosis for cervical esophagogastric anastomosis — PROCEDUREStep 1: ICG-guided gastric conduit prep: IV ICG fluorescence laparoscopy assesses gastroepiploic arcade (Koskas types) and perfusion zones (red=good, blue=poor), marks optimal anastomotic site on greater curvature, optimizes conduit tailoring. Step 2: T-Shaped Stapled Anastomosis\*\*: 1cm opening on posterior greater curvature wall at best perfusion zone, side-to-side stapling of posterior esophagus to greater curvature, closes common opening, reinforces with absorbable sutures. Step 3: Omental Shield: mobilizes pedicled omentum with good blood supply, 360° sleeve-wrap of anastomosis + 2cm area, fixes with 4-6 absorbable sutures to gastric wall above/below, ensures no tension/torsion.
Study Details
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.
Key Dates
- First listed
- Jan 29, 2026
- Start date
- Jan 1, 2026
- Status verified
- Jan 2026
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 73 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Indocyanine Green-Guided Omental Shield Anastomosis (ICG-OSA) Intervention Group
Primary Outcome Measure
Anastomotic leakage rate within 30 days postoperatively [ Time Frame: Up to 30 days postoperatively (critical assessment window: postoperative day 7±1) ]
Central Contacts
- xiandong he doctor+86 15528320608
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