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| ID | Type | Description | Link |
|---|---|---|---|
| 0 | Other Identifier | Army Medical Center , Army Medical University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indocyanine Green-Guided Omental Shield Anastomosis (ICG-OSA) Intervention Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indocyanine green-guided omental shield anastomosis for cervical esophagogastric anastomosis | Procedure | Step 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Anastomotic leakage rate within 30 days postoperatively | Anastomotic leakage rate assessed by clinical evaluation, computed tomography (CT) scan with oral contrast, and endoscopy according to ECCG criteria. | Up to 30 days postoperatively (critical assessment window: postoperative day 7±1) |
| Measure | Description | Time Frame |
|---|---|---|
| Subclinical anastomotic leakage rate | Turbid mediastinal drainage fluid with positive bacterial culture, but requiring no intervention (i.e., no puncture drainage, stent placement, or surgery); daily recording of drainage fluid characteristics, with positive culture results confirmed by laboratory reports. | Daily through postoperative day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Technique-related adverse events |
| From intraoperative period through 30 days postoperatively |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xiandong he doctor | Contact | +86 15528320608 | 576875034@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Army Medical Center of the People's Liberation Army | Chongqing | Chongqing Municipality | 400042 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Study Protocol and Statistical Analysis Plan |
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Step 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.
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| Postoperative anastomotic stenosis rate | Anastomotic stricture rate diagnosed by endoscopy and dysphagia symptoms. | 6 months postoperatively |
| Anastomotic leakage-related complication rate | Complications directly related to anastomotic leakage, including pulmonary infection, empyema, mediastinal infection, and sepsis. Complications will be graded using the Clavien-Dindo classification system. Diagnosis will be confirmed by clinical symptoms (fever, leukocytosis), microbiological cultures, and imaging findings (CT scan showing fluid collections or air-fluid levels). Each complication will be documented with onset date, severity grade, and required interventions. | Up to 30 days postoperatively |
| Health economic indicators | Total medical costs from hospital admission to discharge, including operation fees, anesthesia, medication, laboratory tests, imaging studies, hospital bed, and other related expenses. Data will be extracted from the hospital information system (HIS) at discharge and recorded in the case report form.Number of days from the date of surgery to hospital discharge, calculated as (discharge date minus surgery date + 1 day). | From hospital admission through hospital discharge, an average of 10 days |
| Dec 2, 2025 |
| Jan 2, 2026 |
| Prot_SAP_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Study Protocol and Statistical Analysis Plan V2 | Dec 2, 2025 | Jan 26, 2026 | Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| D004938 | Esophageal Neoplasms |
| D057868 | Anastomotic Leak |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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