Esophageal Cancer, Esophageal Squamous Cell Carcinoma (ESCC)
Conditions
Keywords
Indocyanine Green Fluorescence Navigation, Anastomotic Leakage, Omental Shield, Esophageal Squamous Cell Carcinoma (ESCC)
Brief 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.
Interventions
PROCEDUREIndocyanine green-guided omental shield anastomosis for cervical esophagogastric anastomosis
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.
Sponsors
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18 to 80 years, of both sexes; 2. Pathological diagnosis: Histologically confirmed esophageal squamous cell carcinoma (ESCC) by biopsy; 3. 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; 4. Performance status ECOG 0-1； 5. Major organ function (cardiovascular, respiratory, digestive, hematological systems) assessed as having no contraindications for chemotherapy or immunotherapy, and no surgical contraindications; 6. Able to understand and comply with study protocol requirements, and willing to accept and undergo standardized postoperative follow-up; 7. Able to understand and sign the informed consent form.
Exclusion criteria
1. Allergy history: History of allergy to indocyanine green (ICG), iodide, or iodinated contrast agents (ICG contains iodine, and allergy may cause severe anaphylactic reactions); 2. 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; 3. 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; 4. Previous surgery history: Prior history of esophageal, gastric, or mediastinal surgery resulting in altered anatomy or severe adhesions; 5. Multiple primary cancers: Concurrent active malignant tumors in other sites (except cured basal cell carcinoma of the skin or cervical carcinoma in situ); 6. Special physiological status: Pregnant or lactating women, or those with planned pregnancy during the study period who are unwilling to use effective contraception; 7. Cognitive and behavioral issues: Presence of severe psychiatric illness, cognitive impairment, or history of substance abuse that would preclude compliance with study procedures; 8. Participation in other studies: Currently enrolled in other interventional clinical trials that may interfere with the results of this study; 9. 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anastomotic leakage rate within 30 days postoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health economic indicators | From hospital admission through hospital discharge, an average of 10 days | 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). |
| Subclinical anastomotic leakage rate | Daily through postoperative day 30 | 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. |
| Postoperative anastomotic stenosis rate | 6 months postoperatively | Anastomotic stricture rate diagnosed by endoscopy and dysphagia symptoms. |
| Anastomotic leakage-related complication rate | Up to 30 days postoperatively | 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. |
Countries
China
Contacts
CONTACTxiandong he doctor
Outcome results
None listed