Esophageal Squamous Cell Carcinoma
Conditions
Interventions
Indocyanine Green-Guided Omental Shield Anastomosis (ICG-OSA) Intervention Group:Indocyanine Green-Guided Omental Shield Anastomosis for Cervical Esophagogastric Anastomosis
Sponsors
Army Medical Center, Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
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
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 m^2), 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 |
|---|---|
| Anastomotic Leakage Rate within 30 Days Postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Subclinical Anastomotic Leakage Rate;Anastomotic Leakage-Related Complication Rate;Technique-Related Adverse Events;Health Economic Indicators; | — |
Countries
China
Contacts
Public ContactWei Guo
Army Medical Center, Army Medical University
Outcome results
None listed