Indocyanine Green-guided Omental Shield Anastomosis for Cervical Esophagogastric Anastomosis in Minimally Invasive McKeown Esophagectomy

Официальное название

Indocyanine Green-guided Omental Shield Anastomosis (ICG-OSA) for Cervical Esophagogastric Anastomosis in Minimally Invasive McKeown Esophagectomy: a Single-center, Single-arm, Open-label Clinical Study

Обзор

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.

Вмешательства

• Процедура Indocyanine 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

Первичные конечные точки

• Anastomotic leakage rate within 30 days postoperatively [Срок оценки: Up to 30 days postoperatively (critical assessment window: postoperative day 7±1）]

Вторичные конечные точки (4)

• Subclinical anastomotic leakage rate [Срок оценки: Daily through postoperative day 30]
• Postoperative anastomotic stenosis rate [Срок оценки: 6 months postoperatively]
• Anastomotic leakage-related complication rate [Срок оценки: Up to 30 days postoperatively]
• Health economic indicators [Срок оценки: From hospital admission through hospital discharge, an average of 10 days]

Критерии участия

Критерии включения

• Age 18 to 80 years, of both sexes;
• Pathological diagnosis: Histologically confirmed esophageal squamous cell carcinoma (ESCC) by biopsy;
• 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.

Критерии исключения

• Allergy history: History of allergy to indocyanine green (ICG), iodide, or iodinated contrast agents (ICG contains iodine, and allergy may cause severe anaphylactic reactions);
• 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;
• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Army Medical Center of the People's Liberation Army — Чунцин

Идентификаторы

NCT: NCT07376876 · ICG-OSA for anastomosis · 0

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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