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

January 26, 2026 updated by: WEI GUO, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

73

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: xiandong he doctor
  • Phone Number: +86 15528320608
  • Email: 576875034@qq.com

Study Locations

  • China
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400042
        • Army Medical Center of the People's Liberation Army

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Indocyanine Green-Guided Omental Shield Anastomosis (ICG-OSA) Intervention Group
Procedure: 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anastomotic leakage rate within 30 days postoperatively
Time Frame: 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.
Up to 30 days postoperatively (critical assessment window: postoperative day 7±1）

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subclinical anastomotic leakage rate
Time Frame: 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.
Daily through postoperative day 30
Postoperative anastomotic stenosis rate
Time Frame: 6 months postoperatively
Anastomotic stricture rate diagnosed by endoscopy and dysphagia symptoms.
6 months postoperatively
Anastomotic leakage-related complication rate
Time Frame: 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.
Up to 30 days postoperatively
Health economic indicators
Time Frame: 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).
From hospital admission through hospital discharge, an average of 10 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technique-related adverse events
Time Frame: From intraoperative period through 30 days postoperatively
  1. ICG-related reactions: Allergic reactions (rash, anaphylaxis).
  2. Gastric conduit complications: Ischemia/necrosis of gastric tube, gastric emptying disorder, staple line bleeding.
  3. Omental flap complications: Omental necrosis, poor wound healing at omental harvest site.
  4. Anastomotic technical issues: Stapler misfire, anastomotic bleeding requiring intervention.
From intraoperative period through 30 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 2, 2026

First Submitted That Met QC Criteria

January 26, 2026

First Posted (Actual)

January 29, 2026

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICG-OSA for anastomosis
  • Other Grant/Funding Number: Community Foundation of Greater Birmingham Women's Breast Health Fund

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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