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AzTrials

Esophageal Squamous Cell Carcinoma (ESCC)Phase 2NCT07376876

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

A Phase 2 study testing Indocyanine green-guided omental shield anastomosis for cervical esophagogastric anastomosis in people with Esophageal Squamous Cell Carcinoma (ESCC) and Esophageal Cancer, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Indocyanine green-guided omental shield anastomosis for cervical esophagogastric anastomosis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
1 siteChina
Study dates
1 Jan 2026to 31 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

xiandong he doctor contact

+86 15528320608

576875034@qq.com

China1 site

  • Army Medical Center of the People's Liberation Army

    Chongqing, Chongqing Municipality, 400042

Other trials in China

About this study

Official title: 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.

Read more

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.

Being tested
Indocyanine green-guided omental shield anastomosis for cervical esophagogastric anastomosis
Keywords
Indocyanine Green Fluorescence Navigation, Anastomotic Leakage, Omental Shield, Esophageal Squamous Cell Carcinoma (ESCC)
Medical subject headings
Esophageal Squamous Cell Carcinoma, Esophageal Neoplasms, Anastomotic Leak

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Indocyanine green-guided omental shield anastomosis for cervical esophagogastric anastomosisProcedure or surgery

    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.

Study groups in NCT07376876
Study groupRoleWhat they receive
Indocyanine Green-Guided Omental Shield Anastomosis (ICG-OSA) Intervention GroupExperimentalNot described
Receives: Procedure: Indocyanine green-guided omental shield anastomosis for cervical esophagogastric anastomosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 30 days postoperatively (critical assessment window: postoperative day 7±1）

Secondary outcomes (4)

  1. 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.

    Measured: Daily through postoperative day 30

  2. Postoperative anastomotic stenosis rate

    Anastomotic stricture rate diagnosed by endoscopy and dysphagia symptoms.

    Measured: 6 months postoperatively

  3. 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.

    Measured: Up to 30 days postoperatively

  4. 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).

    Measured: From hospital admission through hospital discharge, an average of 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2026
  2. Study start1 Jan 2026 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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.
Masking
None (open label)
Enrolment
73 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07376876
Sponsor's protocol ID
ICG-OSA for anastomosis
Other IDs
0
Status last verified
Jan 2026
First submitted
2 Jan 2026
Last updated
29 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Indocyanine green-guided omental shield anastomosis for cervical esophagogastric anastomosis in people with Esophageal Squamous Cell Carcinoma (ESCC) and Esophageal Cancer, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact xiandong he doctor (+86 15528320608, 576875034@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anastomotic leakage rate within 30 days postoperatively (time frame: Up to 30 days postoperatively (critical assessment window: postoperative day 7±1）). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07376876.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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