Using indocyanine green to improve lymph node removal in gastric cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and effectiveness of indocyanine green (ICG) in enhancing lymph node dissection during surgery for resectable gastric cancer. Patients will receive an endoscopic injection of ICG prior to surgery, which will help identify lymph nodes more effectively during the procedure. The primary goal is to assess the average number of lymph nodes removed, while secondary outcomes include the identification of ICG-positive lymph nodes and monitoring for postoperative complications. All eligible patients will undergo total or subtotal gastrectomy with varying degrees of lymphadenectomy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Tumor spread: cT2-4a cN0-3,
* cM0;
* Age: 18 - 80;
* Gender: men and women;
* ECOG: 0 - 1;
* Histologic type of tumor: Adenocarcinoma of any subtype;
* Degree of differentiation: G1 - G4;
* Tumor localization: cardiac region, stomach floor, stomach body, antrum, pylorus, and pyloric region of the stomach;
* Tumor spread: absence of tumor invasion into adjacent structures;
* No history of cancer in the last 5 years;
* No previous chemotherapy, surgery or radiation treatment for another cancer (except for neoadjuvant chemotherapy for gastric cancer);
* Absence of severe comorbidity restricting laparoscopic approach.

Exclusion Criteria:

* M1 (distant metastases);
* ECOG 2 - 4;
* Age over 80 and under 18;
* Presence of severe comorbidities, ASA\> 3;
* Patient refusal to participate in the study.

Where it's running

• National Cancer Institute
  Kyiv, Ukraine Recruiting
• National Cancer Institute
  Kyiv, Ukraine Not yet recruiting

Study contacts

• Study coordinator: Oleksii Dobrzhanskyi, MD
• Email: oleksii.dobrzhanskyi@unci.org.ua
• Phone: +380638760185

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.