NCT06755554

Brief Summary

The study aims to evaluate the safety and benefits of using indocyanine green in lymph node dissection for gastric cancer surgery. The primary endpoint is the average number of lymph nodes removed. Secondary study points are the average number of ICG-positive lymph nodes; the average number of metastatic ICG-positive lymph nodes; the number of postoperative complications and complications associated with the administration of ICG. Patients who meet the inclusion criteria for this study will be enrolled in the study after reviewing and signing an informed consent form. All patients will be included in one group and will receive surgical treatment in the amount of total or subtotal gastrectomy with lymphadenectomy D1, D1+, D2 or D2+. ICG is injected by the patient by endoscopic submucosal injection into 4 points around the tumor 24-12 hours before the start of the surgical intervention. Assessment of the number of fluorescent lymph nodes will be performed intraoperatively with their subsequent removal and mapping. The incidence of postoperative complications will be assessed by Clavien-Dindo.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
105

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2025

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 24, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 1, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

1 year

First QC Date

December 24, 2024

Last Update Submit

March 25, 2025

Conditions

Gastric Cancer Stage IIGastric Cancer Stage IIIGastric CancerGastrectomy for Gastric Cancer

Keywords

indocyanine greengastric cancergastrectomy

Outcome Measures

Primary Outcomes (1)

  • Investigation of the average number of lymph nodes removed during lymph node dissection using indocyanine green

    30 days after surgery

Secondary Outcomes (2)

  • Average number of metastatic ICG-positive lymph nodes

    30 days after surgery

  • Number of postoperative complications and complications associated with the introduction of ICG.

    90 days after surgery

Study Arms (1)

Indocyanine green mapping

EXPERIMENTAL

Endoscopic injection of indocyanine green is performed under general anesthesia. Indocyanine green is injected into the submucosal layer of the stomach at 4 points around the tumor. The dosage for one administration is up to 5 mg. The total dosage for one patient for 4 doses is 20 mg. Monitoring of indocyanine green side effects occurs before the start of general anesthesia during radical surgery.

Drug: Endoscopic injection of Indocyanine green

Interventions

Endoscopic injection of Indocyanine greenDRUG

ICG is injected by the patient by endoscopic submucosal injection into 4 points around the tumor 24-12 hours before the start of the surgical intervention.

Indocyanine green mapping

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Cancer Institute

Kyiv, 03022, Ukraine

NOT YET RECRUITING

National Cancer Institute

Kyiv, 03022, Ukraine

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Central Study Contacts

Oleksii Dobrzhanskyi, MD

CONTACT

+380638760185oleksii.dobrzhanskyi@unci.org.ua

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

December 24, 2024

First Posted

January 1, 2025

Study Start

January 1, 2025

Primary Completion

January 1, 2026

Study Completion

February 1, 2026

Last Updated

March 30, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Available by request

Locations

UA(2)