ICG (Indocyanine Green) Imaging Fluorescence Technology in Surgical Treatment of Advanced Gastric Cancer

NCT04943484 | Recruiting

• 1 other identifier: 380-09062021
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

The iGreenGO Study aims to investigate whether the intraoperative application of NIR/ICG technology is associated with a change in the surgical conduct (CSC) during curative-intent gastrectomy with D2 lymphadenectomy in a cohort of Western patients affected by AGC. The preoperative clinical variables potentially associated with CSC will be also investigated

Conditions

Gastric Cancer

Keywords

advanced; gastric cancer; indocyanine green; ICG; surgery; D2 lymphadenectomy; surgical conduct

Outcome Measures

Primary Outcomes (1)

• Surgical conduct

  Incidence of "change of the surgical conduct" (CSC) at the moment of intraoperative NIR/ICG technology activation after a D2 lymphadenectomy performed "with the naked eye"

  During surgical intervention (hours)

Secondary Outcomes (2)

• Nodal fluorescence distribution

  During surgical intervention (hours)

• Clinical variables associated with change of the surgical conduct

  During surgical intervention (hours)

Study Arms (1)

Gastric cancer

Male and female subjects, over 18 years of age, with histological diagnosis of locally advanced gastric carcinoma (AGC), surgically resectable, without evidence of distant metastases (cT2-T4a; N0-3; M0) for which a surgical intervention with curative purposes is indicated both as a first treatment and following preoperative neoadjuvant chemotherapy

Procedure: imaging fluorescence NIR/ICG

Interventions

imaging fluorescence NIR/ICG PROCEDURE

Preoperative upper GI endoscopy (UGE) UGE with submucosal injection of 2ml of ICG 0.125mg/ml solution to four peritumoral sites 15-20 hours before surgery Surgery D2 Distal gastrectomy with dissection of 1, 3, 4sb, 4sd, 5, 6, 7, 8a, 9, 11p, 12a lymph node stations (LNS) D2 Total gastrectomy with dissection of 1, 2, 3, 4sa, 4sb, 4d, 5, 6, 7, 8a, 9, 11p, 11d, 12a LNS Intraoperative NIR/ICG technology, "change of surgical conduct" (CSC) A visualization of the operative field (OF) with NIR/ICG technology is performed at the beginning of surgery and before to dissect each LNS. Subsequently, surgery is performed "with the naked eye". At the end, a visualization of the OF is performed using NIR/ICG technology to verify whether residual lymph nodes in each D2 nodal station exist. CSC is defined as the occurring of the following situation: in case of persistence of nodal fluorescence in D2 nodal stations, the completion of the dissection of the residual nodal fluorescent structures.

Also known as: indocyanine green

Gastric cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female subjects, over 18 years of age, with histological diagnosis of locally advanced gastric carcinoma (AGC), surgically resectable, without evidence of distant metastases (cT2-T4a; N0-3; M0) for which a surgical intervention with curative purposes is indicated both as a first treatment and following preoperative neoadjuvant chemotherapy

You may qualify if:

• Age ≥ 18 years old
• Preoperative histologically proven adenocarcinoma of the upper, middle or lower part of the stomach.
• Advanced disease (Staged cT2-T4a, N0-3;M0 according to 8th edition of the AJCC TNM Staging System) at diagnosis, in which resection can be safely achieved by distal or total gastrectomy with D2 lymphadenectomy via a minimally invasive (laparoscopic or robotic) approach, either as first treatment or after neoadjuvant treatment
• No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative and intraoperative examinations
• Written informed consent

You may not qualify if:

• Women during pregnancy or breast-feeding
• History of previous upper abdominal surgery (laparoscopic cholecystectomy will be allowed)
• History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
• History of allergy to iodine agents
• Cancer located at the esophago-gastric junction (Siewert I, II, III tumors 29)
• Patients candidates to transthoracic esophagectomy, transhiatal extended gastrectomy or proximal gastrectomy
• History of previous neoadjuvant chemotherapy (except perioperative chemotherapy for gastric cancer) or radiotherapy

Sponsors & Collaborators

• Niguarda Hospital: lead

Study Sites (1)

ASST GOM Niguarda

Milan, Italia, 20162, Italy

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Pietro M Lombardi, MD

  Division of Minimally Invasive Surgical Oncology, Niguarda Cancer Center, ASST Grande Ospedale Metropolitano Niguarda

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pietro M Lombardi, MD

CONTACT

+39026444; pietrom.lombardi@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: June 29, 2021
• Study Start: January 1, 2022
• Primary Completion: August 31, 2024
• Study Completion (Estimated): November 30, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 4 years
• Access Criteria: Participant centres

Locations

IT (1)