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

Overview

The aim of the iGreenGO Study is to investigate whether the intraoperative application of NIR/ICG technology is associated with a change of the surgical conduct (CSC) during curative-intent gastrectomy with D2 lymphadenectomy in a cohort of western patients affected by gastric cancer. The patterns of ICG fluorescence distribution to the abdominal lymph node stations were also investigated, together with identification of preoperative clinical variables potentially associated with CSC.

Full Title of Study: “[The iGreenGO Study]. Investigation About the Clinical Value of Indocyanine Green Imaging Fluorescence (NIR/ICG) Technology as a Modifier of Surgeon’s Conduct During Curative Treatment of Advanced Gastric Cancer. Study Protocol for a Western, Observational, Prospective, Multicentric Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 31, 2024

Detailed Description

Near infra-red/ indocyanine green imaging fluorescence (NIR/ICG) technology is showing promising results in several fields of surgical oncology. The clinical value of NIR/ICG (near infrared range/indocyanine green) technology in surgical treatment of advanced gastric cancer (AGC) is not clearly established and data regarding whether its application is associated with a change of the intraoperative surgical conduct are lacking in literature. This is the "iGreenGO (indocyanine Green Gastric Observation) Study" protocol: a national, prospective, multicentre, study. Study population will be a cohort of western patients who will undergo preoperative upper gastrointestinal endoscopy the day before surgery with submucosal peritumoral ICG injection and curative-intent gastrectomy with D2 lymphadenectomy for locally AGC. The primary endpoint will be the 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". Key secondary endpoints will be the pattern of nodal fluorescence distribution according to tumor and patient characteristics and identification of preoperative clinical variables potentially associated with CSC. The iGreenGO Study will be the first Western study to investigate the clinical role of NIR/ICG technology for surgical treatment of AGC in a large cohort of western patients. Results from the present study could provide novel information about which help NIR/ICG technology can supply to surgeons during lymphadenectomy for AGC and the patterns of ICG fluorescence distribution to the abdominal lymph node stations according to tumor and patient characteristics, which are unanswered questions at present time.

Interventions

  • Procedure: imaging fluorescence NIR/ICG
    • 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.

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Surgical conduct
    • Time Frame: During surgical intervention (hours)
    • 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”

Secondary Measures

  • Nodal fluorescence distribution
    • Time Frame: During surgical intervention (hours)
    • Pattern of nodal fluorescence distribution according to tumor and patient characteristics
  • Clinical variables associated with change of the surgical conduct
    • Time Frame: During surgical intervention (hours)
    • Identification of preoperative clinical variables potentially associated with change of the surgical conduct

Participating in This Clinical Trial

Inclusion criteria

  • 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, either as first treatment or after preoperative neoadjuvant treatment. – No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative and intraoperative examinations – Written informed consent Exclusion criteria – 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Niguarda Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Giovanni Ferrari, MD, Study Director, Division of Minimally Invasive Surgical Oncology, Niguarda Cancer Center, ASST Grande Ospedale Metropolitano Niguarda
  • Overall Contact(s)
    • Michele Mazzola, MD, +39026444, michele.mazzola@ospedaleniguarda.it

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.