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

Gastric Cancer Clinical Trial

— iGreenGO  

Official title:

[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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04943484
• Other study ID #: 380-09062021
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: November 30, 2024

Study information

• Verified date: May 2024
• Source: Niguarda Hospital
• Contact: Pietro M Lombardi, MD
• Phone: +39026444
• Email: pietrom.lombardi[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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: an international, prospective, multicentre, study.

Study population will be a cohort of western patients who will undergo preoperative upper gastrointestinal endoscopy at the most 20 hours before surgery (intraoperative endoscopic injection before starting surgical dissection is also allowed) 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". Secondary endpoints will be the preoperative clinical variables potentially associated with CSC, the pattern of abdominal fluorescence distribution according to tumor and patient characteristics, the number of additional lymph nodes retrieved using NIR/ICG technology, the incidence of stage migration due to NIR/ICG application, 90-day morbidity and mortality 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 abdominal fluorescence distribution according to tumor and patient characteristics, which are unanswered questions at present time.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: November 30, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 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

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Italy	ASST GOM Niguarda	Milano	Italia

Sponsors (1)

Lead Sponsor	Collaborator
Niguarda Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Nodal fluorescence distribution	Pattern of nodal fluorescence distribution according to tumor and patient characteristics	During surgical intervention (hours)
Secondary	Clinical variables associated with change of the surgical conduct	Identification of preoperative clinical variables potentially associated with change of the surgical conduct	During surgical intervention (hours)