Near-infrared Imaging With Indocyanine Green for Detection of Peritoneal Metastases for Gastric Adenocarcinoma.
Reason given: Recruitment lower than expected and negative results.
Key facts
- Where
- Montreal and Québec, CanadaSee the 2 sites
- Phase
- Phase 2
Where in Canada
- CIUSSS de l'Est-de-l'Île-de-MontréalMontreal, CanadaNo longer taking part
- CHU de QuebecQuébec, CanadaNo longer taking part
Trial details
- Who runs it
- Laval University
- Trial code
- NCT05687617
- Record updated
- 2 April 2024
- Original description
Peritoneal disease at initial presentation for patients with gastric adenocarcinoma (GA) is frequent, with 15-31% of patients presenting with peritoneal metastases (PM) at surgical exploration. The prognosis of patients with PM is poor, overall survival (OS) ranging from 8 to 13 months, reinforcing the importance of optimal patient selection before surgical management of GA.Read full original descriptionShow less
Diagnostic Value of Intraoperative Near-infrared Imaging With Indocyanine Green for Detection of Peritoneal Metastases During Staging Laparoscopy for Gastric Adenocarcinoma: a Prospective, Multicentric Study.
Peritoneal disease at initial presentation for patients with gastric adenocarcinoma (GA) is frequent, with 15-31% of patients presenting with peritoneal metastases (PM) at surgical exploration. The prognosis of patients with PM is poor, overall survival (OS) ranging from 8 to 13 months, reinforcing the importance of optimal patient selection before surgical management of GA.
Indocyanine Green (ICG) fluorescence imaging for intraoperative detection of PM has been described in recent literature as a useful tool in patients undergoing cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) for peritoneal malignancies to increase the detection of PM during surgery. However, the role of ICG for patients with GA, and its role during diagnosic laparoscopy (DL), remain unknown.
Inclusion: Confirmed diagnosis of gastric adenocarcinoma; Clinical stage cT2 or higher; No evidence of metastatic disease on preoperative imaging; Patient fit for surgery (ECOG 0 or 1).
Exclusion: Patient unfit for surgery (ECOG 2 or more); Indocyanine allergy; Gastric cancer subtype other than gastric adenocarcinoma; Evidence of metastatic disease on preoperative imaging; Unconfirmed diagnosis of gastric adenocarcinoma (unable to confirm diagnosis); Clinical stage cT1b or lower.