drugset / Trial / NCT05354856

The Effect of Chemoradiotherapy on Gastric Perfusion in Patients With Gastric Cancer.

NCT05354856

Phase 4 Terminated 11 enrolled Rigshospitalet, Denmark
NaSingle-groupOpen-labelDiagnostic

Summary

A study from our group (Osterkamp et al. in preparation) used ICG to evaluate intraoperative changes in gastric perfusion when reducing the circulating blood volume by blood withdrawal in pigs. We saw a significant reduction in gastric perfusion with decreased blood volume, and this reduction of gastric perfusion was detectable with ICG. As data from a previous trial (PRESET phase 2 Protocol nr: H-15014904) has shown that chemotherapy decreases the circulating red blood cell volume in patients with gastroesophageal cancer, we wish to evaluate if standard care neoadjuvant chemotherapy also influences gastric perfusion. Gastric perfusion will be assessed during a screening laparoscopy (before chemotherapy) and then compared with a second assessment during gastric resection (after chemotherapy). The gastric perfusion will be measured using fluorescence-guided surgery with Indocyanine Green. Participants will be offered the opportunity to have their blood volume measured during the trial. This is not required in order to take part in the fluorescence angiography part of the study.

Timeline

Start
2022-03-11
Primary completion
2023-12-29
Completion
2023-12-30

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Indocyanine Green Diagnostic / imaging agent 0.1 mg/kg Intravenous
Subject Indocyanine Green Diagnostic / imaging agent 0.2 mg/kg Intravenous

Indications