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

• Status: Recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark

Criteria

Inclusion Criteria:

• Patients (above 18 years) scheduled for planned open or robot-assisted resection of gastric cancer.

Exclusion Criteria:

• Allergy towards; iodine, indocyanine green or shellfish

• Severe liver insufficiency

• Thyrotoxicosis

• Nephropathy requiring dialysis

• Pregnancy or lactation

• Legally incompetent for any reason

• Withdrawal of inclusion consent

• Disseminated disease or other that contraindicates curative surgery