The Effect of Chemoradiotherapy on Gastric Perfusion in Patients With Gastric Cancer.
Reason given: recruiting issues
Key facts
- Where
- Copenhagen, DenmarkSee the site
- Phase
- Phase 4
Where in Denmark
- RigshospitaletCopenhagen, DenmarkNo longer taking part
Trial details
- Who runs it
- Copenhagen University Hospital, Rigshospitalet
- Trial code
- NCT05354856
- Record updated
- 2 May 2024
- Original description
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.Read full original descriptionShow less
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.
Inclusion: Patients (above 18 years) scheduled for planned open or robot-assisted resection of gastric cancer.
Exclusion: Allergy towards; iodine, indocyanine green or shellfish; Severe liver insufficiency; Disseminated disease or other that contraindicates curative surgery; Thyrotoxicosis; Nephropathy requiring dialysis; Pregnancy or lactation; Legally incompetent for any reason; Withdrawal of inclusion consent.