Intravenous NTG to Preserve Gastric Microcirculation During Gastric Tube Reconstruction
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||A Prospective Double Blinded Study on the Effect of Intravenously Administrated Nitroglycerine on Gastric Tissue Microvascular Bloodflow and Microvascular Hemoglobin Saturation During Gastric Tube Reconstruction|
- differences in Microvascular bloodflow
- differences in microvascular hemoglobinsaturation
- differences in anastomotic leakage
- differences in anastomotic stenosis
|Study Start Date:||May 2005|
|Estimated Study Completion Date:||December 2005|
Complications of oesophagectomy and gastric tube reconstruction are leakage and stenosis, which may be due to compromised microvascular blood flow (MBF) in the gastric tissue. We recently demonstrated that peri-operatively decreased MBF could be improved by topical administration of nitro-glycerine NTG). In this present study we investigate the effect of intravenous NTG on gastric microcirculation.
This single centre, prospective, double blinded study randomized thirty-two patients scheduled for esophagectomy into two groups. The intervention group received intravenous NTG during gastric tube reconstruction, as the control group received normal saline.
Baseline values of MBF, microvascular haemoglobin O2 saturation (μHbSO2), and microvascular haemoglobin concentration (μHbcon) were determined at the gastric fundus before and after gastric tube construction and after pulling up the gastric tube to the neck.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00335010
|Rotterdam, Netherlands, 3000ZA|
|Study Chair:||Diederik Gommers, MD, PhD||Erasmus MC|
|Principal Investigator:||Marc Buise, MD||Erasmus MC|
|Study Director:||Jasper van Bommel, MD, PhD||Erasmus MC|
|Principal Investigator:||Huug Tilanus, MD, PhD||Erasmus MC|
|Principal Investigator:||Khe Tran, MD||Erasmus MC|