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Spots Global Cancer Trial Database for Intravenous NTG to Preserve Gastric Microcirculation During Gastric Tube Reconstruction

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Trial Identification

Brief Title: Intravenous NTG to Preserve Gastric Microcirculation During Gastric Tube Reconstruction

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

Study ID: NCT00335010

Interventions

Nitroglycerin

Study Description

Brief Summary: The aim of the present study was to investigate if NTG, administered intravenously during gastric tube reconstruction, could preserve gastric fundus tissue blood flow and oxygenation and reduce the incidence of postoperative leakage.

Detailed Description: 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Erasmus MC, Rotterdam, , Netherlands

Contact Details

Name: Diederik Gommers, MD, PhD

Affiliation: Erasmus Medical Center

Role: STUDY_CHAIR

Name: Marc Buise, MD

Affiliation: Erasmus Medical Center

Role: PRINCIPAL_INVESTIGATOR

Name: Jasper van Bommel, MD, PhD

Affiliation: Erasmus Medical Center

Role: STUDY_DIRECTOR

Name: Huug Tilanus, MD, PhD

Affiliation: Erasmus Medical Center

Role: PRINCIPAL_INVESTIGATOR

Name: Khe Tran, MD

Affiliation: Erasmus Medical Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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