Intravenous NTG to Preserve Gastric Microcirculation During Gastric Tube Reconstruction - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 7, 2006

Last Updated Date

June 7, 2006

Start Date ^†

May 2005

Current Primary Outcome Measures ^†

differences in Microvascular bloodflow
differences in microvascular hemoglobinsaturation

Original Primary Outcome Measures ^†

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^†

differences in anastomotic leakage
differences in anastomotic stenosis

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

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

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.

Study Phase

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^†

Esophageal Neoplasms
Microcirculation

Intervention ^†

Drug: Nitroglycerin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

December 2005

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Planned esophagectomy with gastric tube reconstruction
written informed consent
ASA I and II

Exclusion Criteria:

younger than 18

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Netherlands

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00335010

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Erasmus Medical Center

Collaborators ^††

Investigators ^†

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

Information Provided By

Erasmus Medical Center

Verification Date

June 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.