Intravenous NTG to Preserve Gastric Microcirculation During Gastric Tube Reconstruction

This study has been completed.

Sponsor:

Information provided by:

Erasmus Medical Center

ClinicalTrials.gov Identifier:

NCT00335010

First received: June 7, 2006

Last updated: NA

Last verified: June 2006

History: No changes posted

Tracking Information

First Received Date ^ICMJE

June 7, 2006

Last Updated Date

June 7, 2006

Start Date ^ICMJE

May 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

differences in Microvascular bloodflow
differences in microvascular hemoglobinsaturation

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

differences in anastomotic leakage
differences in anastomotic stenosis

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Intravenous NTG to Preserve Gastric Microcirculation During Gastric Tube Reconstruction

Official Title ^ICMJE

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention

Condition ^ICMJE

Esophageal Neoplasms
Microcirculation

Intervention ^ICMJE

Drug: Nitroglycerin

Study Arms

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Estimated Completion Date

December 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

younger than 18

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Netherlands

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00335010

Other Study ID Numbers ^ICMJE

MEC-2004-160

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Erasmus Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

PRS Account

Erasmus Medical Center

Verification Date

June 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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