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
  Purpose

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.


Condition Intervention
Esophageal Neoplasms
Microcirculation
Drug: Nitroglycerin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:
  • differences in Microvascular bloodflow
  • differences in microvascular hemoglobinsaturation

Secondary Outcome Measures:
  • differences in anastomotic leakage
  • differences in anastomotic stenosis

Estimated Enrollment: 32
Study Start Date: May 2005
Estimated Study Completion Date: December 2005
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • younger than 18
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00335010

Locations
Netherlands
Erasmus MC
Rotterdam, Netherlands, 3000ZA
Sponsors and Collaborators
Erasmus Medical Center
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00335010     History of Changes
Other Study ID Numbers: MEC-2004-160
Study First Received: June 7, 2006
Last Updated: June 7, 2006
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Erasmus Medical Center:
Nitroglycerine
gastroesophageal anastomosis
microvascular bloodflow
microvascular hemoglobinsaturation

Additional relevant MeSH terms:
Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Nitroglycerin
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014