Intravenous NTG to Preserve Gastric Microcirculation During Gastric Tube Reconstruction

Sponsor
Erasmus Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00335010
Collaborator
(none)
32
1
7
4.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
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
Study Start Date :
May 1, 2005
Study Completion Date :
Dec 1, 2005

Outcome Measures

Primary Outcome Measures

  1. differences in Microvascular bloodflow []

  2. differences in microvascular hemoglobinsaturation []

Secondary Outcome Measures

  1. differences in anastomotic leakage []

  2. differences in anastomotic stenosis []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Planned esophagectomy with gastric tube reconstruction

  • written informed consent

  • ASA I and II

Exclusion Criteria:
  • younger than 18

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00335010
Other Study ID Numbers:
  • MEC-2004-160
First Posted:
Jun 8, 2006
Last Update Posted:
Jun 8, 2006
Last Verified:
Jun 1, 2006

Study Results

No Results Posted as of Jun 8, 2006