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

June 7, 2006
June 7, 2006
May 2005
Not Provided
  • differences in Microvascular bloodflow
  • differences in microvascular hemoglobinsaturation
Same as current
No Changes Posted
  • differences in anastomotic leakage
  • differences in anastomotic stenosis
Same as current
Not Provided
Not Provided
 
Intravenous NTG to Preserve Gastric Microcirculation During Gastric Tube Reconstruction
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Esophageal Neoplasms
  • Microcirculation
Drug: Nitroglycerin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
December 2005
Not Provided

Inclusion Criteria:

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

Exclusion Criteria:

  • younger than 18
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00335010
MEC-2004-160
Not Provided
Not Provided
Erasmus Medical Center
Not Provided
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
Erasmus Medical Center
June 2006

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