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Intravenous NTG to Preserve Gastric Microcirculation During Gastric Tube Reconstruction

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ClinicalTrials.gov Identifier: NCT00335010
Recruitment Status : Completed
First Posted : June 8, 2006
Last Update Posted : June 8, 2006
Sponsor:
Information provided by:
Erasmus Medical Center

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
Esophageal Neoplasms Microcirculation Drug: Nitroglycerin Not Applicable

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 : Interventional  (Clinical Trial)
Enrollment : 32 participants
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 2005
Study Completion Date : December 2005

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U.S. FDA Resources




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


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
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
First Posted: June 8, 2006    Key Record Dates
Last Update Posted: June 8, 2006
Last Verified: June 2006

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

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Nitroglycerin
Vasodilator Agents