Intravenous NTG to Preserve Gastric Microcirculation During Gastric Tube Reconstruction - Full Text View

Sponsored by:	Erasmus Medical Center
Information provided by:	Erasmus Medical Center
ClinicalTrials.gov Identifier:	NCT00335010

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

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders

Drug Information available for: Nitroglycerin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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

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

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:

Buise MP, Ince C, Tilanus HW, Klein J, Gommers D, van Bommel J. The effect of nitroglycerin on microvascular perfusion and oxygenation during gastric tube reconstruction. Anesth Analg. 2005 Apr;100(4):1107-11.

Pierie JP, de Graaf PW, van Vroonhoven TJ, Obertop H. Healing of the cervical esophagogastrostomy. J Am Coll Surg. 1999 Apr;188(4):448-54. Review. No abstract available.

Jacobi CA, Zieren HU, Zieren J, Muller JM. Is tissue oxygen tension during esophagectomy a predictor of esophagogastric anastomotic healing? J Surg Res. 1998 Feb 1;74(2):161-4.

Siegemund M, van Bommel J, Ince C. Assessment of regional tissue oxygenation. Intensive Care Med. 1999 Oct;25(10):1044-60. Review. No abstract available.

Publications indexed to this study:

Buise M, van Bommel J, Jahn A, Tran K, Tilanus H, Gommers D. Intravenous nitroglycerin does not preserve gastric microcirculation during gastric tube reconstruction: a randomized controlled trial. Crit Care. 2006;10(5):R131.

Study ID Numbers:	MEC-2004-160
Study First Received:	June 7, 2006
Last Updated:	June 7, 2006
ClinicalTrials.gov Identifier:	NCT00335010
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

Study placed in the following topic categories:

Nitroglycerin
Digestive System Diseases
Digestive System Neoplasms
Esophageal disorder
Gastrointestinal Diseases

Head and Neck Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Esophageal Diseases
Esophageal neoplasm

Additional relevant MeSH terms:

Vasodilator Agents
Neoplasms
Neoplasms by Site

Therapeutic Uses
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009