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Intravenous NTG to Preserve Gastric Microcirculation During Gastric Tube Reconstruction

Primary Purpose

Esophageal Neoplasms, Microcirculation

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Nitroglycerin

About this trial

This is an interventional prevention trial for Esophageal Neoplasms focused on measuring Nitroglycerine, gastroesophageal anastomosis, microvascular bloodflow, microvascular hemoglobinsaturation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Planned esophagectomy with gastric tube reconstruction written informed consent ASA I and II Exclusion Criteria: younger than 18

Sites / Locations

Erasmus MC

Outcomes

Primary Outcome Measures

differences in Microvascular bloodflow

differences in microvascular hemoglobinsaturation

Secondary Outcome Measures

differences in anastomotic leakage

differences in anastomotic stenosis

Full Information

NCT ID

NCT00335010

First Posted

June 7, 2006

Last Updated

June 7, 2006

Sponsor

Erasmus Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00335010

Brief Title

Intravenous NTG to Preserve Gastric Microcirculation During Gastric Tube Reconstruction

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 Type

Interventional

2. Study Status

Record Verification Date

June 2006

Overall Recruitment Status

Completed

Study Start Date

May 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Erasmus Medical Center

4. Oversight

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Neoplasms, Microcirculation

Keywords

Nitroglycerine, gastroesophageal anastomosis, microvascular bloodflow, microvascular hemoglobinsaturation

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

32 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Nitroglycerin

Primary Outcome Measure Information:

Title

differences in Microvascular bloodflow

Title

differences in microvascular hemoglobinsaturation

Secondary Outcome Measure Information:

Title

differences in anastomotic leakage

Title

differences in anastomotic stenosis

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Planned esophagectomy with gastric tube reconstruction written informed consent ASA I and II Exclusion Criteria: younger than 18

Overall Study Officials: