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Intravenous NTG to Preserve Gastric Microcirculation During Gastric Tube Reconstruction

Not Applicable
Completed
Conditions
Esophageal Neoplasms
Microcirculation
Registration Number
NCT00335010
Lead Sponsor
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
32
Inclusion Criteria
  • Planned esophagectomy with gastric tube reconstruction
  • written informed consent
  • ASA I and II
Exclusion Criteria
  • younger than 18

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
differences in Microvascular bloodflow
differences in microvascular hemoglobinsaturation
Secondary Outcome Measures
NameTimeMethod
differences in anastomotic leakage
differences in anastomotic stenosis

Trial Locations

Locations (1)

Erasmus MC

🇳🇱

Rotterdam, Netherlands

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