Intravenous NTG to Preserve Gastric Microcirculation During Gastric Tube Reconstruction

Esophageal Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00335010
• Other study ID #: MEC-2004-160
• Status: Completed
• Phase: N/A
• First received: June 7, 2006
• Last updated: June 7, 2006
• Start date: May 2005
• Est. completion date: December 2005

Study information

• Verified date: June 2006
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Planned esophagectomy with gastric tube reconstruction

• written informed consent

• ASA I and II

Exclusion Criteria:

• younger than 18

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Microcirculation

Intervention

Drug:
• Nitroglycerin

Locations

Country	Name	City	State
Netherlands	Erasmus MC	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (4)

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. — View Citation

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

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. — View Citation

Siegemund M, van Bommel J, Ince C. Assessment of regional tissue oxygenation. Intensive Care Med. 1999 Oct;25(10):1044-60. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	differences in Microvascular bloodflow
Primary	differences in microvascular hemoglobinsaturation
Secondary	differences in anastomotic leakage
Secondary	differences in anastomotic stenosis