Intravenous NTG to Preserve Gastric Microcirculation During Gastric Tube Reconstruction

Condition(s) targeted: Esophageal Neoplasms; Microcirculation

Intervention: Nitroglycerin (Drug)

Phase: N/A

Status: Completed

Sponsored by: Erasmus Medical Center

Official(s) and/or principal investigator(s):
Diederik Gommers, MD, PhD, Study Chair, Affiliation: Erasmus MC
Marc Buise, MD, Principal Investigator, Affiliation: Erasmus MC
Jasper van Bommel, MD, PhD, Study Director, Affiliation: Erasmus MC
Huug Tilanus, MD, PhD, Principal Investigator, Affiliation: Erasmus MC
Khe Tran, MD, Principal Investigator, Affiliation: Erasmus MC

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.

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

Primary outcome:

differences in Microvascular bloodflow

differences in microvascular hemoglobinsaturation

Secondary outcome:

differences in anastomotic leakage

differences in anastomotic stenosis

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Planned esophagectomy with gastric tube reconstruction

- written informed consent

- ASA I and II

Exclusion Criteria:

- younger than 18

Erasmus MC, Rotterdam 3000ZA, Netherlands

Related 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.

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.

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

Starting date: May 2005
Last updated: June 7, 2006