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Intravenous NTG to Preserve Gastric Microcirculation During Gastric Tube Reconstruction

NCT ID: NCT00335010

Last Updated: 2006-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2005-12-31

Brief Summary

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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

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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.

Conditions

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Esophageal Neoplasms Microcirculation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Nitroglycerin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Planned esophagectomy with gastric tube reconstruction
* written informed consent
* ASA I and II

Exclusion Criteria

* younger than 18
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erasmus Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Diederik Gommers, MD, PhD

Role: STUDY_CHAIR

Erasmus Medical Center

Marc Buise, MD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Jasper van Bommel, MD, PhD

Role: STUDY_DIRECTOR

Erasmus Medical Center

Huug Tilanus, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Khe Tran, MD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

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Erasmus MC

Rotterdam, , Netherlands

Site Status

Countries

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Netherlands

References

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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):1107-1111. doi: 10.1213/01.ANE.0000147665.60613.CA.

Reference Type BACKGROUND
PMID: 15781529 (View on PubMed)

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. doi: 10.1016/s1072-7515(99)00003-4. No abstract available.

Reference Type BACKGROUND
PMID: 10195730 (View on PubMed)

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. doi: 10.1006/jsre.1997.5239.

Reference Type BACKGROUND
PMID: 9587355 (View on PubMed)

Siegemund M, van Bommel J, Ince C. Assessment of regional tissue oxygenation. Intensive Care Med. 1999 Oct;25(10):1044-60. doi: 10.1007/s001340051011. No abstract available.

Reference Type BACKGROUND
PMID: 10551958 (View on PubMed)

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. doi: 10.1186/cc5043.

Reference Type DERIVED
PMID: 16970804 (View on PubMed)

Other Identifiers

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MEC-2004-160

Identifier Type: -

Identifier Source: org_study_id