Intravenous NTG to Preserve Gastric Microcirculation During Gastric Tube Reconstruction
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Esophageal Neoplasms Microcirculation |
Drug: Nitroglycerin |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| 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 |
- differences in Microvascular bloodflow
- differences in microvascular hemoglobinsaturation
- differences in anastomotic leakage
- differences in anastomotic stenosis
| Estimated Enrollment: | 32 |
| Study Start Date: | May 2005 |
| Estimated Study Completion Date: | December 2005 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Planned esophagectomy with gastric tube reconstruction
- written informed consent
- ASA I and II
Exclusion Criteria:
- younger than 18
Contacts and Locations| Netherlands | |
| Erasmus MC | |
| Rotterdam, Netherlands, 3000ZA | |
| Study Chair: | Diederik Gommers, MD, PhD | Erasmus MC |
| Principal Investigator: | Marc Buise, MD | Erasmus MC |
| Study Director: | Jasper van Bommel, MD, PhD | Erasmus MC |
| Principal Investigator: | Huug Tilanus, MD, PhD | Erasmus MC |
| Principal Investigator: | Khe Tran, MD | Erasmus MC |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00335010 History of Changes |
| Other Study ID Numbers: | MEC-2004-160 |
| Study First Received: | June 7, 2006 |
| Last Updated: | June 7, 2006 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Erasmus Medical Center:
|
Nitroglycerine gastroesophageal anastomosis microvascular bloodflow microvascular hemoglobinsaturation |
Additional relevant MeSH terms:
|
Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms |
Neoplasms by Site Head and Neck Neoplasms Nitroglycerin Vasodilator Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on October 16, 2012
