Clinical trial NCT00335010: Intravenous NTG to Preserve Gastric Microcirculation During Gastric Tube Reconstruction
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Neoplasms
Microcirculation
Keywords: Nitroglycerine
gastroesophageal anastomosis
microvascular bloodflow
microvascular hemoglobinsaturation
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2006-06-08
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* younger than 18

Primary outcomes:
measure: differences in Microvascular bloodflow
measure: differences in microvascular hemoglobinsaturation
Secondary outcomes:
measure: differences in anastomotic leakage
measure: differences in anastomotic stenosis
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
Study officials:
affiliation: Erasmus Medical Center
name: Diederik Gommers, MD, PhD
role: STUDY_CHAIR
affiliation: Erasmus Medical Center
name: Marc Buise, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medical Center
name: Jasper van Bommel, MD, PhD
role: STUDY_DIRECTOR
affiliation: Erasmus Medical Center
name: Huug Tilanus, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medical Center
name: Khe Tran, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1016/s1072-7515(99)00003-4. No abstract available.
citation: 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.
citation: 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.
citation: 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.