Intravenous NTG to Preserve Gastric Microcirculation During Gastric Tube Reconstruction

Tracking Information
First Submitted Date ICMJE	June 7, 2006
First Posted Date ICMJE	June 8, 2006
Last Update Posted Date	June 8, 2006
Study Start Date ICMJE	May 2005
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: June 7, 2006)	differences in Microvascular bloodflow; differences in microvascular hemoglobinsaturation
Original Primary Outcome Measures ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ICMJE; (submitted: June 7, 2006)	differences in anastomotic leakage; differences in anastomotic stenosis
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Intravenous NTG to Preserve Gastric Microcirculation During Gastric Tube Reconstruction
Official Title ICMJE	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
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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Prevention
Condition ICMJE	Esophageal Neoplasms; Microcirculation
Intervention ICMJE	Drug: Nitroglycerin
Study Arms	Not Provided
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.; 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Enrollment ICMJE; (submitted: June 7, 2006)	32
Original Enrollment ICMJE	Same as current
Study Completion Date	December 2005
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	Inclusion Criteria: Planned esophagectomy with gastric tube reconstruction; written informed consent; ASA I and II Exclusion Criteria: younger than 18
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Netherlands
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00335010
Other Study ID Numbers ICMJE	MEC-2004-160
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	Erasmus Medical Center
Collaborators ICMJE	Not Provided
Investigators ICMJE	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
PRS Account	Erasmus Medical Center
Verification Date	June 2006
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP