NCT01583712|Unknown
Endomicroscopy and Graft-versus-host Disease
Diagnosis of Acute Gastrointestinal Graft-versus-Host Disease by Early Endomicroscopic Features of the Small Intestine
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Diagnosis of Acute Gastrointestinal Graft-versus-Host Disease by Early Endomicroscopic Features of the Small Intestine
Sponsor study identifier
interventional
40
1 country
1
Study Start
April 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Early diagnosis of acute Gastrointestinal Graft-versus-Host disease (aGI-GvHD) has a strong impact on morbidity and mortality of patients who underwent haematopoietic stem cell transplantation (HSCT). Recent results at the investigators department showed that mucosal biopsies from the small intestine have a high diagnostic yield for aGI-GvHD specific changes. By performing an enteroscopic examination, aGI-GvHD suspected patients can be prevented from colonoscopy and prior bowel preparation which is clinically important, considering the rather bad general condition of this patient group. To further reduce invasive procedures the investigators want to evaluate the in vivo histological features of aGI-GvHD in the small bowel. Therefore aGI-GvHD suspected patients will undergo confocal laser endomicroscopy of the upper GI-tract, including duodenum and jejunum, in the context of a prospective clinical pilot trial. The histological evaluation of biopsy samples taken from these sites will be used as comparable gold standard. Endomicroscopic aspects of patients with celiac disease, infectious enteritis, inflammatory bowel disease and healthy subjects should serve as controls. If it is possible to diagnose aGI-GvHD from endomicroscopic features of the small bowel alone, this could be another important step to improve the diagnostic management of post HSCT patients, especially when taking of biopsy samples is difficult because of a bad coagulation status. Additionally, an accurate diagnosis in vivo could lead to immediate treatment to prevent progression and site spreading of the disease.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 8, 2012
Actual (reported)April 2012
Date type not reportedThis date has not been verified as actual or estimated.
April 24, 2012
Actual (reported)March 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
GvHD-markers on endomicroscopy
Establishing endomicroscopic markers of acute graft-versus-host disease in the small bowel. This outcome is a qualitative endpoint. It will be assessed descriptively.
2 years
Sensitivity and Specificity of Endomicroscopy in enteral GvHD
2 years
All patients included in the study will undergo endomicroscopy of the upper GI-tract including the reachable parts of the small bowel.
Endomicroscopy of the upper gastrointestinal tract including endomicroscopic pictures taken every ten centimetres in the small bowel, gastric antrum, gastric corpus and esophagus.
Pentax EC-3870 CIFK with the ISC-1000 confocal endomicroscopy processor - Pentax, Tokyo, Japan and Optiscan Pty Ltd, Notting Hill, Victoria, Australia
Medical University of Vienna
Vienna, Austria
Ferrara JL, Levine JE, Reddy P, Holler E. Graft-versus-host disease. Lancet. 2009 May 2;373(9674):1550-61. doi: 10.1016/S0140-6736(09)60237-3. Epub 2009 Mar 11.
Schulenburg A, Turetschek K, Wrba F, Vogelsang H, Greinix HT, Keil F, Mitterbauer M, Kalhs P. Early and late gastrointestinal complications after myeloablative and nonmyeloablative allogeneic stem cell transplantation. Ann Hematol. 2004 Feb;83(2):101-6. doi: 10.1007/s00277-003-0756-4. Epub 2003 Nov 13.
Werner Dolak, MD
Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterologie and Hepatologie
Andreas Puespoek, MD
Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterology and Hepatology
First Submitted
January 8, 2012
First Posted
April 24, 2012
Study Start
April 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2016
Estimated (date passed)Endomicroscopic Evaluation of Food-induced Gastrointestinal Mucosal Alteration
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 21, 2015
Record last verified: 2015-07
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