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Endomicroscopy and Graft-versus-host Disease

NCT01583712 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-07-21

No results posted yet for this study

Summary

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.

Conditions

  • Haematopoietic Stem Cell Transplantation

Interventions

PROCEDURE

Confocal laser endomicroscopy

Endomicroscopy of the upper gastrointestinal tract including endomicroscopic pictures taken every ten centimetres in the small bowel, gastric antrum, gastric corpus and esophagus.

DEVICE

Confocal Laser Endomicroscope

Pentax EC-3870 CIFK with the ISC-1000 confocal endomicroscopy processor - Pentax, Tokyo, Japan and Optiscan Pty Ltd, Notting Hill, Victoria, Australia

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • 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

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01583712 on ClinicalTrials.gov