Endomicroscopy and Graft-versus-host Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Werner Dolak, MD, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01583712
First received: January 8, 2012
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Haematopoietic Stem Cell Transplantation
Procedure: Confocal laser endomicroscopy
Device: Confocal Laser Endomicroscope

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Diagnosis of Acute Gastrointestinal Graft-versus-Host Disease by Early Endomicroscopic Features of the Small Intestine

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • GvHD-markers on endomicroscopy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Establishing endomicroscopic markers of acute graft-versus-host disease in the small bowel. This outcome is a qualitative endpoint. It will be assessed descriptively.


Secondary Outcome Measures:
  • Sensitivity and Specificity of Endomicroscopy in enteral GvHD [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    At the end of the study all study derived endomicroscopic pictures will be judged by two board certified pathologists regarding presence or absence of GvHD. In comparison to the corresponding histological sections sensitivity and specificity of the technique will be calculated


Estimated Enrollment: 40
Study Start Date: April 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endomicroscopy
All patients included in the study will undergo endomicroscopy of the upper GI-tract including the reachable parts of the small bowel.
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients after haematopoietic stem cell transplantation (HSCT) who are referred to our department for clarification of one of the following symptoms:

  • anorexia
  • nausea
  • vomiting
  • abdominal pain
  • diarrhoea
  • intestinal bleeding

To exclude possible side effects of the conditioning therapy, GI symptoms must have occurred or persisted 20 days after the respective transplantation date [22].

Exclusion criteria:

  • infection with CMV or HSV
  • bacterial infection of the GI tract
  • medication related symptoms
  • patients allergic to one of the drug components (including drugs used for conscious sedation like propofol or midazolam as well as fluorescein, the fluorescent dye used for CLE )
  • refusal to participate in the study
  • patient's age below 18 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01583712

Contacts
Contact: Werner Dolak, MD 0043 1 40400 6589 werner.dolak@meduniwien.ac.at
Contact: Andreas Puespoek, MD 0043 1 40400 4739 andreas.puespoek@meduniwien.ac.at

Locations
Austria
Medical University of Vienna Recruiting
Vienna, Austria
Contact: Werner Dolak, MD    0043 1 40400 6589    werner.dolak@meduniwien.ac.at   
Contact: Andreas Puespoek, MD    0043 1 40400 4739    andreas.puespoek@meduniwien.ac.at   
Principal Investigator: Werner Dolak, MD         
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Werner Dolak, MD Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterologie and Hepatologie
Study Director: Andreas Puespoek, MD Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterology and Hepatology
  More Information

Publications:

Responsible Party: Werner Dolak, MD, Prinicpal Investigator, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01583712     History of Changes
Other Study ID Numbers: EK 787/2010
Study First Received: January 8, 2012
Last Updated: January 22, 2014
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
Confocal laser endomicroscopy
Small bowel imaging
Graft-versus-host disease
HSCT

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases

ClinicalTrials.gov processed this record on September 30, 2014