Endomicroscopy and Graft-versus-host Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01583712
Recruitment Status : Unknown
Verified July 2015 by Werner Dolak, MD, Medical University of Vienna.
Recruitment status was:  Recruiting
First Posted : April 24, 2012
Last Update Posted : July 21, 2015
Information provided by (Responsible Party):
Werner Dolak, MD, Medical University of Vienna

Brief 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.

Condition or disease Intervention/treatment
Haematopoietic Stem Cell Transplantation Procedure: Confocal laser endomicroscopy Device: Confocal Laser Endomicroscope

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnosis of Acute Gastrointestinal Graft-versus-Host Disease by Early Endomicroscopic Features of the Small Intestine
Study Start Date : April 2012
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. GvHD-markers on endomicroscopy [ Time Frame: 2 years ]
    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 :
  1. Sensitivity and Specificity of Endomicroscopy in enteral GvHD [ Time Frame: 2 years ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01583712

Contact: Werner Dolak, MD 0043 1 40400 6589
Contact: Andreas Puespoek, MD 0043 1 40400 4739

Medical University of Vienna Recruiting
Vienna, Austria
Contact: Werner Dolak, MD    0043 1 40400 6589   
Contact: Andreas Puespoek, MD    0043 1 40400 4739   
Principal Investigator: Werner Dolak, MD         
Sponsors and Collaborators
Medical University of Vienna
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

Dolak W, Rabitsch W, Kalhs P, Wrba F, Gangl A, Haefner M. The Role of Enteroscopy in the Diagnostic Management of Acute Gastrointestinal Graft-Versus-Host Disease: A Single Centre Experience. Gastrointest Endosc 2009 Apr;69(5):AB195-6.
Kiesslich R, Galle P, Neurath M. Atlas of endomicroscopy. Springer Medical Publishing. 2008

Responsible Party: Werner Dolak, MD, Prinicpal Investigator, Medical University of Vienna Identifier: NCT01583712     History of Changes
Other Study ID Numbers: EK 787/2010
First Posted: April 24, 2012    Key Record Dates
Last Update Posted: July 21, 2015
Last Verified: July 2015

Keywords provided by Werner Dolak, MD, Medical University of Vienna:
Confocal laser endomicroscopy
Small bowel imaging
Graft-versus-host disease

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