Endomicroscopy and Graft-versus-host Disease
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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 |
- 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.
- 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 |
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| 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 |
| 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 | |
| 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: | October 6, 2012 |
| 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 May 19, 2013