Endomicroscopy and Graft-versus-host Disease

NCT01583712 | Unknown

• 1 other identifier: EK 787/2010
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Haematopoietic Stem Cell Transplantation

Keywords

Confocal laser endomicroscopy; Small bowel imaging; Graft-versus-host disease; HSCT

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Sensitivity and Specificity of Endomicroscopy in enteral GvHD

  2 years

Study Arms (1)

Endomicroscopy

EXPERIMENTAL

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; Device: Confocal Laser Endomicroscope

Interventions

Confocal laser endomicroscopy PROCEDURE

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

Endomicroscopy

Confocal Laser Endomicroscope DEVICE

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

Endomicroscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[22\].

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, Austria

RECRUITING

Related Publications (26)

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  BACKGROUND

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MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Werner Dolak, MD

  Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterologie and Hepatologie

  PRINCIPAL INVESTIGATOR

• Andreas Puespoek, MD

  Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterology and Hepatology

  STUDY DIRECTOR

Central Study Contacts

Werner Dolak, MD

CONTACT

0043 1 40400 6589; werner.dolak@meduniwien.ac.at

Andreas Puespoek, MD

CONTACT

0043 1 40400 4739; andreas.puespoek@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicpal Investigator

Study Record Dates

• First Submitted: January 8, 2012
• First Posted: April 24, 2012
• Study Start: April 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: July 21, 2015

Record last verified: 2015-07

Locations

AU (1)