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Early Detection of Mucosal Abnormalities in Graft-versus-host Disease

NCT02707354 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2019-08-29

No results posted yet for this study

Summary

Gastro-intestinal graft versus host disease (GVHD) is a major source of morbidity and mortality amongst allogenic hematopoietic stem cell transplantation (Allo-HSCT). The diagnosis is based on histological findings that involve colonic biopsies with a risk of bleeding, especially in case of thrombocytopenia. Moreover the diagnosis is frequently made at a clinical stage of the disease, after the appearance of gastro-intestinal symptoms. Endo-microscopy is a novel endoscopic technique that allow "optical biopsies" during a conventional endoscopy and has proved its efficiency in several indications. In a pilot study the investigators showed that it had good sensibility and sensitivity compared to histology as gold standard. Therefore this study aim to identify endo-microscopic criteria allowing the early diagnosis of GHVD before its clinical manifestations.

Conditions

Interventions

DEVICE

Probe based confocal laser endomicroscopy (Cellvizio)

The probe is a miniaturized microscope in the form of a fiber which is inserted through the endoscope and brought into contact with the mucosa. It thus allows for a "live virtual biopsy", that is to say, obtaining real-time microscopic virtual image of the mucosa. It requires an intra-veinous injection of 5 mL of 10% fluorescein diluted in 50 cc of saline serum. The images obtained during the examination will be recorded via the endomicroscopy console so that two endoscopists blinded from the macroscopic and histological findings can review the data.

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Emmanuel Coron, MD-PHD · Nantes University Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-03
Primary Completion
2018-08-20
Completion
2018-08-20

Countries

  • France

Study Locations

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Entities

Diseases

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 NCT02707354 on ClinicalTrials.gov