Endoscopy and Endomicroscopy for Assessment of Mucosal Healing in Inflammatory Bowel Disease (IBD)

Withdrawn

• Conditions: Crohn's Disease; Ulcerative Colitis; Inflammatory Bowel Disease
• Interventions: Device: Endomicroscopy (iCLE, Pentax, Tokyo, Japan); Device: Endoscopy (EPK-i, Pentax, Tokyo, Japan)

• Registration Number: NCT01524120
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

Brief Summary

Inflammatory bowel disease (IBD) encompasses two major forms of chronic intestinal disorders, Crohn's disease and ulcerative colitis (UC). Diagnosis is based on several macroscopic and histologic features including patterns of inflammation, crypt abscesses and granulomas. Confocal laser endomicroscopy (CLE) is rapidly emerging as a valuable tool for gastrointestinal endoscopic imaging, enabling the endoscopist to obtain an "optical biopsy" of the gastrointestinal mucosa during the endoscopic procedure.

The main objective of this study is to determine endoscopic and endomicroscopic features of mucosal healing in patients with IBD.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-23
• Study First Submitted QC: 2012-01-29
• Study First Posted: 2012-02-01
• Study Start: 2012-04
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-10
• Last Update Posted: 2020-12-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Written informed consent
• Age 18-85 years
• Ability of subjects to understand character and individual consequences of clinical trial
• Subjects undergoing colonoscopy

Exclusion Criteria

• Inability to provide written informed consent
• Severe Coagulopathy (Prothrombin time < 50% of control, Partial thromboplastin time > 50 s)
• Pregnancy or breast feeding
• Active gastrointestinal bleeding
• Residing in institutions (e.g. prison)
• Known allergy against fluorescein

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ulcerative colitis	Endomicroscopy (iCLE, Pentax, Tokyo, Japan)	Patients with UC and mucosal healing on endomicroscopy.
Ulcerative colitis (UC)	Endoscopy (EPK-i, Pentax, Tokyo, Japan)	Patients with UC and mucosal healing on endoscopy.
Crohn's disease (CD)	Endoscopy (EPK-i, Pentax, Tokyo, Japan)	Patients with CD and mucosal healing on endoscopy.
Crohn's disease	Endomicroscopy (iCLE, Pentax, Tokyo, Japan)	Patients with CD and mucosal healing on endomicroscopy.

Primary Outcome Measures

Name	Time	Method
Mucosal healing	3 years	We will determine endoscopic (e.g. ulcera, erythema) and endomicroscopic features of mucosal inflammation (e.g. goblet cell depletion, leackage, microvessel density) in IBD in order to define new criteria of mucosal healing and to define factors of disease remission and relapse.

Secondary Outcome Measures

Name	Time	Method
Histologic correlation	3 years	Comparison of clinical and histopathological data with endoscopic and endomicroscopic findings to evaluate mucosal healing as a parameter of remission and relapse in patients with IBD.
Therapeutic effect	3 years	We will evaluate the effect of different therapeutic strategies (eg. anti-TNF treatment, corticosteroids) on characteristics of mucosal healing (e.g. goblet cell depletion, microvessels, leakage) and remission and relapse rate.

Trial Locations

Locations (1)

University of Erlangen-Nuremberg; 🇩🇪 Erlangen, Germany