Endomicroscopy for Assessment of Mucosal Healing

Completed

• Conditions: Crohn´s Disease; Ulcerative Colitis
• Interventions: Device: Endomicroscopy

• Registration Number: NCT01417715
• 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 endomicroscopic features of mucosal healing in patients with IBD.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-10
• Study First Submitted QC: 2011-08-15
• Study First Posted: 2011-08-16
• Primary Completion: 2014-05
• Study Completion: 2014-08
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-10
• Last Update Posted: 2020-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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
• Proctocolectomy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Crohn´s disease - active	Endomicroscopy	Patients with Crohn´s disease in the active phase.
Crohn´s disease - quiescent	Endomicroscopy	Patients with Crohn´s disease in the quiescent phase.
Ucerative colitis - quiescent	Endomicroscopy	Patients with ulcerative colitis in the quiescent stage.
Ulcerative colitis - active	Endomicroscopy	Patients with ulcerative colitis in the active stage.

Primary Outcome Measures

Name	Time	Method
Mucosal healing	up to three years	We will determine endomicroscopic features of mucosal inflammation (e.g. goblet cell depletion, leackage, microvessel density) in IBD in order to establish a new endoscopic classification of mucosal healing.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Erlangen-Nuremberg; 🇩🇪 Erlangen, Germany