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

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.

Study Overview

• Status: Withdrawn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

• Study Type: Observational

Contacts and Locations

Study Locations

• Germany
  • Erlangen, Germany, 91054
    • University of Erlangen-Nuremberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with Crohn´s disease and ulcerative colitis. Only patients with mucosal healing are included.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Crohn's disease (CD); Patients with CD and mucosal healing on endoscopy.	Device: Endoscopy (EPK-i, Pentax, Tokyo, Japan); Patients will undergo white-light endoscopy. Any mucosal lesions will be recorded and findings will be compared to histopathological and clinical results.
Crohn's disease; Patients with CD and mucosal healing on endomicroscopy.	Device: Endomicroscopy (iCLE, Pentax, Tokyo, Japan); Patients will undergo endomicroscopy. Data will be recorded and findings will be compared to histopathological and clinical results.
Ulcerative colitis (UC); Patients with UC and mucosal healing on endoscopy.	Device: Endoscopy (EPK-i, Pentax, Tokyo, Japan); Patients will undergo white-light endoscopy. Any mucosal lesions will be recorded and findings will be compared to histopathological and clinical results.
Ulcerative colitis; Patients with UC and mucosal healing on endomicroscopy.	Device: Endomicroscopy (iCLE, Pentax, Tokyo, Japan); Patients will undergo endomicroscopy. Data will be recorded and findings will be compared to histopathological and clinical results.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mucosal healing	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.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histologic correlation	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.	3 years
Therapeutic effect	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.	3 years

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School
• Investigators: Principal Investigator: Markus F. Neurath, M.D., Ph.D., University of Erlangen-Nürnberg

Study record dates

Study Major Dates

• Study Start: April 1, 2012

Study Registration Dates

• First Submitted: January 23, 2012
• First Submitted That Met QC Criteria: January 29, 2012
• First Posted (Estimate): February 1, 2012

Study Record Updates

• Last Update Posted (Actual): December 14, 2020
• Last Update Submitted That Met QC Criteria: December 10, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Mucosal healing
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases
• Other Study ID Numbers: HN-0009