Endomicroscopy for Assessment of Mucosal Healing

Advanced Endoscopic Imaging Using Endomicroscopy for Assessment of Mucosal Healing in 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 endomicroscopic features of mucosal healing in patients with IBD.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis; Crohn´s Disease
• Intervention / Treatment: Device: Endomicroscopy

• Study Type: Observational
• Enrollment (Actual): 84

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: Non-Probability Sample

Study Population

Patients with Crohn´s disease and ulcerative colitis in the active and quiescent phase of the disease.

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
• Proctocolectomy

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Crohn´s disease - active; Patients with Crohn´s disease in the active phase.	Device: Endomicroscopy; Patients will undergo advanced endoscopic imaging using endomicroscopy. Findings will be compared to histopathological and clinical results.
Crohn´s disease - quiescent; Patients with Crohn´s disease in the quiescent phase.	Device: Endomicroscopy; Patients will undergo advanced endoscopic imaging using endomicroscopy. Findings will be compared to histopathological and clinical results.
Ulcerative colitis - active; Patients with ulcerative colitis in the active stage.	Device: Endomicroscopy; Patients will undergo advanced endoscopic imaging using endomicroscopy. Findings will be compared to histopathological and clinical results.
Ucerative colitis - quiescent; Patients with ulcerative colitis in the quiescent stage.	Device: Endomicroscopy; Patients will undergo advanced endoscopic imaging using endomicroscopy. 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 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.	up to three years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histologic correlation	Comparison of clinical and histopathological data with endoscopic findings to evaluate mucosal healing as a parameter of remission and relapse in patients with IBD.	up to three years
Therapeutic effect	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).	up to three years

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School
• Investigators: Principal Investigator: Helmut Neumann, Professor, Department of Medicine I, University of Erlangen-Nuremberg, Germany; Principal Investigator: Markus F. Neurath, Professor, Department of Medicine I, University of Erlangen-Nuremberg, Germany

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2011
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: August 10, 2011
• First Submitted That Met QC Criteria: August 15, 2011
• First Posted (Estimate): August 16, 2011

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

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: HN-0008