Endomicroscopy for Assessment of Mucosal Healing

NCT01417715 | Completed DMC

• 1 other identifier: HN-0008
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn´s Disease; Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Histologic correlation

  up to three years

• Therapeutic effect

  up to three years

Study Arms (4)

Crohn´s disease - active

Patients with Crohn´s disease in the active phase.

Device: Endomicroscopy

Crohn´s disease - quiescent

Patients with Crohn´s disease in the quiescent phase.

Device: Endomicroscopy

Ulcerative colitis - active

Patients with ulcerative colitis in the active stage.

Device: Endomicroscopy

Ucerative colitis - quiescent

Patients with ulcerative colitis in the quiescent stage.

Device: Endomicroscopy

Interventions

Endomicroscopy DEVICE

Patients will undergo advanced endoscopic imaging using endomicroscopy. Findings will be compared to histopathological and clinical results.

Crohn´s disease - active; Crohn´s disease - quiescent; Ucerative colitis - quiescent; Ulcerative colitis - active

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

University of Erlangen-Nuremberg

Erlangen, 91054, Germany

Location

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2011
• First Posted: August 16, 2011
• Study Start: August 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: August 1, 2014
• Last Updated: December 14, 2020

Record last verified: 2020-12

Locations

DE (1)