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

University of Erlangen-Nürnberg Medical School

Status: Withdrawn

Conditions: Inflammatory Bowel Disease; Ulcerative Colitis; Crohn's Disease

Treatments: Device: Endoscopy (EPK-i, Pentax, Tokyo, Japan); Device: Endomicroscopy (iCLE, Pentax, Tokyo, Japan)

Study type: Observational

Funder types: Other

Identifiers

NCT01524120

HN-0009

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 4 patient groups

Crohn's disease (CD)

Description:

Patients with CD and mucosal healing on endoscopy.

Treatment:

Device: Endoscopy (EPK-i, Pentax, Tokyo, Japan)

Device: Endoscopy (EPK-i, Pentax, Tokyo, Japan)

Crohn's disease

Description:

Patients with CD and mucosal healing on endomicroscopy.

Treatment:

Device: Endomicroscopy (iCLE, Pentax, Tokyo, Japan)

Device: Endomicroscopy (iCLE, Pentax, Tokyo, Japan)

Ulcerative colitis (UC)

Description:

Patients with UC and mucosal healing on endoscopy.

Treatment:

Device: Endoscopy (EPK-i, Pentax, Tokyo, Japan)

Device: Endoscopy (EPK-i, Pentax, Tokyo, Japan)

Ulcerative colitis

Description:

Patients with UC and mucosal healing on endomicroscopy.

Treatment:

Device: Endomicroscopy (iCLE, Pentax, Tokyo, Japan)

Device: Endomicroscopy (iCLE, Pentax, Tokyo, Japan)