Endomicroscopy for Assessment of Mucosal Healing

University of Erlangen-Nürnberg Medical School

Status: Completed

Conditions: Crohn´s Disease; Ulcerative Colitis

Treatments: Device: Endomicroscopy

Study type: Observational

Funder types: Other

Identifiers

NCT01417715

HN-0008

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 endomicroscopic features of mucosal healing in patients with IBD.

Enrollment: 84 patients

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
• Proctocolectomy

Trial design

84 participants in 4 patient groups

Crohn´s disease - active

Description:

Patients with Crohn´s disease in the active phase.

Treatment:

Device: Endomicroscopy

Crohn´s disease - quiescent

Description:

Patients with Crohn´s disease in the quiescent phase.

Treatment:

Device: Endomicroscopy

Ulcerative colitis - active

Description:

Patients with ulcerative colitis in the active stage.

Treatment:

Device: Endomicroscopy

Ucerative colitis - quiescent

Description:

Patients with ulcerative colitis in the quiescent stage.

Treatment:

Device: Endomicroscopy