Endoscopy for Assessment of Mucosal Healing in IBD

University of Erlangen-Nürnberg Medical School

Status: Completed

Conditions: Crohn´s Disease; Ulcerative Colitis

Treatments: Device: High-definition white light endoscopy and i-Scan

Study type: Observational

Funder types: Other

Identifiers

NCT01417702

HN-0007

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. i-Scan use an endoscopic image from the video processor and reconstruct virtual images in real time, resulting in an improved contrast of the capillary patterns and enhancement of the mucosal surface (so called virtual chromoendoscopy).

The main objective of this study is to determine endoscopic features of mucosal healing in patients with IBD and to compare these features to clinical and histological data in order to establish a new endoscopic classification of mucosal healing and to evaluate mucosal healing as a parameter of remission and relapse.

Enrollment: 232 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)
• Proctocolectomy

Trial design

232 participants in 4 patient groups

Crohn´s disease - active

Description:

Patients in the active phase of the disease

Treatment:

Device: High-definition white light endoscopy and i-Scan

Crohn´s disease - quiescent

Description:

Patients in the quiescent phase of the disease

Treatment:

Device: High-definition white light endoscopy and i-Scan

Ulcerative colitis - active

Description:

Patients in the active phase of the disease

Treatment:

Device: High-definition white light endoscopy and i-Scan

Ucerative colitis - quiescent

Description:

Patients in the quiescent phase of the disease

Treatment:

Device: High-definition white light endoscopy and i-Scan