Endoscopy for Assessment of Mucosal Healing in IBD

Completed

• Conditions: Crohn´s Disease; Ulcerative Colitis
• Interventions: Device: High-definition white light endoscopy and i-Scan

• Registration Number: NCT01417702
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-10
• Study First Submitted QC: 2011-08-15
• Study First Posted: 2011-08-16
• Primary Completion: 2014-05
• Study Completion: 2014-11
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-10
• Last Update Posted: 2020-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 232

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Crohn´s disease - active	High-definition white light endoscopy and i-Scan	Patients in the active phase of the disease
Crohn´s disease - quiescent	High-definition white light endoscopy and i-Scan	Patients in the quiescent phase of the disease
Ulcerative colitis - active	High-definition white light endoscopy and i-Scan	Patients in the active phase of the disease
Ucerative colitis - quiescent	High-definition white light endoscopy and i-Scan	Patients in the quiescent phase of the disease

Primary Outcome Measures

Name	Time	Method
Mucosal healing	up to three years	We will determine high-definition white light endoscopic and i-Scan features of mucosal inflammation (e.g. erosions, erythema, ulcerous lesions) in IBD in order to establish a new endoscopic classification of mucosal healing.

Secondary Outcome Measures

Name	Time	Method
Therapeutic effect	up to three years	We will evaluate the effect of different therapeutic strategies (eg. anti-TNF treatment) on characteristics (e.g. erosions, ulcers, erythema) of mucosal healing.
Histologic correlation	up to three years	Comparison of clinical and histopathological data with endoscopic findings to evaluate mucosal healing as a parameter of remission and relapse.

Trial Locations

Locations (1)

University of Erlangen-Nuremberg; 🇩🇪 Erlangen, Germany