Endoscopy for Assessment of Mucosal Healing in IBD

Advanced Endoscopic Imaging Using HD+ Endoscopy and i-Scan for Assessment of Mucosal Healing in IBD

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.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis; Crohn´s Disease
• Intervention / Treatment: Device: High-definition white light endoscopy and i-Scan

• Study Type: Observational
• Enrollment (Actual): 232

Contacts and Locations

Study Locations

• Germany
  • Erlangen, Germany, 91054
    • University of Erlangen-Nuremberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Crohn´s disease and ulcerative colitis were prospectively included.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Crohn´s disease - active; Patients in the active phase of the disease	Device: High-definition white light endoscopy and i-Scan; Patients will undergo advanced endoscopic imaging. Findings will be compared to histopathological and clinical results.
Crohn´s disease - quiescent; Patients in the quiescent phase of the disease	Device: High-definition white light endoscopy and i-Scan; Patients will undergo advanced endoscopic imaging. Findings will be compared to histopathological and clinical results.
Ulcerative colitis - active; Patients in the active phase of the disease	Device: High-definition white light endoscopy and i-Scan; Patients will undergo advanced endoscopic imaging. Findings will be compared to histopathological and clinical results.
Ucerative colitis - quiescent; Patients in the quiescent phase of the disease	Device: High-definition white light endoscopy and i-Scan; Patients will undergo advanced endoscopic imaging. Findings will be compared to histopathological and clinical results.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mucosal healing	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.	up to three years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2011
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: August 10, 2011
• First Submitted That Met QC Criteria: August 15, 2011
• First Posted (Estimate): August 16, 2011

Study Record Updates

• Last Update Posted (Actual): December 14, 2020
• Last Update Submitted That Met QC Criteria: December 10, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: HN-0007