Endoscopy for Assessment of Mucosal Healing in IBD

NCT01417702 | Completed DMC

• 1 other identifier: HN-0007
• Study Type: observational
• Target: 232
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn´s Disease; Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Histologic correlation

  up to three years

• Therapeutic effect

  up to three years

Study Arms (4)

Crohn´s disease - active

Patients in the active phase of the disease

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

Crohn´s disease - quiescent

Patients in the quiescent phase of the disease

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

Ulcerative colitis - active

Patients in the active phase of the disease

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

Ucerative colitis - quiescent

Patients in the quiescent phase of the disease

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

Interventions

High-definition white light endoscopy and i-Scan DEVICE

Patients will undergo advanced endoscopic imaging. Findings will be compared to histopathological and clinical results.

Crohn´s disease - active; Crohn´s disease - quiescent; Ucerative colitis - quiescent; Ulcerative colitis - active

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Written informed consent
• Age 18-85 years
• Ability of subjects to understand character and individual consequences of clinical trial
• Subjects undergoing colonoscopy

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

University of Erlangen-Nuremberg

Erlangen, 91054, Germany

Location

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2011
• First Posted: August 16, 2011
• Study Start: August 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 14, 2020

Record last verified: 2020-12

Locations

DE (1)