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Endoscopy for Assessment of Mucosal Healing in IBD

This study is currently recruiting participants.
Verified January 2013 by University of Erlangen-Nürnberg Medical School
Sponsor:
Information provided by (Responsible Party):
Helmut Neumann, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT01417702
First received: August 10, 2011
Last updated: January 23, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Crohn´s Disease
Ulcerative Colitis
 Device: High-definition white light endoscopy and i-Scan

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Advanced Endoscopic Imaging Using HD+ Endoscopy and i-Scan for Assessment of Mucosal Healing in IBD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:
  • Mucosal healing [ Time Frame: up to three years ] [ Designated as safety issue: Yes ]
    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:
  • Histologic correlation [ Time Frame: up to three years ] [ Designated as safety issue: Yes ]
    Comparison of clinical and histopathological data with endoscopic findings to evaluate mucosal healing as a parameter of remission and relapse.

  • Therapeutic effect [ Time Frame: up to three years ] [ Designated as safety issue: Yes ]
    We will evaluate the effect of different therapeutic strategies (eg. anti-TNF treatment) on characteristics (e.g. erosions, ulcers, erythema) of mucosal healing.


Estimated Enrollment: 232
Study Start Date: August 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01417702

Contacts
Contact: Helmut Neumann, Professor helmut.neumann@uk-erlangen.de
Contact: Markus F. Neurath, Professor markus.neurath@uk-erlangen.de

Locations
Germany
University of Erlangen-Nuremberg Recruiting
Erlangen, Germany, 91054
Contact: Helmut Neumann, Professor     +4991318535000     helmut.neumann@uk-erlangen.de    
Principal Investigator: Helmut Neumann, Professor            
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Helmut Neumann, Professor, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT01417702     History of Changes
Other Study ID Numbers: HN-0007
Study First Received: August 10, 2011
Last Updated: January 23, 2013
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Crohn Disease
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013