Endoscopy for Assessment of Mucosal Healing in IBD

This study is currently recruiting participants. (see Contacts and Locations)
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

August 10, 2011
January 23, 2013
August 2011
May 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01417702 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Crohn´s Disease
  • Ulcerative Colitis
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 - active
    Patients in the active phase of the disease
    Intervention: Device: High-definition white light endoscopy and i-Scan
  • Crohn´s disease - quiescent
    Patients in the quiescent phase of the disease
    Intervention: Device: High-definition white light endoscopy and i-Scan
  • Ulcerative colitis - active
    Patients in the active phase of the disease
    Intervention: Device: High-definition white light endoscopy and i-Scan
  • Ucerative colitis - quiescent
    Patients in the quiescent phase of the disease
    Intervention: Device: High-definition white light endoscopy and i-Scan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
232
November 2014
May 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact: Helmut Neumann, Professor helmut.neumann@uk-erlangen.de
Contact: Markus F. Neurath, Professor markus.neurath@uk-erlangen.de
Germany
 
NCT01417702
HN-0007
Yes
Helmut Neumann, University of Erlangen-Nürnberg Medical School
University of Erlangen-Nürnberg Medical School
Not Provided
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
University of Erlangen-Nürnberg Medical School
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP