Endoscopy for Assessment of Mucosal Healing in IBD

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01417702
• Other study ID #: HN-0007
• Status: Completed
• Start date: August 2011
• Est. completion date: November 2014

Study information

• Verified date: December 2020
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: November 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Crohn Disease
• Crohn´s Disease
• Ulcerative Colitis

Intervention

Device:
• High-definition white light endoscopy and i-Scan
Patients will undergo advanced endoscopic imaging. Findings will be compared to histopathological and clinical results.

Locations

Country	Name	City	State
Germany	University of Erlangen-Nuremberg	Erlangen

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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