Digital Holographic Microscopy: Evaluation of Histological Disease Activity in Patients With Ulcerative Colitis

NCT ID: NCT03464474

Last Updated: 2018-03-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2019-10-01

Brief Summary

Ulcerative colitis (UC) belongs to the group of inflammatory bowel disease (IBD) and is characterized by a chronic relapsing disease course. As uncontrolled intestinal inflammation can lead to severe disease complications, treatment of UC has evolved from sole treatment of symptoms up to histological remission which is marked by the absence of histological inflammation. To correctly assess and quantify the degree of histological inflammation in IBD patients remains difficult.

Digital holographic microscopy (DHM) is a new imaging technique belonging to quantitative phase contrast imaging. It is based on the detection of optical path-length delays in a stain-free manner, thereby providing a refractive index which directly correlates to tissue density.

This study aims to evaluate the role of DHM for quantifying the degree of histological inflammation in endoscopically acquired biopsies of UC patients in a prospective clinical trial. From 28 UC patients, the investigators will obtain endoscopically acquired colonic biopsies. The investigators will assess the degree of inflammation in these biopsies using DHM and in addition to this an experienced histopathologist will determine the degree of inflammation in these biopsies using a histological scoring system (Nancy-Score = goldstandard). Finally, the investigators will directly correlate the results from DHM analysis to the histological analysis using the Nancy-Score.

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Assessment of inflammation grade

Colonic biopsies will be acquired. Biopsies from all patients will be examined using digital holographic microscopy as well as performing a histopathological analysis using the Nancy-score (Goldstandard).

Group Type: EXPERIMENTAL

digital holographic microscopy

Intervention Type: DEVICE

Colonic biopsies from all patients will be assessed using digital holographic microscopy in comparison to the existing Goldstandard (histopathological analysis).

Interventions

digital holographic microscopy

Colonic biopsies from all patients will be assessed using digital holographic microscopy in comparison to the existing Goldstandard (histopathological analysis).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients with an indication for a colonoscopy

Exclusion Criteria

• Patients under 18 years, pregnancy
• Inability to have a patient education
• Bad conditions or other reasons prohibiting a colonoscopy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Muenster

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dominik Bettenworth, Professor, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Muenster

Locations

Unversity Clinic Muenster

Münster, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Dominik Bettenworth, Professor, MD

Role: CONTACT

dominik.bettenworth@ukmuenster.de

+492518357935

Arne Bokemeyer, MD

Role: CONTACT

arne.bokemeyer@ukmuenster.de

+492518357935

Facility Contacts

Dominik Bettenworth

Role: primary

Other Identifiers

2017-476-f-S

Identifier Type: -

Identifier Source: org_study_id