Clinical trial NCT03464474: Digital Holographic Microscopy: Evaluation of Histological Disease Activity in Patients With Ulcerative Colitis
Official title: Evaluation of Digital Holographic Microscopy for Quantification and Characterization of the Histological Disease Activity in Patients With Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colitis, Ulcerative
Inflammatory Bowel Diseases
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2018-03-14
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Colonic biopsies from 28 patients with ulcerative colitis will be endoscopically acquired. These biopsies will be examined by digital holographic microscopic and by analysis due to an experienced histopathologists using an established scoring system (Goldstandard).
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Analysis of the inflammation grade of mucosal biopsies of ulcerative colitis patients
timeFrame: Endoscopically acquired biopsies will immediately be transported to the laboratory. After processing, biopsies can be used for histological assessment and for digital holographic microscopy; biopsies will be assessed within a time period up to 56 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Münster
country: Germany
facility: Unversity Clinic Muenster
Study officials:
affiliation: University Hospital Muenster
name: Dominik Bettenworth, Professor, MD
role: PRINCIPAL_INVESTIGATOR
References: