Clinical trial NCT03465215: Evaluation of Stricturing Crohn's Disease Using Digital Holographic Microscopy
Official title: Evaluation of Stricturing Crohn's Disease Using Digital Holographic Microscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammatory Bowel Diseases
Crohn Disease
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2018-03-14
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The investigators will include 29 CD patients with a symptomatic intestinal stricture requiring surgery. From these patients, the investigators will collect fullthickness surgical specimen from the non-stenotic and stenotic intestinal wall and will perform analysis using digital holographic microscopy and in histopathological analysis.
Primary purpose: DIAGNOSTIC

Brief summary: Crohn's Disease (CD) patients, belonging to Inflammatory Bowel Disease (IBD), frequently suffer from uncontrolled intestinal inflammation. This can lead to severe disease complications requiring hospitalization. Up to 50% of all CD patients develope intestinal strictures. Intestinal strictures can be subdivided into predominantly inflammatory and predominantly fibrotic types. This subclassification in different types of strictures is important for clinical decision making: patients with predominantly fibrotic strictures would undergo surgery or interventional endoscopic treatment and patients with predominantly inflammatory strictures would be treated anti-inflammatory. To determining the degree of fibrosis and inflammation in CD strictures remains difficult.

Digital holographic microscopy (DHM) is a new imaging approach belonging to the group of quantitative phase imaging. DHM enables stain-free quantitative phase contrast imaging and provides the determination of an refractive index which directly correlated to tissue density.

This study aims to evaluate DHM for assessing the degree of fibrosis and inflammation in surgical specimen from patients with stricturing CD. The investigators collect full thickness surgical resection specimen from 29 patients with symptomatic CD strictures. More detailed, the investigators collect full thickness surgical resection specimen out of stenotic and non-stenotic bowel segments from each patient. For primary purposes, the investigators analyze the obtained tissue using DHM and compare differences of the refractive index, determined by DHM, between stenotic and non-stenotic parts of the intestinal wall. For secondary purposes, the investigators will correlate the findings made by DHM with a detailed analysis by a histopathologist using a scoring system (Goldstandard) to determine the degree of fibrosis and inflammation in the samples.


Eligibility criteria: Inclusion Criteria:

* Patients with a symptomatic intestinal Crohn's Disease stricture requiring surgery

Exclusion Criteria:

* Patients \< 18 years
* Pregnancy
* Inability for an informed consent

Primary outcomes:
measure: Determination of the refractive index for characterising CD strictures
timeFrame: Directly after surgical resection, the investigators obtain fullthickness surgical specimen. Tissue will directly be transported to the laboratory. After processing, the tissue is ready for analysis and will be assessed within a period up to 90 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: