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Clinical Trials/NCT03465215
NCT03465215UnknownNot Applicable

Evaluation of Stricturing Crohn's Disease Using Digital Holographic Microscopy

University Hospital Muenster1 site in 1 country29 target enrollmentStarted: February 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
29
Locations
1
Primary Endpoint
Determination of the refractive index for characterising CD strictures

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Patients < 18 years
  • Pregnancy
  • Inability for an informed consent

Arms & Interventions

Assessment of inflammation grade

Experimental

Tissue obtained by CD patients will be analyzed using digital holographic microscopy and comparing histological analysis.

Intervention: Digital holographic microscopy (Device)

Outcomes

Primary Outcomes

Determination of the refractive index for characterising CD strictures

Time Frame: 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.

Obtained intestinal tissue (non-stenotic and stenotic) tissue will be analyzed using digital holographic microscopy (DHM). DHM provides a refractive index which will be compared between non-stenotic and stenotic tissue.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University Hospital Muenster
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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