Evaluation of Stricturing Crohn's Disease Using Digital Holographic Microscopy

Not Applicable

• Conditions: Inflammatory Bowel Diseases; Crohn Disease
• Interventions: Device: Digital holographic microscopy

• Registration Number: NCT03465215
• Lead Sponsor: University Hospital Muenster

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-01
• Status Verified: 2018-03
• Study First Submitted: 2018-03-07
• Study First Submitted QC: 2018-03-07
• Study First Posted: 2018-03-14
• Last Update Submitted: 2018-03-22
• Last Update Posted: 2018-03-26
• Primary Completion: 2020-02-01
• Study Completion: 2020-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Assessment of inflammation grade	Digital holographic microscopy	Tissue obtained by CD patients will be analyzed using digital holographic microscopy and comparing histological analysis.

Primary Outcome Measures

Name	Time	Method
Determination of the refractive index for characterising CD strictures	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.

Trial Locations

Locations (1)

Unversity Clinic Muenster; 🇩🇪 Münster, Germany