Evaluation of Stricturing Crohn's Disease Using Digital Holographic Microscopy

NCT ID: NCT03465215

Last Updated: 2018-03-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2020-08-01

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.

Conditions

Inflammatory Bowel Diseases; Crohn Disease

Study Design

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

Study Groups

Assessment of inflammation grade

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

Group Type: EXPERIMENTAL

Digital holographic microscopy

Intervention Type: DEVICE

Tissue obtained from CD patients will be analyzed using digital holographic microscopy. Results will be compared between non-stenotic and stenotic tissue of the intestinal wall of CD patients.

Interventions

Digital holographic microscopy

Tissue obtained from CD patients will be analyzed using digital holographic microscopy. Results will be compared between non-stenotic and stenotic tissue of the intestinal wall of CD patients.

Intervention Type: DEVICE

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

• 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, Professor, MD

Role: primary

Other Identifiers

2017-732-f-S

Identifier Type: -

Identifier Source: org_study_id