Evaluation of Stricturing Crohn's Disease Using Digital Holographic Microscopy

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 Overview

• Status: Unknown
• Conditions: Inflammatory Bowel Diseases; Crohn Disease
• Intervention / Treatment: Device: Digital holographic microscopy

• Study Type: Interventional
• Enrollment (Anticipated): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Münster, Germany
    • Recruiting
    • Unversity Clinic Muenster
    • Contact: Dominik Bettenworth, Professor, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Assessment of inflammation grade; Tissue obtained by CD patients will be analyzed using digital holographic microscopy and comparing histological analysis.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of the refractive index for characterising CD strictures	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.	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.

Collaborators and Investigators

• Sponsor: University Hospital Muenster
• Investigators: Principal Investigator: Dominik Bettenworth, Professor, MD, University hospital Muenster

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Anticipated): February 1, 2020
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: March 7, 2018
• First Submitted That Met QC Criteria: March 7, 2018
• First Posted (Actual): March 14, 2018

Study Record Updates

• Last Update Posted (Actual): March 26, 2018
• Last Update Submitted That Met QC Criteria: March 22, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: 2017-732-f-S

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No