Evaluation of Stricturing Crohn's Disease Using Digital Holographic Microscopy

NCT03465215 | Unknown

• 1 other identifier: 2017-732-f-S
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Assessment of inflammation grade

EXPERIMENTAL

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

Device: Digital holographic microscopy

Interventions

Digital holographic microscopy 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.

Assessment of inflammation grade

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Muenster: lead

Study Sites (1)

Unversity Clinic Muenster

Münster, Germany

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease

Interventions

Quantitative Phase Imaging

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Microscopy, Interference; Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Dominik Bettenworth, Professor, MD

  University Hospital Muenster

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominik Bettenworth, Professor, MD

CONTACT

+492518357935; dominik.bettenworth@ukmuenster.de

Arne Bokemeyer, MD

CONTACT

+492518357935; arne.bokemeyer@ukmuenster.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: March 14, 2018
• Study Start: February 1, 2018
• Primary Completion: February 1, 2020
• Study Completion: August 1, 2020
• Last Updated: March 26, 2018

Record last verified: 2018-03

Locations

DE (1)