Evaluation of Stricturing Crohn's Disease Using Digital Holographic Microscopy

Crohn Disease Clinical Trial

Official title:

Evaluation of Stricturing Crohn's Disease Using Digital Holographic Microscopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03465215
• Other study ID #: 2017-732-f-S
• Status: Recruiting
• Phase: N/A
• First received: March 7, 2018
• Last updated: March 22, 2018
• Start date: February 1, 2018
• Est. completion date: August 1, 2020

Study information

• Verified date: March 2018
• Source: University Hospital Muenster
• Contact: Dominik Bettenworth, Professor, MD
• Phone: +492518357935
• Email: dominik.bettenworth[@]ukmuenster.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 29
• Est. completion date: August 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patients < 18 years

• Pregnancy

• Inability for an informed consent

Related Conditions & MeSH terms

• Crohn Disease
• Inflammatory Bowel Diseases

Intervention

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.

Locations

Country	Name	City	State
Germany	Unversity Clinic Muenster	Münster

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.