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Evaluation of Stricturing Crohn's Disease Using Digital Holographic Microscopy

Primary Purpose

Inflammatory Bowel Diseases, Crohn Disease

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Digital holographic microscopy
Sponsored by
University Hospital Muenster
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Inflammatory Bowel Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Unversity Clinic MuensterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Assessment of inflammation grade

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 7, 2018
Last Updated
March 22, 2018
Sponsor
University Hospital Muenster
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1. Study Identification

Unique Protocol Identification Number
NCT03465215
Brief Title
Evaluation of Stricturing Crohn's Disease Using Digital Holographic Microscopy
Official Title
Evaluation of Stricturing Crohn's Disease Using Digital Holographic Microscopy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
February 1, 2020 (Anticipated)
Study Completion Date
August 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Muenster

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Crohn Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Assessment of inflammation grade
Arm Type
Experimental
Arm Description
Tissue obtained by CD patients will be analyzed using digital holographic microscopy and comparing histological analysis.
Intervention Type
Device
Intervention Name(s)
Digital holographic microscopy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Determination of the refractive index for characterising CD strictures
Description
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.
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dominik Bettenworth, Professor, MD
Phone
+492518357935
Email
dominik.bettenworth@ukmuenster.de
First Name & Middle Initial & Last Name or Official Title & Degree
Arne Bokemeyer, MD
Phone
+492518357935
Email
arne.bokemeyer@ukmuenster.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominik Bettenworth, Professor, MD
Organizational Affiliation
University Hospital Muenster
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unversity Clinic Muenster
City
Münster
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominik Bettenworth, Professor, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Evaluation of Stricturing Crohn's Disease Using Digital Holographic Microscopy

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