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Evaluation of Stricturing Crohn's Disease Using Digital Holographic Microscopy

Evaluation of Stricturing Crohn's Disease Using Digital Holographic Microscopy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03465215
Enrollment
29
Registered
2018-03-14
Start date
2018-02-01
Completion date
2020-08-01
Last updated
2018-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease, Inflammatory Bowel Diseases

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.

Interventions

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.

Sponsors

University Hospital Muenster
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Determination of the refractive index for characterising CD stricturesDirectly 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.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.

Countries

Germany

Contacts

Primary ContactDominik Bettenworth, Professor, MD
dominik.bettenworth@ukmuenster.de+492518357935
Backup ContactArne Bokemeyer, MD
arne.bokemeyer@ukmuenster.de+492518357935

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026