Improved and Simplified Staining Technique for Dysplasia Detection in Colitis (IST-DDC)

January 16, 2024 updated by: Vastra Gotaland Region

A Prospective Trial Comparing Chromoendoscopy to a Digital Staining Technique and White Light in High Definition Colonoscopy in Patients With IBD Attending Scheduled Surveillance Colonoscopy

Comparing chromoendoscopy to a digital staining technique and White light in patients with IBD attending scheduled surveillance colonoscopy

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In this study we will attempt to compare dye based chromoendoscopy to WLI (white light), NBI( Narrow Band Imaging) and TXI( Texture and Colour Enhancement Imaging). High Definition Colonoscopy is used. We aim to compare all these dye/lights to each other and find the best and simplest method to help to diagnose dysplasia more efficient and easier.

Study Type

Observational

Enrollment (Estimated)

106

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
    • Molndal
      • Gothenburg, Molndal, Sweden, 43180

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Our study is directed to the IBD patients who have to undergo a surveillance colonscopy to early detection of dysplasia.

Description

Inclusion Criteria:

- Person schedules to IBD- surveillance colonoscopy.

Exclusion Criteria:

  • Total Colectomy.
  • Not well prepared Bowel. BBPS under 2 at any segement.
  • Pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dysplasia detection rate
Time Frame: 90 minutes
Dysplasia detection rate for each staining technique
90 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hyperplasia detection rate
Time Frame: 90 minutes
Hyperplasia detection rate for each staining technique
90 minutes
Adenoma detection rate, ADR
Time Frame: 90 minutes
Adenoma detection rate, ADR, for each staining technique
90 minutes
Bowel cleansing quality according to Bowel Boston Preparation Scale
Time Frame: 90 minutes
90 minutes
Serious adverse events (significant bleedings and perforations)
Time Frame: 90 minutes
90 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vastra Gotaland Region

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

January 16, 2024

First Submitted That Met QC Criteria

January 16, 2024

First Posted (Actual)

January 25, 2024

Study Record Updates

Last Update Posted (Actual)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 16, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 281337

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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