Usefulness of Chromoendoscopy in Diagnosing Microscopic Colitis

NCT ID: NCT01504048

Last Updated: 2015-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2016-12-31

Brief Summary

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The purpose of this study is to determine whether chromoendoscopy using Indigo-Carmine dye spray is useful in diagnosing microscopic colitis among patients undergoing colonoscopy due to chronic watery diarrhea.

Detailed Description

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Microscopic colitis is a common disease found in 10% to 20% of cases having chronic watery diarrhea. Obvious endoscopically identifiable changes of the mucosal surface are usually absent, thus diagnosing microscopic colitis relies on multiple biopsy sampling from all segments of the colon. Chromoendoscopy using indigo-carmine dye spray might, however, unravel mucosal changes in microscopic colitis (Suzuki 2011).

The aim of this study is to investigate if chromoendoscopy using Indigo-Carmine 0.2-0.5% in patients with chronic watery diarrhea is useful in diagnosing microscopic colitis.

Conditions

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Chronic Diarrhoea Lymphocytic Colitis Collagenous Colitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Chromoendoscopy

Group Type EXPERIMENTAL

Colonoscopy with Indigo-Carmine Chromoendoscopy

Intervention Type PROCEDURE

Colonoscopy with chromoendoscopy using 0.2-0.5% Indigo-Carmine solution sprayed in five areas of the large intestine: Cecum, ascending colon, transverse colon, descending colon and rectum. Pictures are taken before and after dye-spraying and biopsies are collected from all segments of the large intestine and rectum.

Interventions

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Colonoscopy with Indigo-Carmine Chromoendoscopy

Colonoscopy with chromoendoscopy using 0.2-0.5% Indigo-Carmine solution sprayed in five areas of the large intestine: Cecum, ascending colon, transverse colon, descending colon and rectum. Pictures are taken before and after dye-spraying and biopsies are collected from all segments of the large intestine and rectum.

Intervention Type PROCEDURE

Other Intervention Names

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Indigo-Carmine

Eligibility Criteria

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Inclusion Criteria

* Patients with chronic non-bloody diarrhea for at least one month

Exclusion Criteria

* Patients who decline to participate
* Unable to give informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Peter Thelin Schmidt

Head of Endoscopy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter T Schmidt, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Locations

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Karoliniska University Hospital, Dept. of Gastroenterology

Stockholm, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Peter T Schmidt, MD, PhD

Role: CONTACT

+46 8 51770000

Facility Contacts

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Peter T Schmidt, MD, PhD

Role: primary

+46 8 51770000

References

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Suzuki G, Mellander MR, Suzuki A, Rubio CA, Lambert R, Bjork J, Schmidt PT. Usefulness of colonoscopic examination with indigo carmine in diagnosing microscopic colitis. Endoscopy. 2011 Dec;43(12):1100-4. doi: 10.1055/s-0031-1291423. Epub 2011 Nov 4.

Reference Type BACKGROUND
PMID: 22057822 (View on PubMed)

Other Identifiers

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PTS-02

Identifier Type: -

Identifier Source: org_study_id

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