Usefulness of Chromoendoscopy in Diagnosing Microscopic Colitis

Not Applicable

• Conditions: Lymphocytic Colitis; Chronic Diarrhoea; Collagenous Colitis
• Interventions: Procedure: Colonoscopy with Indigo-Carmine Chromoendoscopy

• Registration Number: NCT01504048
• Lead Sponsor: Karolinska University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2011-12-29
• Study First Submitted QC: 2012-01-04
• Study First Posted: 2012-01-05
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-05
• Last Update Posted: 2015-08-06
• Primary Completion: 2016-06
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chromoendoscopy	Colonoscopy with Indigo-Carmine Chromoendoscopy	-

Primary Outcome Measures

Name	Time	Method
Detection of microscopic colitis using chromoendoscopy	12 month	To investigate the usefullness of chromoendoscopy in diagnosing microscopic colitis using 0.2-0.5% Indigo-Carmine dye spray. The golden standard is the results of histological examination of biopsies from the colo-rectal mucosa.

Trial Locations

Locations (1)

Karoliniska University Hospital, Dept. of Gastroenterology; 🇸🇪 Stockholm, Sweden