Usefulness of Chromoendoscopy in Diagnosing Microscopic Colitis

Sponsor

Karolinska University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01504048

Collaborator

(none)

150

Enrollment

Location

Arm

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Diarrhoea Lymphocytic Colitis Collagenous Colitis	Procedure: Colonoscopy with Indigo-Carmine Chromoendoscopy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Prospective Study on the Usefulness of Chromoendoscopy in Detecting Microscopic Colitis in Patients Undergoing Colonoscopy Due to Chronic Watery Diarrhoea

Study Start Date :

Jun 1, 2009

Anticipated Primary Completion Date :

Jun 1, 2016

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Chromoendoscopy	Procedure: 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. Other Names: Indigo-Carmine

Arm

Intervention/Treatment

Experimental: Chromoendoscopy

Procedure: 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.

Other Names:

Indigo-Carmine

Outcome Measures

Primary Outcome Measures

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.