Usefulness of Chromoendoscopy in Diagnosing Microscopic Colitis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01504048|
Recruitment Status : Unknown
Verified August 2015 by Peter Thelin Schmidt, Karolinska University Hospital.
Recruitment status was: Recruiting
First Posted : January 5, 2012
Last Update Posted : August 6, 2015
|Condition or disease||Intervention/treatment||Phase|
|Chronic Diarrhoea Lymphocytic Colitis Collagenous Colitis||Procedure: Colonoscopy with Indigo-Carmine Chromoendoscopy||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||June 2009|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||December 2016|
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 Name: Indigo-Carmine
- Detection of microscopic colitis using chromoendoscopy [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01504048
|Contact: Peter T Schmidt, MD, PhD||+46 8 email@example.com|
|Karoliniska University Hospital, Dept. of Gastroenterology||Recruiting|
|Stockholm, Sweden, 17176|
|Contact: Peter T Schmidt, MD, PhD +46 8 51770000 firstname.lastname@example.org|
|Principal Investigator: Peter T Schmidt, MD, PhD|
|Principal Investigator:||Peter T Schmidt, MD, PhD||Karolinska University Hospital|