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Usefulness of Chromoendoscopy in Diagnosing Microscopic Colitis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2015 by Peter Thelin Schmidt, Karolinska University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01504048
First Posted: January 5, 2012
Last Update Posted: August 6, 2015
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.
Information provided by (Responsible Party):
Peter Thelin Schmidt, Karolinska University Hospital
  Purpose
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 Intervention
Chronic Diarrhoea Lymphocytic Colitis Collagenous Colitis Procedure: Colonoscopy with Indigo-Carmine Chromoendoscopy

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Peter Thelin Schmidt, Karolinska University Hospital:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 150
Study Start Date: June 2009
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Indigo-Carmine

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Peter T Schmidt, MD, PhD +46 8 51770000 peter.thelin.schmidt@ki.se

Locations
Sweden
Karoliniska University Hospital, Dept. of Gastroenterology Recruiting
Stockholm, Sweden, 17176
Contact: Peter T Schmidt, MD, PhD    +46 8 51770000    peter.thelin.schmidt@ki.se   
Principal Investigator: Peter T Schmidt, MD, PhD         
Sponsors and Collaborators
Karolinska University Hospital
Investigators
Principal Investigator: Peter T Schmidt, MD, PhD Karolinska University Hospital
  More Information

Publications:
Responsible Party: Peter Thelin Schmidt, Head of Endoscopy, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01504048     History of Changes
Other Study ID Numbers: PTS-02
First Submitted: December 29, 2011
First Posted: January 5, 2012
Last Update Posted: August 6, 2015
Last Verified: August 2015

Keywords provided by Peter Thelin Schmidt, Karolinska University Hospital:
Microscopic colitis
Intestinal Diseases
Inflammatory Bowel Diseases

Additional relevant MeSH terms:
Colitis
Diarrhea
Colitis, Microscopic
Colitis, Collagenous
Colitis, Lymphocytic
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Signs and Symptoms, Digestive
Signs and Symptoms