Usefulness of Chromoendoscopy in Diagnosing Microscopic Colitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by Karolinska University Hospital
Sponsor:
Information provided by (Responsible Party):
Peter Thelin Schmidt, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01504048
First received: December 29, 2011
Last updated: August 5, 2015
Last verified: August 2015
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Karolinska University Hospital:

Primary Outcome Measures:
  • Detection of microscopic colitis using chromoendoscopy [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: December 29, 2011
Last Updated: August 5, 2015
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Karolinska University Hospital:
Microscopic colitis
Intestinal Diseases
Inflammatory Bowel Diseases

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

ClinicalTrials.gov processed this record on August 27, 2015