Usefulness of Chromoendoscopy in Diagnosing Microscopic Colitis
Primary Purpose
Chronic Diarrhoea, Lymphocytic Colitis, Collagenous Colitis
Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Colonoscopy with Indigo-Carmine Chromoendoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Diarrhoea focused on measuring Microscopic colitis, Intestinal Diseases, Inflammatory Bowel Diseases
Eligibility 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
Sites / Locations
- Karoliniska University Hospital, Dept. of GastroenterologyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Chromoendoscopy
Arm Description
Outcomes
Primary Outcome Measures
Detection of microscopic colitis using chromoendoscopy
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01504048
First Posted
December 29, 2011
Last Updated
August 5, 2015
Sponsor
Karolinska University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01504048
Brief Title
Usefulness of Chromoendoscopy in Diagnosing Microscopic Colitis
Official Title
Prospective Study on the Usefulness of Chromoendoscopy in Detecting Microscopic Colitis in Patients Undergoing Colonoscopy Due to Chronic Watery Diarrhoea
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Diarrhoea, Lymphocytic Colitis, Collagenous Colitis
Keywords
Microscopic colitis, Intestinal Diseases, Inflammatory Bowel Diseases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chromoendoscopy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Colonoscopy with Indigo-Carmine Chromoendoscopy
Other Intervention Name(s)
Indigo-Carmine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Detection of microscopic colitis using chromoendoscopy
Description
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.
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter T Schmidt, MD, PhD
Phone
+46 8 51770000
Email
peter.thelin.schmidt@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter T Schmidt, MD, PhD
Organizational Affiliation
Karolinska University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karoliniska University Hospital, Dept. of Gastroenterology
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter T Schmidt, MD, PhD
Phone
+46 8 51770000
Email
peter.thelin.schmidt@ki.se
First Name & Middle Initial & Last Name & Degree
Peter T Schmidt, MD, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
22057822
Citation
Suzuki G, Mellander MR, Suzuki A, Rubio CA, Lambert R, Bjork J, Schmidt PT. Usefulness of colonoscopic examination with indigo carmine in diagnosing microscopic colitis. Endoscopy. 2011 Dec;43(12):1100-4. doi: 10.1055/s-0031-1291423. Epub 2011 Nov 4.
Results Reference
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Learn more about this trial
Usefulness of Chromoendoscopy in Diagnosing Microscopic Colitis
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