search
Back to results

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
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Diarrhoea focused on measuring Microscopic colitis, Intestinal Diseases, Inflammatory Bowel Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
December 29, 2011
Last Updated
August 5, 2015
Sponsor
Karolinska University Hospital
search

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
background

Learn more about this trial

Usefulness of Chromoendoscopy in Diagnosing Microscopic Colitis

We'll reach out to this number within 24 hrs