Usefulness of Chromoendoscopy in Diagnosing Microscopic Colitis

Collagenous Colitis Clinical Trial

Official title:

Prospective Study on the Usefulness of Chromoendoscopy in Detecting Microscopic Colitis in Patients Undergoing Colonoscopy Due to Chronic Watery Diarrhoea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01504048
• Other study ID #: PTS-02
• Status: Recruiting
• Phase: N/A
• First received: December 29, 2011
• Last updated: August 5, 2015
• Start date: June 2009
• Est. completion date: December 2016

Study information

• Verified date: August 2015
• Source: Karolinska University Hospital
• Contact: Peter T Schmidt, MD, PhD
• Phone: +46 8 51770000
• Email: peter.thelin.schmidt[@]ki.se
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chronic Diarrhoea
• Colitis
• Colitis, Microscopic
• Collagenous Colitis
• Diarrhea
• Lymphocytic Colitis

Intervention

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.

Locations

Country	Name	City	State
Sweden	Karoliniska University Hospital, Dept. of Gastroenterology	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Suzuki G, Mellander MR, Suzuki A, Rubio CA, Lambert R, Björk 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 month	No