Usefulness of Chromoendoscopy in Diagnosing Microscopic Colitis

NCT01504048 — Not applicable, Unknown, 150 participants, Karolinska University Hospital

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

Registry	NCT01504048
Status	Unknown
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, diagnostic
Enrollment	150 (Estimated)
Sponsor	Karolinska University Hospital (Other)
Conditions	Chronic Diarrhoea, Lymphocytic Colitis, Collagenous Colitis
Interventions	Colonoscopy with Indigo-Carmine Chromoendoscopy (Procedure)
Dates	start 2009-06-01, primary completion 2016-06-01 (estimated), completion 2016-12-01 (estimated), first posted 2012-01-05, last updated 2015-08-06
Locations	1 site in Sweden

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Chromoendoscopy	Experimental	Procedure: Colonoscopy with Indigo-Carmine Chromoendoscopy

Colonoscopy with Indigo-Carmine Chromoendoscopy (Procedure), also known as Indigo-Carmine: 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.

+Outcome measures

Primary outcomes

Detection of microscopic colitis using chromoendoscopy [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.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Karoliniska University Hospital, Dept. of Gastroenterology	Stockholm	Sweden	Recruiting

+Publications

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. PMID 22057822

+Investigators

Peter T Schmidt, MD, PhD, Principal investigator, Karolinska University Hospital