Usefulness of Chromoendoscopy in Diagnosing Microscopic Colitis

NCT01504048 | Unknown

• 1 other identifier: PTS-02
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Diarrhoea; Lymphocytic Colitis; Collagenous Colitis

Keywords

Microscopic colitis; Intestinal Diseases; Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Chromoendoscopy

EXPERIMENTAL

Procedure: Colonoscopy with Indigo-Carmine Chromoendoscopy

Interventions

Colonoscopy with Indigo-Carmine Chromoendoscopy PROCEDURE

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.

Also known as: Indigo-Carmine

Chromoendoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with chronic non-bloody diarrhea for at least one month

You may not qualify if:

• Patients who decline to participate
• Unable to give informed consent

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Karoliniska University Hospital, Dept. of Gastroenterology

Stockholm, 17176, Sweden

RECRUITING

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Colitis, Lymphocytic; Colitis, Collagenous; Colitis, Microscopic; Intestinal Diseases; Inflammatory Bowel Diseases

Interventions

Colonoscopy; Indigo Carmine

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Peter T Schmidt, MD, PhD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter T Schmidt, MD, PhD

CONTACT

+46 8 51770000; peter.thelin.schmidt@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Endoscopy

Study Record Dates

• First Submitted: December 29, 2011
• First Posted: January 5, 2012
• Study Start: June 1, 2009
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 6, 2015

Record last verified: 2015-08

Locations

SE (1)