Trial record 1 of 1 for:    NCT01505842
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Chromoendoscopy for Dysplasia Detection in Chronic Inflammatory Bowel Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Karolinska University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Peter Thelin Schmidt, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01505842
First received: December 29, 2011
Last updated: January 4, 2012
Last verified: January 2012
  Purpose

Patients with longstanding ulcerative colitis or crohn's disease in the large bowel have an increased risk of developing cancer. The purpose of this study is to determine if visualizing of the mucosa in details using a dye spray (indigo-carmine) will result in detection of more abnormalities than conventional colonoscopy without dye spray.


Condition Intervention
Ulcerative Colitis
Crohn's Colitis
Procedure: Colonoscopy with Indigo-Carmine chromoendoscopy
Procedure: Conventional white-light colonoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Randomized Controlled Trial (RCT) to Compare Dysplasia Detection Rate in Colonoscopy Without Chromoendoscopy Versus Colonoscopy With Chromoendoscopy in Detecting Dysplasia in Ulcerative Colitis and Crohn's Colitis Patients.

Resource links provided by NLM:


Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • Prevalence of dysplastic lesions [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Number of patients with dysplastic lesions by colonoscopy with chromoendoscopy using Indigo-carmine versus colonoscopy without chromoendoscopy


Secondary Outcome Measures:
  • Number and rate of targeted and non-targeted biopsies detecting dysplasia and non-dysplasia [ Time Frame: 12 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: February 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Colonoscopy with chromoendoscopy
Colonoscopy with chromoendoscopy using 0.2-0.5% Indigo-Carmine solution sprayed in the whole colon and rectum plus 32 random biopsies plus biopsies from suspicious areas
Procedure: Colonoscopy with Indigo-Carmine chromoendoscopy
Colonoscopy with chromoendoscopy using 0.2-0.5% Indigo-Carmine solution sprayed in the whole colon and rectum plus 32 random biopsies plus biopsies from suspicious areas
Other Name: Indigo-Carmine
Active Comparator: Conventional colonoscopy
White light colonoscopy plus 32 random biopsies plus biopsies from suspicious areas
Procedure: Conventional white-light colonoscopy
White light colonoscopy plus 32 random biopsies plus biopsies from suspicious areas

Detailed Description:

Background: Patients with ulcerative colitis and Crohn's colitis are at increased risk of colon cancer. The usefulness of chromoendoscopy is debated. Previous studies are either based on magnifying endoscopy or on non-randomized trials. Some guidelines recommend chromoendoscopy with targeted biopsies and some normal colonoscopy with up to 40 random biopsies.

Chromoendoscopy has the ability to identify subtle lesions that are otherwise missed by standard endoscopy. Whether chromoendoscopy with targeted biopsies can replace standard colonoscopy with random biopsies in the surveillance of patients with chronic colitis is unknown.

Aim: In a RCT in surveillance colonoscopies in patients with ulcerative colitis or Crohn's colitis, we will determine if chromoendoscopy using a dilute solution of Indigo-carmine will improve dysplasia detection rate compared with colonoscopy without chromoendoscopy.

Methods: After informed consent patients undergoing surveillance colonoscopy will be randomized to be examined by the study or control method. The study method will employ a 0.2-0.5% Indigo-Carmine solution sprayed over the colonic and rectal mucosa. The control method will be colonoscopy without Indigo-Carmine chromoendoscopy. In both the study arm and the control arm all subjects will have 32 random biopsies taken (4 from each of 8 defined segments of the colon) and biopsies from suspicious mucosa.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients with ulcerative colitis or Crohn's colitis satisfying criteria for surveillance colonoscopy:

  • Ulcerative colitis, extensive > 8 years OR Crohn's colitis involving ≥ 1/3 of colon/rectum
  • history of PSC or
  • history of previous dysplasia on colon biopsies or
  • family history of colon cancer in first degree relative

Exclusion Criteria:

  • Patients who decline to participate
  • Unable to give informed consent
  • Increased risk of bleeding (i.e. Warfarin, bleeding disorders, Clopidogrel)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01505842

Contacts
Contact: Peter T Schmidt, MD, PhD +46 8 51770000 petthe@ki.se

Locations
Sweden
Karoliniska University Hospital, Dept. of Gastroenterology Recruiting
Stockholm, Sweden, 17176
Principal Investigator: Peter T Schmidt, MD, PhD         
Sponsors and Collaborators
Karolinska University Hospital
Investigators
Principal Investigator: Peter T Schmidt, MD, PhD Karolinska University Hospital
  More Information

No publications provided

Responsible Party: Peter Thelin Schmidt, Head of Endoscopy, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01505842     History of Changes
Other Study ID Numbers: PTS-01
Study First Received: December 29, 2011
Last Updated: January 4, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Karolinska University Hospital:
Ulcerative colitis
Crohn's disease
Chromoendoscopy
Dysplasia
Neoplasia
Inflammatory Bowel Disease

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Inflammatory Bowel Diseases
Ulcer
Colonic Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014