Usefulness of Chromoendoscopy for the Early Detection of Colorectal Cancer Associated With Inflammatory Bowel Disease (CE)

September 4, 2015 updated by: Maria Lopez Ceron, Hospital Clinic of Barcelona
To assess the feasibility and effectiveness of a program in L-IBD patients using CE targeted biopsies

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We aim to know the prevalence and incidence of dysplasia and colitis-associated colorectal cancer in patients with longstanding colonic inflammatory bowel disease (N-IBD), in Spain and the usefulness of advanced endoscopy (chromoendoscopy) for the diagnosis and endoscopic differential diagnosis of N-IBD.

Study Type

Observational

Enrollment (Actual)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Hospital Del Mar
      • Barcelona, Spain
        • Hospital de Sant Pau
      • Barcelona, Spain, 08036
        • Gastroenteroly Department, Hospital Clinic
      • Madrid, Spain
        • Hospital Ramon y Cajal
      • Madrid, Spain
        • Hospital 12 de Octubre
      • Madrid, Spain
        • Hospital Puerta del Hierro
      • Tenerife, Spain
        • Hospital Universitario de Canarias
      • Valencia, Spain
        • Hospital de la Fe
      • Valencia, Spain
        • Hospital Peset
    • Barcelona
      • Calella, Barcelona, Spain
        • Hospital Sant Jaume de Calella
      • Hospitalet de Llobregat, Barcelona, Spain
        • Hospital Universitario de Bellvitge
      • Manresa, Barcelona, Spain, 08240
        • Hospital General de Manresa
    • Madrid
      • Mostoles, Madrid, Spain
        • Hospital General de Móstoles
    • Pontevedra
      • Ourense, Pontevedra, Spain, 32005
        • Complexo Hospitalario Universitario de Ourense
      • Vigo, Pontevedra, Spain
        • Complexo Hospitalario Universitario de Vigo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Prospective, multicenter, multicenter study, coordinated by the Department of Gastroenterology, Hospital Clínic of Barcelona

Description

Inclusion Criteria:

  • Diagnosis of UC or colitis EC corroborated by clinical and histology
  • involvement of at least one third of the colon in patients with CD
  • involvement proximal to the rectum in patients with UC
  • Duration of disease > 10 years
  • No clinical activity:
  • May Score <6
  • CDEIS <3.5

Exclusion Criteria:

  • Personal history of CRC
  • colectomy
  • coagulopathy
  • refusal to participate in the study
  • known allergy to indigo carmine
  • colonoscopy in the last 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Inflammatory Bowel Disease

Inflammatory bowel disease (IBD) is comprised of two major disorders: ulcerative colitis and Crohn disease.

Ulcerative colitis is a chronic inflammatory condition characterized by relapsing and remitting episodes of inflammation limited to the mucosal layer of the colon. It almost invariably involves the rectum and typically extends in a proximal and continuous fashion to involve other portions of the colon.

Crohn disease is characterized by transmural inflammation and by skip lesions. The transmural inflammatory nature of Crohn disease may lead to fibrosis and strictures, and to obstructive clinical presentations that are not typically seen in ulcerative colitis. More commonly, the transmural inflammation results in sinus tracts, giving rise to microperforations and fistulae.

Crohn disease may involve the entire gastrointestinal tract from mouth to perianal área patients with long-standing inflammatory bowel disease are prone to the development of colorectal cancer
Procedure: Chromoendoscopy
Chromoendoscopy involves the topical application of stains to improve tissue localization and characterization of lessions during endoscopy . Chromoendoscopy has been used in patients undergoing colonoscopy, including those undergoing surveillance for chronic ulcerative colitis. Using pit pattern classifications, chromoendoscopy has a high sensitivity and specificity for differentiating neoplastic from non-neoplastic lesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence and incidence of dysplasia and colitis-associated colorectal cancer in patients with longstanding colonic inflammatory bowel disease (N-IBD), in Spain
Time Frame: two year
see title
two year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usefulness of advanced endoscopy in displasia characterization (chromoendoscopy ) for the diagnosis and endoscopic differential diagnosis of NIBD.
Time Frame: two year
see title
two year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Collaborators

Hospital Universitario Ramon y Cajal
Hospital del Mar
Hospital Universitario de Canarias
Hospital Universitari de Bellvitge
Hospital Universitario 12 de Octubre
Puerta de Hierro University Hospital
Hospital Universitario La Fe
Hospital Universitario Doctor Peset
Complejo Hospitalario Universitario de Vigo
Hospital de Sant Pau
Complexo Hospitalario de Ourense
Hospital de Manresa
Hospital de Calella
Hospital General de Mostoles

Investigators

  • Principal Investigator: Maria Pellise, MDPHD, Hospital Clinic of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

May 20, 2014

First Submitted That Met QC Criteria

September 4, 2015

First Posted (Estimate)

September 7, 2015

Study Record Updates

Last Update Posted (Estimate)

September 7, 2015

Last Update Submitted That Met QC Criteria

September 4, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-Ceron

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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