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

To assess the feasibility and effectiveness of a program in L-IBD patients using CE targeted biopsies

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Inflammatory Bowel Disease
• Intervention / Treatment: Procedure: Chromoendoscopy

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

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

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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

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	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.	see title	two year

Collaborators and Investigators

• 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

General Publications

• Carballal S, Maisterra S, Lopez-Serrano A, Gimeno-Garcia AZ, Vera MI, Marin-Garbriel JC, Diaz-Tasende J, Marquez L, Alvarez MA, Hernandez L, De Castro L, Gordillo J, Puig I, Vega P, Bustamante-Balen M, Acevedo J, Penas B, Lopez-Ceron M, Ricart E, Cuatrecasas M, Jimeno M, Pellise M; EndoCAR group of the Spanish Gastroenterological Association and Spanish Digestive Endoscopy Society. Real-life chromoendoscopy for neoplasia detection and characterisation in long-standing IBD. Gut. 2018 Jan;67(1):70-78. doi: 10.1136/gutjnl-2016-312332. Epub 2016 Sep 9.

Study record dates

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: Ulcerative Colitis; Crohn disease; Chromoendoscopy; Colorectal Neoplasia
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: 3-Ceron