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CompletedNCT02543762CEUpdated Sep 7, 2015

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

An observational study in Inflammatory Bowel Disease and Colorectal Cancer, sponsored by Hospital Clinic of Barcelona. Completed at 15 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-09-07.

Sponsored by Hospital Clinic of Barcelona · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
350
Ages
18 Years and older
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Inflammatory Bowel Disease
  • Colorectal Cancer

Keywords

  • Chromoendoscopy
  • Ulcerative Colitis
  • Crohn disease
  • Colorectal Neoplasia
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In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 350 is above the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Hospital Clinic of Barcelona is the lead sponsor of 319 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
350 participants (actual)
Target follow-up
2 Years
Patient registry
Yes

Groups and cohorts

  • 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

Interventions

  • ProcedureChromoendoscopy

    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

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What researchers measure

Primary outcomes

  1. Prevalence and incidence of dysplasia and colitis-associated colorectal cancer in patients with longstanding colonic inflammatory bowel disease (N-IBD), in Spain

    see title

    Time frame: two year

Secondary outcomes

  1. Usefulness of advanced endoscopy in displasia characterization (chromoendoscopy ) for the diagnosis and endoscopic differential diagnosis of NIBD.

    see title

    Time frame: two year

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Study locations

15 sites
  • Hospital Sant Jaume de Calella
    Calella, Barcelona, Spain
  • Hospital Universitario de Bellvitge
    Hospitalet de Llobregat, Barcelona, Spain
  • Hospital General de Manresa
    Manresa, Barcelona 08240, Spain
  • Hospital general de Mostoles
    Mostoles, Madrid, Spain
  • Complexo Hospitalario Universitario de Ourense
    Ourense, Pontevedra 32005, Spain
  • Complexo Hospitalario Universitario de Vigo
    Vigo, Pontevedra, Spain
  • Gastroenteroly Department, Hospital Clinic
    Barcelona, 08036, Spain
  • Hospital de Sant Pau
    Barcelona, Spain
  • Hospital del Mar
    Barcelona, Spain
  • Hospital 12 de Octubre
    Madrid, Spain
  • Hospital Puerta del Hierro
    Madrid, Spain
  • Hospital Ramón y Cajal
    Madrid, Spain
  • Hospital Universitario de Canarias
    Tenerife, Spain
  • Hospital de la Fe
    Valencia, Spain
  • Hospital Peset
    Valencia, Spain
08

References and documents

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. PubMed 27612488 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02543762
Lead sponsor
Hospital Clinic of Barcelona
Collaborators
Complexo Hospitalario de Ourense, Hospital de Manresa, Hospital Universitario Ramon y Cajal, Hospital Universitario 12 de Octubre, Hospital de Calella, Hospital General de Mostoles, Hospital del Mar, Hospital Universitario La Fe, Puerta de Hierro University Hospital, Hospital Universitario de Canarias, Hospital Universitari de Bellvitge, Hospital de Sant Pau, Complejo Hospitalario Universitario de Vigo, Hospital Universitario Doctor Peset
Responsible party
Maria Lopez Ceron (MDPHD, Hospital Clinic of Barcelona) — Principal investigator
First posted
Sep 7, 2015
Start date
Feb 2012
Primary completion
Jun 2014
Completion
May 2015
Last update
Sep 7, 2015

Study contacts

Maria Pellise, MDPHD
principal investigator · Hospital Clinic of Barcelona

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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