Usefulness of Chromoendoscopy for the Early Detection of Colorectal Cancer Associated With Inflammatory Bowel Disease
NCT ID: NCT02543762
Last Updated: 2015-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
350 participants
OBSERVATIONAL
2012-02-29
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* colectomy
* coagulopathy
* refusal to participate in the study
* known allergy to indigo carmine
* colonoscopy in the last 6 months
18 Years
ALL
No
Sponsors
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Complexo Hospitalario de Ourense
OTHER
Hospital de Manresa
UNKNOWN
Hospital Universitario Ramon y Cajal
OTHER
Hospital Universitario 12 de Octubre
OTHER
Hospital de Calella
OTHER
Hospital General de Mostoles
OTHER
Hospital del Mar
OTHER
Hospital Universitario La Fe
OTHER
Puerta de Hierro University Hospital
OTHER
Hospital Universitario de Canarias
OTHER
Hospital Universitari de Bellvitge
OTHER
Hospital de Sant Pau
OTHER
Complejo Hospitalario Universitario de Vigo
OTHER
Hospital Universitario Doctor Peset
OTHER
Hospital Clinic of Barcelona
OTHER
Responsible Party
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Maria Lopez Ceron
MDPHD
Principal Investigators
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Maria Pellise, MDPHD
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic of Barcelona
Locations
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Gastroenteroly Department, Hospital Clinic
Barcelona, Barcelona, Spain
Hospital de Sant Pau
Barcelona, Barcelona, Spain
Hospital del Mar
Barcelona, Barcelona, Spain
Hospital Sant Jaume de Calella
Calella, Barcelona, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital General de Manresa
Manresa, Barcelona, Spain
Hospital 12 de Octubre
Madrid, Madrid, Spain
Hospital Puerta del Hierro
Madrid, Madrid, Spain
Hospital Ramón y Cajal
Madrid, Madrid, Spain
Hospital general de Mostoles
Móstoles, Madrid, Spain
Complexo Hospitalario Universitario de Ourense
Ourense, Pontevedra, Spain
Complexo Hospitalario Universitario de Vigo
Vigo, Pontevedra, Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Tenerife, Spain
Hospital de la Fe
Valencia, Valencia, Spain
Hospital Peset
Valencia, Valencia, Spain
Countries
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References
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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.
Other Identifiers
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3-Ceron
Identifier Type: -
Identifier Source: org_study_id
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