Clinical trial NCT02543762: Usefulness of Chromoendoscopy for the Early Detection of Colorectal Cancer Associated With Inflammatory Bowel Disease
Official title: Usefulness of Chromoendoscopy for the Early Detection of Colorectal Cancer Associated With Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Disease
Colorectal Cancer
Keywords: Chromoendoscopy
Ulcerative Colitis
Crohn disease
Colorectal Neoplasia
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Complexo Hospitalario de Ourense
name: Hospital de Manresa
name: Hospital Universitario Ramon y Cajal
name: Hospital Universitario 12 de Octubre
name: Hospital de Calella
name: Hospital General de Mostoles
name: Hospital del Mar
name: Hospital Universitario La Fe
name: Puerta de Hierro University Hospital
name: Hospital Universitario de Canarias
name: Hospital Universitari de Bellvitge
name: Hospital de Sant Pau
name: Complejo Hospitalario Universitario de Vigo
name: Hospital Universitario Doctor Peset
First posted: 2015-09-07
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective, multicenter, multicenter study, coordinated by the Department of Gastroenterology, Hospital Clínic of Barcelona

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence and incidence of dysplasia and colitis-associated colorectal cancer in patients with longstanding colonic inflammatory bowel disease (N-IBD), in Spain
timeFrame: two year
Secondary outcomes:
measure: Usefulness of advanced endoscopy in displasia characterization (chromoendoscopy ) for the diagnosis and endoscopic differential diagnosis of NIBD.
timeFrame: two year
Other outcomes:
Locations:
city: Calella
country: Spain
facility: Hospital Sant Jaume de Calella
state: Barcelona
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitario de Bellvitge
state: Barcelona
city: Manresa
country: Spain
facility: Hospital General de Manresa
state: Barcelona
city: Mostoles
country: Spain
facility: Hospital general de Mostoles
state: Madrid
city: Ourense
country: Spain
facility: Complexo Hospitalario Universitario de Ourense
state: Pontevedra
city: Vigo
country: Spain
facility: Complexo Hospitalario Universitario de Vigo
state: Pontevedra
city: Barcelona
country: Spain
facility: Gastroenteroly Department, Hospital Clinic
city: Barcelona
country: Spain
facility: Hospital de Sant Pau
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Puerta del Hierro
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Tenerife
country: Spain
facility: Hospital Universitario de Canarias
city: Valencia
country: Spain
facility: Hospital de la Fe
city: Valencia
country: Spain
facility: Hospital Peset
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Maria Pellise, MDPHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.