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

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

Completed

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Key information

Conditions

Inflammatory Bowel Disease Colitis Colitis, Ulcerative Colonic Diseases Colorectal Cancer Colorectal Neoplasms Crohn Disease Digestive System Diseases Digestive System Neoplasms Gastroenteritis Gastrointestinal Diseases Gastrointestinal Neoplasms Inflammatory Bowel Diseases Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gastroenteroly Department, Hospital Clinic, Barcelona, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

chromoendoscopy

Procedure

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

Primary outcomes

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

Secondary outcomes

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

Time frame: two year

see title

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Collaborators

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

Registry information

Acronym: CE

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2015
First posted: Sep 7, 2015
Registry last updated: Sep 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed