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

Completed

• Conditions: Inflammatory Bowel Disease; Colorectal Cancer

• Registration Number: NCT02543762
• Lead Sponsor: Hospital Clinic 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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2014-05-20
• Primary Completion: 2014-06
• Study Completion: 2015-05
• Status Verified: 2015-09
• Study First Submitted QC: 2015-09-04
• Last Update Submitted: 2015-09-04
• Study First Posted: 2015-09-07
• Last Update Posted: 2015-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence and incidence of dysplasia and colitis-associated colorectal cancer in patients with longstanding colonic inflammatory bowel disease (N-IBD), in Spain	two year	see title

Secondary Outcome Measures

Name	Time	Method
Usefulness of advanced endoscopy in displasia characterization (chromoendoscopy ) for the diagnosis and endoscopic differential diagnosis of NIBD.	two year	see title

Trial Locations

Locations (15)

Hospital Sant Jaume de Calella; 🇪🇸 Calella, Barcelona, Spain

Hospital Universitario de Bellvitge; 🇪🇸 Hospitalet de Llobregat, Barcelona, Spain

Hospital General de Manresa; 🇪🇸 Manresa, Barcelona, Spain

Hospital general de Mostoles; 🇪🇸 Mostoles, Madrid, Spain

Complexo Hospitalario Universitario de Ourense; 🇪🇸 Ourense, Pontevedra, Spain

Complexo Hospitalario Universitario de Vigo; 🇪🇸 Vigo, Pontevedra, Spain

Gastroenteroly Department, Hospital Clinic; 🇪🇸 Barcelona, Spain

Hospital de Sant Pau; 🇪🇸 Barcelona, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain

Hospital 12 de Octubre; 🇪🇸 Madrid, Spain

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