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

Completed

• Conditions: Inflammatory Bowel Disease; Colorectal Cancer
• Interventions: Procedure: Chromoendoscopy

• 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

Arm && Interventions

Group	Intervention	Description
Inflammatory Bowel Disease	Chromoendoscopy	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

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 General de Manresa; 🇪🇸 Manresa, Barcelona, Spain

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

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

Hospital 12 de Octubre; 🇪🇸 Madrid, Spain

Gastroenteroly Department, Hospital Clinic; 🇪🇸 Barcelona, Spain

Hospital de Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Peset; 🇪🇸 Valencia, Spain

Hospital Puerta del Hierro; 🇪🇸 Madrid, Spain

Hospital Ramón y Cajal; 🇪🇸 Madrid, Spain

Hospital Universitario de Canarias; 🇪🇸 Tenerife, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain

Hospital de la Fe; 🇪🇸 Valencia, Spain

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

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