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

Colorectal Cancer Clinical Trial

— CE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02543762
• Other study ID #: 3-Ceron
• Status: Completed
• Phase: N/A
• First received: May 20, 2014
• Last updated: September 4, 2015
• Start date: February 2012
• Est. completion date: May 2015

Study information

• Verified date: September 2015
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: May 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Spain	Gastroenteroly Department, Hospital Clinic	Barcelona
Spain	Hospital de Sant Pau	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Sant Jaume de Calella	Calella	Barcelona
Spain	Hospital Universitario de Bellvitge	Hospitalet de Llobregat	Barcelona
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital Puerta del Hierro	Madrid
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital General de Manresa	Manresa	Barcelona
Spain	Hospital general de Mostoles	Mostoles	Madrid
Spain	Complexo Hospitalario Universitario de Ourense	Ourense	Pontevedra
Spain	Hospital Universitario de Canarias	Tenerife
Spain	Hospital de la Fe	Valencia
Spain	Hospital Peset	Valencia
Spain	Complexo Hospitalario Universitario de Vigo	Vigo	Pontevedra

Sponsors (15)

Lead Sponsor

Collaborator

Hospital Clinic of Barcelona

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence and incidence of dysplasia and colitis-associated colorectal cancer in patients with longstanding colonic inflammatory bowel disease (N-IBD), in Spain	see title	two year	No
Secondary	Usefulness of advanced endoscopy in displasia characterization (chromoendoscopy ) for the diagnosis and endoscopic differential diagnosis of NIBD.	see title	two year	No