NCT02543762

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2012

Typical duration for all trials

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2014

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 7, 2015

Completed
Last Updated

September 7, 2015

Status Verified

September 1, 2015

Enrollment Period

2.3 years

First QC Date

May 20, 2014

Last Update Submit

September 4, 2015

Conditions

Inflammatory Bowel DiseaseColorectal Cancer

Keywords

ChromoendoscopyUlcerative ColitisCrohn diseaseColorectal Neoplasia

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

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

    two year

Study Arms (1)

Inflammatory Bowel Disease

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

Procedure: Chromoendoscopy

Interventions

ChromoendoscopyPROCEDURE

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

Inflammatory Bowel Disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Prospective, multicenter, multicenter study, coordinated by the Department of Gastroenterology, Hospital Clínic of Barcelona

You may qualify if:

  • 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

You may not qualify if:

  • Personal history of CRC
  • colectomy
  • coagulopathy
  • refusal to participate in the study
  • known allergy to indigo carmine
  • colonoscopy in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Gastroenteroly Department, Hospital Clinic

Barcelona, Barcelona, 08036, Spain

Location

Hospital de Sant Pau

Barcelona, Barcelona, Spain

Location

Hospital del Mar

Barcelona, Barcelona, Spain

Location

Hospital Sant Jaume de Calella

Calella, Barcelona, Spain

Location

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Location

Hospital General de Manresa

Manresa, Barcelona, 08240, Spain

Location

Hospital 12 de Octubre

Madrid, Madrid, Spain

Location

Hospital Puerta del Hierro

Madrid, Madrid, Spain

Location

Hospital Ramón y Cajal

Madrid, Madrid, Spain

Location

Hospital general de Mostoles

Móstoles, Madrid, Spain

Location

Complexo Hospitalario Universitario de Ourense

Ourense, Pontevedra, 32005, Spain

Location

Complexo Hospitalario Universitario de Vigo

Vigo, Pontevedra, Spain

Location

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Tenerife, Spain

Location

Hospital de la Fe

Valencia, Valencia, Spain

Location

Hospital Peset

Valencia, Valencia, Spain

Location

Related Publications (1)

  • 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.

    PMID: 27612488DERIVED

MeSH Terms

Conditions

Inflammatory Bowel DiseasesColorectal NeoplasmsColitis, UlcerativeCrohn Disease

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsColonic DiseasesRectal DiseasesColitis

Study Officials

  • Maria Pellise, MDPHD

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MDPHD

Study Record Dates

First Submitted

May 20, 2014

First Posted

September 7, 2015

Study Start

February 1, 2012

Primary Completion

June 1, 2014

Study Completion

May 1, 2015

Last Updated

September 7, 2015

Record last verified: 2015-09

Locations

ES(15)