Narrow Band Imaging Versus White Light for Colonoscopy Serrate Lesions Detection

NCT ID: NCT02876133

Last Updated: 2018-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

987 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2019-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Colorectal cancer (CRC) is a leading cause of cancer death and its' incidence is rising in most European countries. Colonoscopy has been shown to reduce CRC incidence, however its effectiveness depends on the sensitivity to detect pre-malignant lesions.

Our aim is to evaluate narrow band imaging (NBI) during colonoscopy and serum miRNAs as novel tools for the early detection of colonic sessile serrated lesions (SSL). The investigators will perform a multicenter-randomized-controlled-trial to study the role of NBI in SSL detection.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colon Cancer Colon Sessile Serrated Adenoma/Polyp

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Narrow band imaging withdrawal

colonoscope withdrawal and mucosal inspection performed under narrow band imaging

Group Type EXPERIMENTAL

narrow band imaging withdrawal

Intervention Type DEVICE

colonoscope withdrawal and mucosal inspection performed under narrow band imaging

white light withdrawal

colonoscope withdrawal and mucosal inspection performed under white light imaging

Group Type PLACEBO_COMPARATOR

white light withdrawal

Intervention Type DEVICE

colonoscope withdrawal and mucosal inspection performed under white light imaging

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

narrow band imaging withdrawal

colonoscope withdrawal and mucosal inspection performed under narrow band imaging

Intervention Type DEVICE

white light withdrawal

colonoscope withdrawal and mucosal inspection performed under white light imaging

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients scheduled for elective colonoscopies

Exclusion Criteria

* known polyposis syndromes
* primary sclerosing cholangitis
* inflammatory bowel disease
* personal colorectal cancer history
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital Beatriz Ângelo

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Alexandre Ferreira

Gastroenterologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alexandre O Ferreira, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Beatriz Ângelo

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Beatriz Ângelo

Loures, , Portugal

Site Status RECRUITING

Centro Hospitalar do Porto

Porto, , Portugal

Site Status NOT_YET_RECRUITING

Instituto Português de Oncologia do Porto

Porto, , Portugal

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Portugal

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Alexandre O Ferreira, MD

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Alexandre O Ferreira, MD

Role: primary

Ricardo M Pinto, MD, PhD

Role: primary

Mario D Ribeiro, MD, PhD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Rex DK, Ahnen DJ, Baron JA, Batts KP, Burke CA, Burt RW, Goldblum JR, Guillem JG, Kahi CJ, Kalady MF, O'Brien MJ, Odze RD, Ogino S, Parry S, Snover DC, Torlakovic EE, Wise PE, Young J, Church J. Serrated lesions of the colorectum: review and recommendations from an expert panel. Am J Gastroenterol. 2012 Sep;107(9):1315-29; quiz 1314, 1330. doi: 10.1038/ajg.2012.161. Epub 2012 Jun 19.

Reference Type BACKGROUND
PMID: 22710576 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

176

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.