NCT02448693

Brief Summary

This study is designed to evaluate the diagnostic accuracy of Narrow Band Imaging (NBI) compared with High Definition White Light colonoscopy (WLE) for detection of residual neoplasia in subjects with piecemeal polypectomy scars.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

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

May 1, 2015

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 4, 2016

Status Verified

May 1, 2016

Enrollment Period

1 year

First QC Date

May 15, 2015

Last Update Submit

May 3, 2016

Conditions

Colorectal Neoplasms

Keywords

endoscopic mucosal resectionpiecemeal polypectomy scarcolorectal neoplasmsNarrow Band Imagingchromoendoscopy

Outcome Measures

Primary Outcomes (1)

  • Number of residual neoplastic tissue detected with both techniques (NBI versus WLE)

    Efficacy of NBI in detecting residual neoplasia compared with WLE

    less than 1 year after the basal colonoscopy

Secondary Outcomes (2)

  • Number of accurate detection of residual neoplastic tissue with morphologic features in both groups (NBI and WLE) compared with histopathology

    less than 1 year after the basal colonoscopy

  • Number of missed lesions on basal colonoscopy

    less than 1 year after the basal colonoscopy

Study Arms (2)

WLE-NBI

EXPERIMENTAL

Participants will be evaluated by same endoscopist, tandem colonoscopy. It consists of two revisions of the polypectomy scar using firstly High Definition White Light Endoscopy (WLE) and secondly Narrow Band Imaging. All suspected neoplasia will be classified macroscopically and resected and differentiated from both techniques. The rest of the gut will be inspected following conventional standards.

Device: WLEDevice: NBI

NBI-WLE

EXPERIMENTAL

Participants will be evaluated by same endoscopist, tandem colonoscopy. It consists of two revisions of the polypectomy scar using firstly Narrow Band Imaging and secondly High Definition White Light Endoscopy (WLE). All suspected neoplasia will be classified macroscopically and resected and differentiated from both techniques. The rest of the gut will be inspected following conventional standards.

Device: WLEDevice: NBI

Interventions

WLEDEVICE

Evaluation of the polypectomy scar with High Definition White Light Endoscopy (WLE)

Also known as: High Definition colonoscopy with White Light Endoscopy (WLE)
NBI-WLEWLE-NBI
NBIDEVICE

Evaluation of the polypectomy scar with Narrow Band Imaging (NBI, Evis Exera III, Olympus).

Also known as: Narrow Band Imaging
NBI-WLEWLE-NBI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients over 18 years old who underwent a colonoscopy for any reason in the last 12 month
  • Patients with a basal colonoscopy findings: ≥1 polyp removed in a piecemeal fashion regardless of the size

You may not qualify if:

  • Diagnosis of a CRC in the basal colonoscopy
  • Subjects who neglect to follow-up
  • Subjects who do not accept informed consent
  • Subjects with high risk of perforation or complications due to sedation, including patients with comorbidities (ASA IV-V)
  • Inadequate bowel preparation for colonoscopy (defined by Boston Bowel Preparation Score (BBPS): ≤ 5 total points; or 0-1 points in any of the 3 segments of the colon)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

Related Publications (8)

  • Brooker JC, Saunders BP, Shah SG, Thapar CJ, Thomas HJ, Atkin WS, Cardwell CR, Williams CB. Total colonic dye-spray increases the detection of diminutive adenomas during routine colonoscopy: a randomized controlled trial. Gastrointest Endosc. 2002 Sep;56(3):333-8. doi: 10.1016/s0016-5107(02)70034-5.

    PMID: 12196768BACKGROUND

  • Kiesslich R, von Bergh M, Hahn M, Hermann G, Jung M. Chromoendoscopy with indigocarmine improves the detection of adenomatous and nonadenomatous lesions in the colon. Endoscopy. 2001 Dec;33(12):1001-6. doi: 10.1055/s-2001-18932.

    PMID: 11740641BACKGROUND

  • Kaminski MF, Hassan C, Bisschops R, Pohl J, Pellise M, Dekker E, Ignjatovic-Wilson A, Hoffman A, Longcroft-Wheaton G, Heresbach D, Dumonceau JM, East JE. Advanced imaging for detection and differentiation of colorectal neoplasia: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2014 May;46(5):435-49. doi: 10.1055/s-0034-1365348. Epub 2014 Mar 17.

    PMID: 24639382BACKGROUND

  • Khashab M, Eid E, Rusche M, Rex DK. Incidence and predictors of "late" recurrences after endoscopic piecemeal resection of large sessile adenomas. Gastrointest Endosc. 2009 Aug;70(2):344-9. doi: 10.1016/j.gie.2008.10.037. Epub 2009 Feb 27.

    PMID: 19249767BACKGROUND

  • Atkin WS, Valori R, Kuipers EJ, Hoff G, Senore C, Segnan N, Jover R, Schmiegel W, Lambert R, Pox C; International Agency for Research on Cancer. European guidelines for quality assurance in colorectal cancer screening and diagnosis. First Edition--Colonoscopic surveillance following adenoma removal. Endoscopy. 2012 Sep;44 Suppl 3:SE151-63. doi: 10.1055/s-0032-1309821. Epub 2012 Sep 25.

    PMID: 23012119BACKGROUND

  • Lieberman DA, Rex DK, Winawer SJ, Giardiello FM, Johnson DA, Levin TR. Guidelines for colonoscopy surveillance after screening and polypectomy: a consensus update by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2012 Sep;143(3):844-857. doi: 10.1053/j.gastro.2012.06.001. Epub 2012 Jul 3. No abstract available.

    PMID: 22763141BACKGROUND

  • Hurlstone DP, Sanders DS, Cross SS, Adam I, Shorthouse AJ, Brown S, Drew K, Lobo AJ. Colonoscopic resection of lateral spreading tumours: a prospective analysis of endoscopic mucosal resection. Gut. 2004 Sep;53(9):1334-9. doi: 10.1136/gut.2003.036913.

    PMID: 15306595BACKGROUND

  • Rogart JN, Aslanian HR, Siddiqui UD. Narrow band imaging to detect residual or recurrent neoplastic tissue during surveillance endoscopy. Dig Dis Sci. 2011 Feb;56(2):472-8. doi: 10.1007/s10620-010-1289-z. Epub 2010 Jun 9.

    PMID: 20532981BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Narrow Band Imaging

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Optical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Fausto Riu, MD

    Parc de Salut Mar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

May 15, 2015

First Posted

May 19, 2015

Study Start

May 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 4, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)