Accuracy for Predicting Deep Submucosal Invasion

Summary

The main aim of this study is to determine whether the assessment of the invasive pattern based on NBI with dual focus/magnification or BLI with magnification ± chromoendoscopy (NBI+CE) for predicting deep invasion is significantly more accurate than the assessment based on white light endoscopy (WLE), carried out by trained endoscopists.

Conditions

• Colorectal Cancer
• Colorectal Polyp

Interventions

DIAGNOSTIC_TEST

White light endoscopy (WLE)

Subjective endoscopic assessment of deep submucosal invasion based on the presence of gross morphological malignant features, morphology and size.

DIAGNOSTIC_TEST

NBI/BLI +/- chromoendoscopy (NBIBLI +/- CE)

Endoscopic assessment of deep submucosal invasion with NBI and dual focus/magnification or BLI and magnification. In the case of demarcated areas or JNET 2B, Kudo pit pattern assessment with crystal violet will be performed.

Sponsors & Collaborators

• Hospital Universitario La Fe

  collaborator OTHER

• Hospital Clínico Universitario Lozano Blesa

  collaborator OTHER

• University of North Carolina, Chapel Hill

  collaborator OTHER

• Hospital Clinic of Barcelona

  collaborator OTHER

• National Cancer Center, Japan

  collaborator OTHER_GOV

• Germans Trias i Pujol Hospital

  collaborator OTHER

• Hospital Universitario 12 de Octubre

  collaborator OTHER

• Hospital Universitario Ramon y Cajal

  collaborator OTHER

• San Francisco Veterans Affairs Medical Center

  collaborator FED

• Hospital Universitario Virgen de la Arrixaca

  collaborator OTHER

• Hospital Comarcal de Alcañiz

  collaborator UNKNOWN

• Centro Medico Teknon

  collaborator OTHER

• Althaia Xarxa Assistencial Universitària de Manresa

  lead OTHER

Principal Investigators

• Ignasi Puig, MD, PhD · Althaia Xarxa Assistencial Universitària de Manresa

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-12-01

Primary Completion

2022-09-28

Completion

2022-10-30

Countries

• United States
• Japan
• Spain

Study Locations