NCT04224896

Brief Summary

Narrow-Band Imaging (NBI) is as sensitive as Lugol chromoendoscopy to detect oesophageal squamous cell carcinoma (SCC) and appears more specific than Lugol chromoendoscopy in expert centres but its specificity in current practice is not known. This study aimed to prove the superiority of NBI specificity over Lugol chromoendoscopy to detect oesophageal SCC and high-grade dysplasia (HGD) in current practice (including tertiary care centres, local hospitals and private clinics).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
335

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2011

Longer than P75 for all trials

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

March 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2015

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

Same day

First QC Date

January 8, 2020

Last Update Submit

January 8, 2020

Conditions

FRENCH STUDY

Outcome Measures

Primary Outcomes (1)

  • SPECIFICITY OF THE TWO DIAGNOSTIC STRATEGIES

    4 years

Study Arms (2)

NBI PATIENT

Diagnostic Test: UPPER ENDOSCOPY

LUGOL PATIENT

Diagnostic Test: UPPER ENDOSCOPY

Interventions

UPPER ENDOSCOPYDIAGNOSTIC_TEST

UPPER ENDOSCOPY

LUGOL PATIENTNBI PATIENT

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HIGH RISK OF OESOPHAGEAL SQUAMOUS CELL CARCINOMA

You may qualify if:

  • Patients had a history or current SCC

You may not qualify if:

  • NONE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Gruner M, Denis A, Masliah C, Amil M, Metivier-Cesbron E, Luet D, Kaasis M, Coron E, Le Rhun M, Lecleire S, Antonietti M, Legoux JL, Lefrou L, Renkes P, Tarreirias AL, Balian P, Rey P, Prost B, Cellier C, Rahmi G, Samaha E, Fratte S, Guerrier B, Landel V, Touzet S, Ponchon T, Pioche M. Narrow-band imaging versus Lugol chromoendoscopy for esophageal squamous cell cancer screening in normal endoscopic practice: randomized controlled trial. Endoscopy. 2021 Jul;53(7):674-682. doi: 10.1055/a-1224-6822. Epub 2020 Oct 1.

    PMID: 32698233DERIVED

MeSH Terms

Interventions

Gastroscopy

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 8, 2020

First Posted

January 13, 2020

Study Start

March 1, 2011

Primary Completion

March 1, 2011

Study Completion

December 31, 2015

Last Updated

January 13, 2020

Record last verified: 2020-01