Narrow-Band Imaging (NBI) Versus Lugol Chromoendoscopy in the Detection of Oesophagus Squamous Cell Carcinoma in High Risk Population

NCT ID: NCT04224896

Last Updated: 2020-01-13

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

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Recruitment Status

COMPLETED

Total Enrollment

335 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-01

Study Completion Date

2015-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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FRENCH STUDY

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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NBI PATIENT

UPPER ENDOSCOPY

Intervention Type DIAGNOSTIC_TEST

UPPER ENDOSCOPY

LUGOL PATIENT

UPPER ENDOSCOPY

Intervention Type DIAGNOSTIC_TEST

UPPER ENDOSCOPY

Interventions

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UPPER ENDOSCOPY

UPPER ENDOSCOPY

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients had a history or current SCC

Exclusion Criteria

* NONE
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hôpital Edouard Herriot

OTHER

Sponsor Role lead

Responsible Party

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Jean Christophe Saurin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 32698233 (View on PubMed)

Other Identifiers

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SFED

Identifier Type: -

Identifier Source: org_study_id

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