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

• Sponsor: Hôpital Edouard Herriot (Other)
• Overall Status: Completed
• CT.gov ID: NCT04224896
• Collaborator: (none)
• Enrollment: 335
• Actual Duration (Months): 58

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
FRENCH STUDY	Diagnostic Test: UPPER ENDOSCOPY

Study Design

• Study Type: Observational
• Actual Enrollment: 335 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Narrow-Band Imaging (NBI) Versus Lugol Chromoendoscopy in the Detection of Oesophagus Squamous Cell Carcinoma in High Risk Population: a Randomised Controlled Multicentre Trial
• Actual Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: Dec 31, 2015

Arms and Interventions

Arm	Intervention/Treatment
NBI PATIENT	Diagnostic Test: UPPER ENDOSCOPY; UPPER ENDOSCOPY
LUGOL PATIENT	Diagnostic Test: UPPER ENDOSCOPY; UPPER ENDOSCOPY

Outcome Measures

Primary Outcome Measures

1. SPECIFICITY OF THE TWO DIAGNOSTIC STRATEGIES [4 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Patients had a history or current SCC

Exclusion Criteria:

• NONE

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Hôpital Edouard Herriot

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jean Christophe Saurin, Professor, Hôpital Edouard Herriot
• ClinicalTrials.gov Identifier: NCT04224896
• Other Study ID Numbers: SFED
• First Posted: Jan 13, 2020
• Last Update Posted: Jan 13, 2020
• Last Verified: Jan 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma

Study Results

No Results Posted as of Jan 13, 2020