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

FRENCH STUDY Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04224896
• Other study ID #: SFED
• Status: Completed
• Start date: March 1, 2011
• Est. completion date: December 31, 2015

Study information

• Verified date: January 2020
• Source: Hôpital Edouard Herriot
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 335
• Est. completion date: December 31, 2015
• Est. primary completion date: March 1, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients had a history or current SCC

Exclusion Criteria:

• NONE

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma
• FRENCH STUDY

Intervention

Diagnostic Test:
• UPPER ENDOSCOPY
UPPER ENDOSCOPY

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Edouard Herriot

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SPECIFICITY OF THE TWO DIAGNOSTIC STRATEGIES		4 years