Novel Crown-cut Biopsy Needle (FNB) vs Standard Aspiration Needle (FNA) for EUS-guided Diagnosis of SPLs

Pancreas Cancer Clinical Trial

Official title:

Randomized Comparison of Tissue Quality and Molecular Yield Between a Novel Crown-cut Biopsy Needle (FNB) and a Standard Aspiration Needle (FNA) for EUS Guided Diagnosis of Solid Pancreatic Lesions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04687410
• Other study ID #: H-20006798
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: December 2020
• Source: Herlev Hospital
• Contact: Bojan Kovacevic
• Phone: +4538686312
• Email: bojan.kovacevic[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare tissue quality and molecular yield between a novel crown-cut biopsy needle (FNB) and a standard aspiration needle (FNA) for EUS-guided diagnosis of solid pancreatic lesions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: June 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients with a newly discovered SPL scheduled for EUS-guided tissue acquisition who can understand and provide a written consent.

Exclusion Criteria:

• Patients with uncorrected coagulopathies (INR >1.5 or platelet count <50,000) or patients treated with anticoagulants that cannot be discontinued.

• Pregnant or lactating females.

• Interposed, large vessels between the transducer and the target lesion.

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreas Neoplasm
• Pancreatic Neoplasms

Intervention

Device:
• ProControl, MediGlobe
standard 22G FNA needle
• TopGain, Medi-Globe
novel 22G crown-cut FNB needle

Locations

Country	Name	City	State
Denmark	Gastro Unit, Division of Endoscopy	Herlev	Danmark

Sponsors (4)

Lead Sponsor	Collaborator
Peter Vilmann MD, DSc, HC, FASGE	Department of Gastroenterology, Ponderas Academic Hospital Bucharest, Romania, Endoscopy Unit, Odense Hospital, Denmark, Gastro Unit, Endoscopy Section, Hvidovre Hospital, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of tissue micro-fragments	Comparison of median number of tissue micro-fragments	1 month
Primary	Diagnostic tissue area	Comparison of total diagnostic tissue area in um2	1 month
Primary	Total tissue area	Comparison of total total tissue area in um2	1 month
Secondary	Diagnostic yield	diagnostic yield - defined by percentage of diagnostic samples in each group	1 month
Secondary	Diagnostic performance	Sensitivity and specificity, where final diagnosis is either established by subsequent histopathological confirmation or other evidence (clinical, radiological) of malignant disease at a minimum of 12 months of follow-up	12 month
Secondary	Adverse event rate	Comparison of proportions of patients experiencing AE in each group as defined by ASGE's lexicon on adverse events in endoscopy	1 month
Secondary	Mean DNA concentration		6 months
Secondary	Suitability for molecular analyses	Percentage of samples where NGS analysis was successful	6 months