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

Sponsor

Peter Vilmann MD, DSc, HC, FASGE (Other)

Overall Status

Recruiting

CT.gov ID

NCT04687410

Collaborator

Gastro Unit, Endoscopy Section, Hvidovre Hospital, Denmark (Other), Department of Gastroenterology, Ponderas Academic Hospital Bucharest, Romania (Other), Endoscopy Unit, Odense Hospital, Denmark (Other)

Enrollment

Location

Arms

11.5

Anticipated Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pancreas Neoplasm Pancreas Cancer	Device: ProControl, MediGlobe Device: TopGain, Medi-Globe	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Diagnostic

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

Actual Study Start Date :

Jun 15, 2020

Anticipated Primary Completion Date :

Apr 1, 2021

Anticipated Study Completion Date :

Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: FNA	Device: ProControl, MediGlobe standard 22G FNA needle
Experimental: FNB	Device: TopGain, Medi-Globe novel 22G crown-cut FNB needle

Arm

Intervention/Treatment

Active Comparator: FNA

Device: ProControl, MediGlobe

standard 22G FNA needle

Experimental: FNB

Device: TopGain, Medi-Globe

novel 22G crown-cut FNB needle

Outcome Measures

Primary Outcome Measures

Amount of tissue micro-fragments [1 month]
Comparison of median number of tissue micro-fragments
Diagnostic tissue area [1 month]
Comparison of total diagnostic tissue area in um2
Total tissue area [1 month]
Comparison of total total tissue area in um2

Secondary Outcome Measures

Diagnostic yield [1 month]
diagnostic yield - defined by percentage of diagnostic samples in each group
Diagnostic performance [12 month]
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
Adverse event rate [1 month]
Comparison of proportions of patients experiencing AE in each group as defined by ASGE's lexicon on adverse events in endoscopy
Mean DNA concentration [6 months]
Suitability for molecular analyses [6 months]
Percentage of samples where NGS analysis was successful

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.