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

Not Applicable

• Conditions: Pancreas Neoplasm; Pancreas Cancer
• Interventions: Device: ProControl, MediGlobe; Device: TopGain, Medi-Globe

• Registration Number: NCT04687410
• Lead Sponsor: Peter Vilmann MD, DSc, HC, FASGE

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-15
• Study First Submitted: 2020-06-22
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-23
• Last Update Submitted: 2020-12-23
• Study First Posted: 2020-12-29
• Last Update Posted: 2020-12-29
• Primary Completion: 2021-04-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 68

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FNA	ProControl, MediGlobe	-
FNB	TopGain, Medi-Globe	-

Primary Outcome Measures

Name	Time	Method
Amount of tissue micro-fragments	1 month	Comparison of median number of tissue micro-fragments
Total tissue area	1 month	Comparison of total total tissue area in um2
Diagnostic tissue area	1 month	Comparison of total diagnostic tissue area in um2

Secondary Outcome Measures

Name	Time	Method
Suitability for molecular analyses	6 months	Percentage of samples where NGS analysis was successful
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
Mean DNA concentration	6 months
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

Trial Locations

Locations (1)

Gastro Unit, Division of Endoscopy; 🇩🇰 Herlev, Danmark, Denmark