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

NCT ID: NCT04687410

Last Updated: 2020-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-15

Study Completion Date

2021-06-01

Brief Summary

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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

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Conditions

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Pancreas Neoplasm Pancreas Cancer

Keywords

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fine needle aspiration fine needle biopsy solid pancreatic lesion pancreatic neoplasm pancreatic cancer endoscopic ultrasound EUS-FNA EUS-FNB

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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FNA

Group Type ACTIVE_COMPARATOR

ProControl, MediGlobe

Intervention Type DEVICE

standard 22G FNA needle

FNB

Group Type EXPERIMENTAL

TopGain, Medi-Globe

Intervention Type DEVICE

novel 22G crown-cut FNB needle

Interventions

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ProControl, MediGlobe

standard 22G FNA needle

Intervention Type DEVICE

TopGain, Medi-Globe

novel 22G crown-cut FNB needle

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gastro Unit, Endoscopy Section, Hvidovre Hospital, Denmark

UNKNOWN

Sponsor Role collaborator

Department of Gastroenterology, Ponderas Academic Hospital Bucharest, Romania

UNKNOWN

Sponsor Role collaborator

Endoscopy Unit, Odense Hospital, Denmark

UNKNOWN

Sponsor Role collaborator

Peter Vilmann MD, DSc, HC, FASGE

OTHER

Sponsor Role lead

Responsible Party

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Peter Vilmann MD, DSc, HC, FASGE

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Gastro Unit, Division of Endoscopy

Herlev, Danmark, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Bojan Kovacevic

Role: CONTACT

Phone: +4538686312

Email: [email protected]

Facility Contacts

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Bojan Kovacevic, MD

Role: primary

Other Identifiers

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H-20006798

Identifier Type: -

Identifier Source: org_study_id