NCT04687410

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2020

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 29, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

December 29, 2020

Status Verified

December 1, 2020

Enrollment Period

10 months

First QC Date

June 22, 2020

Last Update Submit

December 23, 2020

Conditions

Pancreas NeoplasmPancreas Cancer

Keywords

fine needle aspirationfine needle biopsysolid pancreatic lesionpancreatic neoplasmpancreatic cancerendoscopic ultrasoundEUS-FNAEUS-FNB

Outcome Measures

Primary Outcomes (3)

  • Amount of tissue micro-fragments

    Comparison of median number of tissue micro-fragments

    1 month

  • Diagnostic tissue area

    Comparison of total diagnostic tissue area in um2

    1 month

  • Total tissue area

    Comparison of total total tissue area in um2

    1 month

Secondary Outcomes (5)

  • Diagnostic yield

    1 month

  • Diagnostic performance

    12 month

  • Adverse event rate

    1 month

  • Mean DNA concentration

    6 months

  • Suitability for molecular analyses

    6 months

Study Arms (2)

FNA

ACTIVE COMPARATOR
Device: ProControl, MediGlobe

FNB

EXPERIMENTAL
Device: TopGain, Medi-Globe

Interventions

ProControl, MediGlobeDEVICE

standard 22G FNA needle

FNA
TopGain, Medi-GlobeDEVICE

novel 22G crown-cut FNB needle

FNB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gastro Unit, Division of Endoscopy

Herlev, Danmark, 2730, Denmark

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Central Study Contacts

Bojan Kovacevic

CONTACT

+4538686312bojan.kovacevic@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 22, 2020

First Posted

December 29, 2020

Study Start

June 15, 2020

Primary Completion

April 1, 2021

Study Completion

June 1, 2021

Last Updated

December 29, 2020

Record last verified: 2020-12

Locations

DK(1)