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

December 23, 2020 updated by: Peter Vilmann MD, DSc, HC, FASGE

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Danmark
      • Herlev, Danmark, Denmark, 2730
        • Recruiting
        • Gastro Unit, Division of Endoscopy
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of tissue micro-fragments
Time Frame: 1 month
Comparison of median number of tissue micro-fragments
1 month
Diagnostic tissue area
Time Frame: 1 month
Comparison of total diagnostic tissue area in um2
1 month
Total tissue area
Time Frame: 1 month
Comparison of total total tissue area in um2
1 month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peter Vilmann MD, DSc, HC, FASGE

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2020

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

June 22, 2020

First Submitted That Met QC Criteria

December 23, 2020

First Posted (Actual)

December 29, 2020

Study Record Updates

Last Update Posted (Actual)

December 29, 2020

Last Update Submitted That Met QC Criteria

December 23, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-20006798

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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