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

Primary Purpose

Pancreas Neoplasm, Pancreas Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
ProControl, MediGlobe
TopGain, Medi-Globe
Sponsored by
Peter Vilmann MD, DSc, HC, FASGE
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pancreas Neoplasm focused on measuring fine needle aspiration, fine needle biopsy, solid pancreatic lesion, pancreatic neoplasm, pancreatic cancer, endoscopic ultrasound, EUS-FNA, EUS-FNB

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Gastro Unit, Division of EndoscopyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

FNA

FNB

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 22, 2020
Last Updated
December 23, 2020
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
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1. Study Identification

Unique Protocol Identification Number
NCT04687410
Brief Title
Novel Crown-cut Biopsy Needle (FNB) vs Standard Aspiration Needle (FNA) for EUS-guided Diagnosis of SPLs
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2020 (Actual)
Primary Completion Date
April 1, 2021 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Neoplasm, Pancreas Cancer
Keywords
fine needle aspiration, fine needle biopsy, solid pancreatic lesion, pancreatic neoplasm, pancreatic cancer, endoscopic ultrasound, EUS-FNA, EUS-FNB

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FNA
Arm Type
Active Comparator
Arm Title
FNB
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
ProControl, MediGlobe
Intervention Description
standard 22G FNA needle
Intervention Type
Device
Intervention Name(s)
TopGain, Medi-Globe
Intervention Description
novel 22G crown-cut FNB needle
Primary Outcome Measure Information:
Title
Amount of tissue micro-fragments
Description
Comparison of median number of tissue micro-fragments
Time Frame
1 month
Title
Diagnostic tissue area
Description
Comparison of total diagnostic tissue area in um2
Time Frame
1 month
Title
Total tissue area
Description
Comparison of total total tissue area in um2
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Diagnostic yield
Description
diagnostic yield - defined by percentage of diagnostic samples in each group
Time Frame
1 month
Title
Diagnostic performance
Description
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
Time Frame
12 month
Title
Adverse event rate
Description
Comparison of proportions of patients experiencing AE in each group as defined by ASGE's lexicon on adverse events in endoscopy
Time Frame
1 month
Title
Mean DNA concentration
Time Frame
6 months
Title
Suitability for molecular analyses
Description
Percentage of samples where NGS analysis was successful
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bojan Kovacevic
Phone
+4538686312
Email
bojan.kovacevic@regionh.dk
Facility Information:
Facility Name
Gastro Unit, Division of Endoscopy
City
Herlev
State/Province
Danmark
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bojan Kovacevic, MD
Phone
+4538686312
Email
bojan.kovacevic@regionh.dk

12. IPD Sharing Statement

Learn more about this trial

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

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