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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04687410
Other study ID # H-20006798
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 15, 2020
Est. completion date June 1, 2021

Study information

Verified date December 2020
Source Herlev Hospital
Contact Bojan Kovacevic
Phone +4538686312
Email bojan.kovacevic@regionh.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 68
Est. completion date June 1, 2021
Est. primary completion date April 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
ProControl, MediGlobe
standard 22G FNA needle
TopGain, Medi-Globe
novel 22G crown-cut FNB needle

Locations

Country Name City State
Denmark Gastro Unit, Division of Endoscopy Herlev Danmark

Sponsors (4)

Lead Sponsor Collaborator
Peter Vilmann MD, DSc, HC, FASGE Department of Gastroenterology, Ponderas Academic Hospital Bucharest, Romania, Endoscopy Unit, Odense Hospital, Denmark, Gastro Unit, Endoscopy Section, Hvidovre Hospital, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Amount of tissue micro-fragments Comparison of median number of tissue micro-fragments 1 month
Primary Diagnostic tissue area Comparison of total diagnostic tissue area in um2 1 month
Primary Total tissue area Comparison of total total tissue area in um2 1 month
Secondary Diagnostic yield diagnostic yield - defined by percentage of diagnostic samples in each group 1 month
Secondary 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 12 month
Secondary Adverse event rate Comparison of proportions of patients experiencing AE in each group as defined by ASGE's lexicon on adverse events in endoscopy 1 month
Secondary Mean DNA concentration 6 months
Secondary Suitability for molecular analyses Percentage of samples where NGS analysis was successful 6 months
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