Pancreatic Core Biopsy Needle Study in Patients Suspected of Pancreatic Malignancy

Study Overview
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Brief Summary
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This study evaluates whether a new endoscopic ultrasonography (EUS) histology needle may improve the diagnostic yield during biopsies of pancreatic lesions

Detailed Description
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Pancreatic cancer has a poor prognosis, and a quick and correct diagnosis is essential. Endoscopic ultrasonography (EUS) is highly accurate regarding the detection of pancreatic cancer, and EUS guided fine-needle aspiration biopsy (EUS-FNA) may be used to verify the diagnosis in patients with non-resectable or metastatic disease. However, EUS-FNA is only diagnostic in approximately 70% of the cases, and the reported number of atypical, suspicious and insufficient biopsies varies. SharkCore (TM) is a new type of EUS fine needle that allows the extraction of macroscopic tissue fractions (trucut biopsies) instead of single cells or cluster of cells. Preliminary data suggest that EUS guided trucut biopsies from the pancreatic lesions are technically feasible without increasing the number of complications. This prospective study evaluates the clinical outcome and potential complications following EUS guided biopsy of pancreatic lesions suspected of cancer using a 25 Gauge or 22 Gauge SharkCore needle.

Official Title
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Pancreatic Core Biopsy Needle Study (PANCOBE)

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Device: SharkCore (TM) FNB Exchange System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pancreatic lesion suspected of malignancy and EUS biopsy indicated Exclusion Criteria: Resectable pancreatic lesions

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EUS biopsy<br>EUS guided SharkCore (TM) biopsy of pancreatic lesions suspected of malignancy | Device: SharkCore (TM) FNB Exchange System<br> <br> * Other names: 25 Gauge or 22 Gauge SharkCore needle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of conclusive biopsies |  | minimum 6 moths after biopsy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | All contacts to the secondary health care system | 2 weeks after biopsy | 
| Quality test of biopsies | Biopsies divided into: 1) diagnostic 2a) if not diagnostic - representative material 2b) if not diagnostic - not representative material 3) Insufficient material | 2 weeks after biopsy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endoscopic ultrasonography, EUS-FNA