Pancreatic Core Biopsy Needle Study in Patients Suspected of Pancreatic Malignancy

Phase 1

Completed

• Conditions: Pancreatic Cancer
• Interventions: Device: SharkCore (TM) FNB Exchange System

• Registration Number: NCT03016637
• Lead Sponsor: Odense University Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2016-01
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-01
• Study First Submitted: 2017-01-09
• Study First Submitted QC: 2017-01-09
• Study First Posted: 2017-01-10
• Last Update Submitted: 2017-01-10
• Last Update Posted: 2017-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Pancreatic lesion suspected of malignancy and EUS biopsy indicated

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Exclusion Criteria

• Resectable pancreatic lesions

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EUS biopsy	SharkCore (TM) FNB Exchange System	EUS guided SharkCore (TM) biopsy of pancreatic lesions suspected of malignancy

Primary Outcome Measures

Name	Time	Method
Number of conclusive biopsies	minimum 6 moths after biopsy

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Denmark