Pancreatic Core Biopsy Needle Study in Patients Suspected of Pancreatic Malignancy (PANCOBE)

Odense University Hospital

Status and phase: Completed; Phase 2; Phase 1

Conditions: Pancreatic Cancer

Treatments: Device: SharkCore (TM) FNB Exchange System

Study type: Interventional

Funder types: Other

Identifiers

NCT03016637

MBM-71

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pancreatic lesion suspected of malignancy and EUS biopsy indicated

Exclusion criteria

• Resectable pancreatic lesions

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

EUS biopsy

Experimental group

Description:

EUS guided SharkCore (TM) biopsy of pancreatic lesions suspected of malignancy

Treatment:

Device: SharkCore (TM) FNB Exchange System