Pancreatic Core Biopsy Needle Study in Patients Suspected of Pancreatic Malignancy

Pancreatic Core Biopsy Needle Study (PANCOBE)

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03016637

Acronym

PANCOBE

Enrollment

Registered

2017-01-10

Start date

2016-01-31

Completion date

2016-12-31

Last updated

2017-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

endoscopic ultrasonography, EUS-FNA

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.

Interventions

DEVICESharkCore (TM) FNB Exchange System

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Pancreatic lesion suspected of malignancy and EUS biopsy indicated

Exclusion criteria

* Resectable pancreatic lesions

Design outcomes

Primary

Measure	Time frame
Number of conclusive biopsies	minimum 6 moths after biopsy

Secondary

Measure	Time frame	Description
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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026