Skip to main content
OpenTrials
Completed

NCT Number: NCT03016637

Pancreatic Core Biopsy Needle Study in Patients Suspected of Pancreatic Malignancy

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Odense University Hospital

Odense, 5000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pancreatic lesion suspected of malignancy and EUS biopsy indicated

Exclusion criteria

  • Resectable pancreatic lesions

Treatment and study plan

SharkCore (TM) FNB Exchange System

Device

Other names: 25 Gauge or 22 Gauge SharkCore needle

Primary outcomes

  1. Number of conclusive biopsies

    Time frame: minimum 6 moths after biopsy

Secondary outcomes

  1. Complications

    Time frame: 2 weeks after biopsy

    All contacts to the secondary health care system

  2. Quality test of biopsies

    Time frame: 2 weeks after biopsy

    Biopsies divided into:

    • diagnostic 2a) if not diagnostic - representative material 2b) if not diagnostic - not representative material 3) Insufficient material

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study title

Pancreatic Core Biopsy Needle Study (PANCOBE)

Acronym: PANCOBE

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 10, 2017
Registry last updated
Jan 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.