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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03016637
Recruitment Status : Completed
First Posted : January 10, 2017
Last Update Posted : January 11, 2017
Information provided by (Responsible Party):
Michael Bau Mortensen, 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

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Device: SharkCore (TM) FNB Exchange System Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pancreatic Core Biopsy Needle Study (PANCOBE)
Study Start Date : January 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: EUS biopsy
EUS guided SharkCore (TM) biopsy of pancreatic lesions suspected of malignancy
Device: SharkCore (TM) FNB Exchange System
Other Name: 25 Gauge or 22 Gauge SharkCore needle

Primary Outcome Measures :
  1. Number of conclusive biopsies [ Time Frame: minimum 6 moths after biopsy ]

Secondary Outcome Measures :
  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:

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Pancreatic lesion suspected of malignancy and EUS biopsy indicated

Exclusion Criteria:

  • Resectable pancreatic lesions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03016637

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Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
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Study Director: Michael B Mortensen, Professor Odense University Hospital, University of Southern denmark
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Responsible Party: Michael Bau Mortensen, Professor, Odense University Hospital Identifier: NCT03016637    
Other Study ID Numbers: MBM-71
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Michael Bau Mortensen, Odense University Hospital:
endoscopic ultrasonography