Pancreatic Core Biopsy Needle Study in Patients Suspected of Pancreatic Malignancy (PANCOBE)
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|ClinicalTrials.gov Identifier: NCT03016637|
Recruitment Status : Completed
First Posted : January 10, 2017
Last Update Posted : January 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Device: SharkCore (TM) FNB Exchange System||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- Number of conclusive biopsies [ Time Frame: minimum 6 moths after biopsy ]
- Complications [ Time Frame: 2 weeks after biopsy ]All contacts to the secondary health care system
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT03016637
|Odense University Hospital|
|Odense, Denmark, 5000|
|Study Director:||Michael B Mortensen, Professor||Odense University Hospital, University of Southern denmark|