Core Biopsy Endo Sonography Study Evaluation of the Significance of the Pro-core® Needle (COS)
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|ClinicalTrials.gov Identifier: NCT02181140|
Recruitment Status : Completed
First Posted : July 3, 2014
Results First Posted : September 16, 2015
Last Update Posted : June 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Neoplasm||Device: EUS guided FNA and fine needle punction||Not Applicable|
Endoscopic ultrasound is an established examination method for tumors of the gastrointestinal tract and the pancreas. Since imaging by itself is limited in differential diagnosis of tumors, EUS guided fine needle aspiration is seen as a valid complementary method. Since fine-needle aspiration (FNA) is mainly based on cytological diagnostics, this method is limited also because of lacking supplementary immune- histochemical diagnostics. Here, the obtainment of little histologically evaluable tissue samples (punched barrels) would be of benefit.
A new punch needle device called Pro-core needle (Cook)(22 / 19 gauges) offers the possibility of increasing numbers of valid extractions of histologically evaluable tissues due to a better targeted precision and maneuverability in comparison to other devices of that kind (tru-cut needles, e.g.). A little notch at the pinpoint allows the obtainment of little tissue samples, that will be kept within the device by aspiration.
This study compares the obtainment of tissue by Proc-core needle and conventional aspiration punction systems.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Evaluation of the Significance of the Pro-core® Needle in Differential Diagnosis of Tumorous and Inflammatory Processes|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
EUS guided FNA and fine needle punction
punction of endosonographically identified space-occupying process with aspirating fine needle and pro core fine needle in a randomized order
Device: EUS guided FNA and fine needle punction
punction of a suspect area by a EUS guided fine needle as well as pro core fine needle to evacuate histology and smear biologics
- Diagnostic Accuracy [ Time Frame: up to 1 year ]
Diagnostic accuracy of Pro-core needle (22 G) will be compared to conventional fine needle aspiration (22 G). Therefore EUS-FNA with both needles is undertaken in a random order in each lesion. For Pro-core needle, a histological / cytological diagnosis and quality assessment will be made by pathologists.For Echotip aspiration needle, reference cytology evaluation is done by cytology experts.
The histopathological diagnosis after surgery or the clinical follow up of at least one year after EUS FNA is current standard.
- EUS Pro Core FNA: Histology Samples [ Time Frame: day 0 and day 14 ]Histology (not cytology) samples for Pro-core Needle: Number of adequately evaluable histology samples
- Complication Rates [ Time Frame: day 0 and day 14 ]Complication rates of EUS FNA
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): NCT02181140
|Hamburg, Germany, 20246|
|Principal Investigator:||Thomas Rösch, Prof. Dr.||University Hospital Eppendorf, Hamburg|