Core Biopsy Endo Sonography Study Evaluation of the Significance of the Pro-core® Needle

Study Overview
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Brief Summary
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The study is designed to evaluate the diagnostic accuracy of a new designed endoscopic ultrasonography (EUS) Core biopsy aspiration needle in comparison to a conventional EUS aspiration needle in GI-tumors.

Detailed Description
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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.

Official Title
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Prospective Evaluation of the Significance of the Pro-core® Needle in Differential Diagnosis of Tumorous and Inflammatory Processes

Conditions
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Pancreatic Neoplasm

Intervention / Treatment
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* Device: EUS guided FNA and fine needle punction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical indication for endoscopic ultrasound diagnostics with fine needle biopsies age greater than 18 years Exclusion Criteria: difficult or impossible approach to desired structures due to anatomy (postoperative anatomy, e.g.) cystic lesion, e.g. cystic pancreas tumors coagulopathy severe general condition of the patient other contraindications for endoscopical ultrasound aided fine needle punction

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: EUS guided FNA and fine needle punction<br>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<br>* punction of a suspect area by a EUS guided fine needle as well as pro core fine needle to evacuate histology and smear biologics<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Accuracy | 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. | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EUS Pro Core FNA: Histology Samples | Histology (not cytology) samples for Pro-core Needle: Number of adequately evaluable histology samples | day 0 and day 14 | 
| Complication Rates | Complication rates of EUS FNA | day 0 and day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fine needle aspiration, core biopsy, endoscopic ultrasound, space occupying process mediastinal, perigastral, perihilar, suspect lymph nodes mediastinal, perigastral or perihilar, diagnostic accuracy of EUS guided core biopsy