Clinical trial NCT02181140: Core Biopsy Endo Sonography Study Evaluation of the Significance of the Pro-core® Needle
Official title: Prospective Evaluation of the Significance of the Pro-core® Needle in Differential Diagnosis of Tumorous and Inflammatory Processes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Neoplasm
Keywords: 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
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2014-07-03
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic Accuracy
timeFrame: up to 1 year
Secondary outcomes:
measure: EUS Pro Core FNA: Histology Samples
timeFrame: day 0 and day 14
measure: Complication Rates
timeFrame: day 0 and day 14
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
Study officials:
affiliation: University Hospital Eppendorf, Hamburg
name: Thomas Rösch, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
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