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

Universitätsklinikum Hamburg-Eppendorf

Status: Completed

Conditions: Pancreatic Neoplasm

Treatments: Device: EUS guided FNA and fine needle punction

Study type: Interventional

Funder types: Other

Identifiers

NCT02181140

PV 3835

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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56 participants in 1 patient group

EUS guided FNA and fine needle punction

Other group

Description:

punction of endosonographically identified space-occupying process with aspirating fine needle and pro core fine needle in a randomized order

Treatment:

Device: EUS guided FNA and fine needle punction