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

Not Applicable

Completed

• Conditions: Pancreatic Neoplasm
• Interventions: Device: EUS guided FNA and fine needle punction

• Registration Number: NCT02181140
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2013-07-08
• Study First Submitted QC: 2014-07-02
• Study First Posted: 2014-07-03
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Results First Submitted: 2015-05-21
• Results First Submitted QC: 2015-08-15
• Results First Posted: 2015-09-16
• Status Verified: 2019-04
• Last Update Submitted: 2019-06-05
• Last Update Posted: 2019-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EUS guided FNA and fine needle punction	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

Primary Outcome Measures

Name	Time	Method
Diagnostic Accuracy	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany