NCT02181140

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pancreatic Neoplasm

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-08-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2014-07-03
• Last updated: 2019-06-18
• Results posted: 2015-09-16

Locations

1 site across 1 country: Germany