Prospective Evaluation of the Significance of the Pro-core® Needle in Differential Diagnosis of Tumorous and Inflammatory Processes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pancreatic Neoplasm
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Diagnostic Accuracy
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Prof. Dr. Thomas Rösch
Medical Director, Interdisciplinary Endoscopy Department and Clinic
Universitätsklinikum Hamburg-Eppendorf
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
Outcomes
Primary Outcomes
Diagnostic Accuracy
Time Frame: 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 Outcomes
- Complication Rates(day 0 and day 14)
- EUS Pro Core FNA: Histology Samples(day 0 and day 14)