Clinical trialNACompleted
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
- Outcome
- Outcome unknown
- Phase
- NA
- Status
- Completed
- Study type
- Interventional
- Start
- August 2011
- Expected end
- October 2014
- Enrollment
- 56 participants
- Sites
- 1
- Primary outcomes
- Diagnostic Accuracy
- Sponsor
- Other
- Results posted
- 2015-09-16
- Last update
- 18 June 2019
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Diagnostic Accuracy [up to 1 year]. Number, Diagnostic accuracy (%). EUS Guided Pro Core FNA (n=56): 84.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
EUS Pro Core FNA: Histology Samples [day 0 and day 14]. Number, participants. EUS Guided Pro Core FNA (n=56): 36.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Complication Rates [day 0 and day 14]. Number, participants. EUS Guided FNA (n=56): 0.
Papers 2
- Registry-listed results paper22-gauge core vs 22-gauge aspiration needle for endoscopic ultrasound-guided sampling of abdominal masses. DOI 10.3748/wjg.v22.i39.8820↗
- BackgroundEndosonography-guided fine-needle aspiration biopsy: diagnostic accuracy and complication assessment. DOI 10.1016/s0016-5085(97)70164-1↗
The registry lists these as results papers; in a hand check of 27 such links about 78% reported the trial’s results, so read the paper before treating it as the outcome.