Clinical trial · Interventional
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
NCT02181140CI-TRIAL-00039104COScompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Neoplasm | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EUS guided FNA and fine needle punction | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- EUS guided FNA and fine needle punction
- description
- punction of endosonographically identified space-occupying process with aspirating fine needle and pro core fine needle in a randomized order
- interventionNames
- Device: EUS guided FNA and fine needle punction
Primary outcomes (1)
- measure
- Diagnostic Accuracy
- timeFrame
- up to 1 year
- description
- 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 (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (23)
- BACKGROUNDParikh P, Shiloach M, Cohen ME, Bilimoria KY, Ko CY, Hall BL, Pitt HA. Pancreatectomy risk calculator: an ACS-NSQIP resource. HPB (Oxford). 2010 Sep;12(7):488-97. doi: 10.1111/j.1477-2574.2010.00216.x. PMID 20815858
- BACKGROUNDvan der Gaag NA, Rauws EA, van Eijck CH, Bruno MJ, van der Harst E, Kubben FJ, Gerritsen JJ, Greve JW, Gerhards MF, de Hingh IH, Klinkenbijl JH, Nio CY, de Castro SM, Busch OR, van Gulik TM, Bossuyt PM, Gouma DJ. Preoperative biliary drainage for cancer of the head of the pancreas. N Engl J Med. 2010 Jan 14;362(2):129-37. doi: 10.1056/NEJMoa0903230. PMID 20071702
- BACKGROUNDMoller K, Papanikolaou IS, Toermer T, Delicha EM, Sarbia M, Schenck U, Koch M, Al-Abadi H, Meining A, Schmidt H, Schulz HJ, Wiedenmann B, Rosch T. EUS-guided FNA of solid pancreatic masses: high yield of 2 passes with combined histologic-cytologic analysis. Gastrointest Endosc. 2009 Jul;70(1):60-9. doi: 10.1016/j.gie.2008.10.008. Epub 2009 Apr 25. PMID 19394012
- BACKGROUNDTakahashi K, Yamao K, Okubo K, Sawaki A, Mizuno N, Ashida R, Koshikawa T, Ueyama Y, Kasugai K, Hase S, Kakumu S. Differential diagnosis of pancreatic cancer and focal pancreatitis by using EUS-guided FNA. Gastrointest Endosc. 2005 Jan;61(1):76-9. doi: 10.1016/s0016-5107(04)02224-2. PMID 15672060
- BACKGROUNDIglesias-Garcia J, Dominguez-Munoz E, Lozano-Leon A, Abdulkader I, Larino-Noia J, Antunez J, Forteza J. Impact of endoscopic ultrasound-guided fine needle biopsy for diagnosis of pancreatic masses. World J Gastroenterol. 2007 Jan 14;13(2):289-93. doi: 10.3748/wjg.v13.i2.289. PMID 17226911
- BACKGROUNDSudhoff T, Hollerbach S, Wilhelms I, Willert J, Reiser M, Topalidis T, Schmiegel W, Graeven U. [Clinical utility of EUS-FNA in upper gastrointestinal and mediastinal disease]. Dtsch Med Wochenschr. 2004 Oct 15;129(42):2227-32. doi: 10.1055/s-2004-831867. German. PMID 15483756