Clinical trial · Interventional
Prospective Multi-center, Single Blinded, Randomized, Controlled Trial of EUS-FNB and EUS-FNA on Solid Occupying Lesion
Prospective Multi-center, Single Blinded, Randomized, Controlled Trial of EUS-FNB（Endoscopic Ultrasonography-Fine Needle Biopsy ） and EUS-FNA（Endoscopic Ultrasonography-Fine Needle Aspiration ） on Solid Occupying Lesion
NCT02327065CI-TRIAL-00016474unknownN/AClinicalTrials.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 purpose of this study is to compare the diagnosis accuracy of FNA and FNB biopsy on pancreatic, retroperitoneal, mediastinum and pelvic cavity solid occupying lesions.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphatic Metastasis | — | UNRESOLVED | — |
| Neoplasm Metastases | — | UNRESOLVED | — |
| Pancreas Neoplasms | Pancreatic Neoplasm | ALIAS | 0.90 |
| Unknown Primary Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EUS-FNA (EchoTip Ultra) | Device | — | UNRESOLVED |
| EUS-FNB (EchoTip ProCore) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- EUS-FNA Group
- description
- FNA,Fine needle aspiration
- interventionNames
- Device: EUS-FNA (EchoTip Ultra)
- type
- ACTIVE_COMPARATOR
- label
- EUS-FNB Group
- description
- FNB,Fine needle biopsy
- interventionNames
- Device: EUS-FNB (EchoTip ProCore)
Primary outcomes (1)
- measure
- Diagnostic Yield on malignancy
- timeFrame
- 18 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All patients referred for EUS tissue sampling who provide informed consent Exclusion Criteria: * Coagulopathy which is not corrected
References
Publications (11)
- RESULTDeWitt J, Jowell P, Leblanc J, McHenry L, McGreevy K, Cramer H, Volmar K, Sherman S, Gress F. EUS-guided FNA of pancreatic metastases: a multicenter experience. Gastrointest Endosc. 2005 May;61(6):689-96. doi: 10.1016/s0016-5107(05)00287-7. PMID 15855973
- RESULTPuli SR, Batapati Krishna Reddy J, Bechtold ML, Ibdah JA, Antillon D, Singh S, Olyaee M, Antillon MR. Endoscopic ultrasound: it's accuracy in evaluating mediastinal lymphadenopathy? A meta-analysis and systematic review. World J Gastroenterol. 2008 May 21;14(19):3028-37. doi: 10.3748/wjg.14.3028. PMID 18494054
- RESULTPuri R, Vilmann P, Sud R, Kumar M, Taneja S, Verma K, Kaushik N. Endoscopic ultrasound-guided fine-needle aspiration cytology in the evaluation of suspected tuberculosis in patients with isolated mediastinal lymphadenopathy. Endoscopy. 2010 Jun;42(6):462-7. doi: 10.1055/s-0029-1244133. Epub 2010 Apr 29. PMID 20432206
- RESULTWiersema MJ, Vilmann P, Giovannini M, Chang KJ, Wiersema LM. Endosonography-guided fine-needle aspiration biopsy: diagnostic accuracy and complication assessment. Gastroenterology. 1997 Apr;112(4):1087-95. doi: 10.1016/s0016-5085(97)70164-1. PMID 9097990
- RESULTGress FG, Hawes RH, Savides TJ, Ikenberry SO, Lehman GA. Endoscopic ultrasound-guided fine-needle aspiration biopsy using linear array and radial scanning endosonography. Gastrointest Endosc. 1997 Mar;45(3):243-50. doi: 10.1016/s0016-5107(97)70266-9. PMID 9087830
- RESULTAffolter KE, Schmidt RL, Matynia AP, Adler DG, Factor RE. Needle size has only a limited effect on outcomes in EUS-guided fine needle aspiration: a systematic review and meta-analysis. Dig Dis Sci. 2013 Apr;58(4):1026-34. doi: 10.1007/s10620-012-2439-2. Epub 2012 Oct 21. PMID 23086117
- RESULTIglesias-Garcia J, Poley JW, Larghi A, Giovannini M, Petrone MC, Abdulkader I, Monges G, Costamagna G, Arcidiacono P, Biermann K, Rindi G, Bories E, Dogloni C, Bruno M, Dominguez-Munoz JE. Feasibility and yield of a new EUS histology needle: results from a multicenter, pooled, cohort study. Gastrointest Endosc. 2011 Jun;73(6):1189-96. doi: 10.1016/j.gie.2011.01.053. Epub 2011 Mar 21.