Clinical trial · Interventional
EUS-guided Fine Needle Biopsy With a New Core Histology Needle Versus Conventional Fine Needle Aspiration
Endoscopic Ultrasound Guided Fine Needle Biopsy With a New Core Histology Needle Versus Conventional Fine Needle Aspiration.
- 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)
Endoscopic ultrasound (EUS) is a well-established tool for the diagnosis and staging of many gastrointestinal conditions, including but not limited to, malignant and pre-malignant neoplasms of the pancreas, esophagus, rectum, and submucosal tumors developing along the gastrointestinal tract. EUS is the most sensitive test for the detection of focal lesions within the pancreas and is the most accurate method for diagnosing pancreas cancer. A biopsy method for tissue sampling via EUS called fine needle aspiration (FNA) was developed that enables a small needle to be passed into the lesion of interest under ultrasound guidance, obtaining cellular material for cytology. EUS-FNA is currently recommended for the diagnosis of cystic and solid mass lesions within and adjacent to the gastrointestinal tract. Yet in certain clinical circumstances, it is more desirable and sometimes necessary to obtain a core tissue biopsy for histology rather than the cellular material for cytology obtained with EUS-FNA. Furthermore, histology may generally increase the diagnostic yield of EUS-FNA compared to cytology. It is with these aims in mind that a new type of needle, the fine needle biopsy (EUS-FNB) device was developed to enable core tissue sampling. Since a comparison of these to methods has yet to be made, the aim of this study is to perform a direct comparison of the sampling adequacy and diagnostic yield of the new EUS-FNB needle with the conventional EUS-FNA needle.
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 |
|---|---|---|---|
| Gastrointestinal Stromal Tumor | Gastrointestinal Stromal Tumor | ONTOLOGY_EXACT | 0.98 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Pancreas Adenocarcinoma | Pancreatic Adenocarcinoma | ALIAS | 0.90 |
| Pancreas Neoplasms | Pancreatic Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fine needle aspiration using conventional FNA for cytology | Device | — | UNRESOLVED |
| Fine needle biopsy using ProCore needle for histology. | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- FNA for cytology
- description
- Fine needle aspiration using conventional FNA for cytology
- interventionNames
- Device: Fine needle aspiration using conventional FNA for cytology
- type
- EXPERIMENTAL
- label
- FNB core biopsy for histology
- description
- Fine needle biopsy using ProCore needle for histology.
- interventionNames
- Device: Fine needle biopsy using ProCore needle for histology.
Primary outcomes (1)
- measure
- Sampling Adequacy
- timeFrame
- at time of procedure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patient 18 years or older * Able to read and write English * Undergoing EUS for the evaluation of: i) pancreas mass ii) intra-abdominal mass iii) suspected submucosal tumor iv) esophageal cancer staging v) other lymph node assessment Exclusion Criteria: * No detectable lesion * lesion inaccessible to EUS guided biopsy * Lesion determined to not require tissue sampling * Pancreas lesion is predominantly cystic * coagulopathy with a known clotting factor deficiency or an uncorrectable INR \> 1.5, PTT \> 40, platelet count \< 50,000
References
Publications (31)
- BACKGROUNDSaftoiu A, Vilmann P. Role of endoscopic ultrasound in the diagnosis and staging of pancreatic cancer. J Clin Ultrasound. 2009 Jan;37(1):1-17. doi: 10.1002/jcu.20534. PMID 18932265
- BACKGROUNDVilmann P, Jacobsen GK, Henriksen FW, Hancke S. Endoscopic ultrasonography with guided fine needle aspiration biopsy in pancreatic disease. Gastrointest Endosc. 1992 Mar-Apr;38(2):172-3. doi: 10.1016/s0016-5107(92)70385-x. No abstract available. PMID 1568614
- BACKGROUNDMaluf-Filho F, Dotti CM, Halwan B, Queiros AF, Kupski C, Chaves DM, Nakao FS, Kumar A. An evidence-based consensus statement on the role and application of endosonography in clinical practice. Endoscopy. 2009 Nov;41(11):979-87. doi: 10.1055/s-0029-1215192. Epub 2009 Oct 28. PMID 19866396
- BACKGROUNDWiersema 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
- BACKGROUNDEloubeidi MA, Tamhane A, Varadarajulu S, Wilcox CM. Frequency of major complications after EUS-guided FNA of solid pancreatic masses: a prospective evaluation. Gastrointest Endosc. 2006 Apr;63(4):622-9. doi: 10.1016/j.gie.2005.05.024. PMID 16564863
- BACKGROUNDBarawi M, Gottlieb K, Cunha B, Portis M, Gress F. A prospective evaluation of the incidence of bacteremia associated with EUS-guided fine-needle aspiration. Gastrointest Endosc. 2001 Feb;53(2):189-92. doi: 10.1067/mge.2001.108966. PMID 11174290
- BACKGROUNDLevy MJ, Norton ID, Wiersema MJ, Schwartz DA, Clain JE, Vazquez-Sequeiros E, Wilson WR, Zinsmeister AR, Jondal ML. Prospective risk assessment of bacteremia and other infectious complications in patients undergoing EUS-guided FNA. Gastrointest Endosc. 2003 May;57(6):672-8. doi: 10.1067/mge.2003.204.