Clinical trial · Interventional
Comparison of Two Needles (19G Flex Versus 22G Standard) for Pancreatic Solid Tumors Diagnosis
Randomized, Comparative Study of 19G Flex Versus 22G Standard Needles for Pancreatic Solid Tumors Diagnosis.
NCT02078232CI-TRIAL-00027100EASYFLEXcompletedN/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 diagnostic gain between 22G standard needle vs 19G Flex needles transduodenal punctures of masses of the pancreatic head.
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 |
|---|---|---|---|
| Adenocarcinoma of Head of Pancreas | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| puncture of head of pancreas | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 19G flex needle puncture
- description
- puncture of head of pancreas
- interventionNames
- Device: puncture of head of pancreas
- type
- ACTIVE_COMPARATOR
- label
- 22G needle puncture
- description
- puncture of head of pancreas
- interventionNames
- Device: puncture of head of pancreas
Primary outcomes (1)
- measure
- accuracy of 19G Flex Expect needle in the histological diagnosis of pancreatic solid tumors of the head of pancreas
- timeFrame
- 10 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * patient with solid tumor of pancreas who has to receive a biopsy under endoscopic ultrasound (EUS) * patient who understands the study procedures, risks and voluntarily agrees to participate by giving written informed consent Exclusion Criteria: * patient who participates in an other study * patient mentally or legally incapacitated * patient with contraindications to the achievement of upper gastrointestinal endoscopy * patient with haemorrhagic disease, disorder of hemostasis and coagulation (TP\<60%, TCA\>40sec and platelets \<60000/mm3) * patient with anticoagulant or antiaggregating treatment that could not be stopped for the endoscopic procedure * patient with pancreatic cystic mass (fluid quota valued at more than 50% of the mass lesion on imaging) * patient pregnant or lactating women
References
Publications (12)
- BACKGROUNDJenssen C, Dietrich CF. Endoscopic ultrasound-guided fine-needle aspiration biopsy and trucut biopsy in gastroenterology - An overview. Best Pract Res Clin Gastroenterol. 2009;23(5):743-59. doi: 10.1016/j.bpg.2009.05.006. PMID 19744637
- BACKGROUNDTakemoto T, Aibe T, Fuji T, Okita K. Endoscopic ultrasonography. Clin Gastroenterol. 1986 Apr;15(2):305-19. PMID 3524913
- BACKGROUNDErickson RA. EUS-guided FNA. Gastrointest Endosc. 2004 Aug;60(2):267-79. doi: 10.1016/s0016-5107(04)01529-9. No abstract available. PMID 15278063
- BACKGROUNDHewitt MJ, McPhail MJ, Possamai L, Dhar A, Vlavianos P, Monahan KJ. EUS-guided FNA for diagnosis of solid pancreatic neoplasms: a meta-analysis. Gastrointest Endosc. 2012 Feb;75(2):319-31. doi: 10.1016/j.gie.2011.08.049. PMID 22248600
- BACKGROUNDSong TJ, Kim JH, Lee SS, Eum JB, Moon SH, Park DY, Seo DW, Lee SK, Jang SJ, Yun SC, Kim MH. The prospective randomized, controlled trial of endoscopic ultrasound-guided fine-needle aspiration using 22G and 19G aspiration needles for solid pancreatic or peripancreatic masses. Am J Gastroenterol. 2010 Aug;105(8):1739-45. doi: 10.1038/ajg.2010.108. Epub 2010 Mar 9. PMID 20216532
- BACKGROUNDStandards of Practice Committee of the American Society for Gastrointestinal Endoscopy; Lichtenstein DR, Jagannath S, Baron TH, Anderson MA, Banerjee S, Dominitz JA, Fanelli RD, Gan SI, Harrison ME, Ikenberry SO, Shen B, Stewart L, Khan K, Vargo JJ. Sedation and anesthesia in GI endoscopy. Gastrointest Endosc. 2008 Nov;68(5):815-26. doi: 10.1016/j.gie.2008.09.029. No abstract available. PMID 18984096
- BACKGROUNDAdler DG, Jacobson BC, Davila RE, Hirota WK, Leighton JA, Qureshi WA, Rajan E, Zuckerman MJ, Fanelli RD, Baron TH, Faigel DO; ASGE. ASGE guideline: complications of EUS. Gastrointest Endosc. 2005 Jan;61(1):8-12. doi: 10.1016/s0016-5107(04)02393-4.