Clinical trial · Interventional
Comparing of a 22G EUS Procore Fine Needle Biopsy Device and a 20G EUS Procore Fine Needle Biopsy Device
Comparing of a 22G EUS Procore Fine Needle Biopsy Device and a 20G EUS Procore Fine Needle Biopsy Device for Solid Pancreatic Lesions: a Prospective Multi-center, Randomized, and Controlled Trial
NCT03803930CI-TRIAL-00036601unknownN/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 22G EUS Procore fine needle biopsy （FNB）device and 20G EUS Procore fine needle biopsy device for solid pancreatic lesions.
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 |
|---|---|---|---|
| Pancreas Neoplasms | Pancreatic Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Using 20G FNB, the first pass is MWST | Device | — | UNRESOLVED |
| Using 20G FNB, the first pass is SP | Device | — | UNRESOLVED |
| Using 22G FNB, the first pass is MWST | Device | — | UNRESOLVED |
| Using 22G FNB, the first pass is SP | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- OTHER
- label
- Arm 22G+SP
- description
- Using 22G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST.
- interventionNames
- Device: Using 22G FNB, the first pass is SP
- type
- OTHER
- label
- Arm 22G+MWST
- description
- Using 22G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP.
- interventionNames
- Device: Using 22G FNB, the first pass is MWST
- type
- OTHER
- label
- Arm 20G+SP
- description
- Using 20G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age \>18 years old,\<85 years old; 2. Gender: Male or Female; 3. Presence solid occupying pancreatic lesions (the diameter\>1cm); 4. Must be able to receive examinations in the research center; 5. Must be able to sign the informed consent. Exclusion Criteria: 1. Hemoglobin≤8.0 g/dl; 2. Pregnant women; 3. Coagulation disorders; 4. Took anticoagulants such as aspirin, warfarin in the latest week; 5. Acute pancreatitis in the past two weeks; 6. Cardiopulmonary dysfunction; 7. Cannot sign the informed consent
References
Publications (7)
- 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
- RESULTBang JY, Hebert-Magee S, Trevino J, Ramesh J, Varadarajulu S. Randomized trial comparing the 22-gauge aspiration and 22-gauge biopsy needles for EUS-guided sampling of solid pancreatic mass lesions. Gastrointest Endosc. 2012 Aug;76(2):321-7. doi: 10.1016/j.gie.2012.03.1392. Epub 2012 May 31. PMID 22658389
- RESULTGe N, Zhang S, Jin Z, Sun S, Yang A, Wang B, Wang G, Xu G, Hao J, Zhong L, Zhong N, Li P, Zhu Q, Nian W, Li W, Zhang X, Zhou X, Yang X, Cui Y, Ding Z. Clinical use of endoscopic ultrasound-guided fine-needle aspiration: Guidelines and recommendations from Chinese Society of Digestive Endoscopy. Endosc Ultrasound. 2017 Mar-Apr;6(2):75-82. doi: 10.4103/eus.eus_20_17. No abstract available. PMID 28440232
- RESULTGleeson FC, Kipp BR, Caudill JL, Clain JE, Clayton AC, Halling KC, Henry MR, Rajan E, Topazian MD, Wang KK, Wiersema MJ, Zhang J, Levy MJ. False positive endoscopic ultrasound fine needle aspiration cytology: incidence and risk factors. Gut. 2010 May;59(5):586-93. doi: 10.1136/gut.2009.187765. PMID 20427392
- RESULTCheng B, Zhang Y, Chen Q, Sun B, Deng Z, Shan H, Dou L, Wang J, Li Y, Yang X, Jiang T, Xu G, Wang G. Analysis of Fine-Needle Biopsy vs Fine-Needle Aspiration in Diagnosis of Pancreatic and Abdominal Masses: A Prospective, Multicenter, Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2018 Aug;16(8):1314-1321. doi: 10.1016/j.cgh.2017.07.010. Epub 2017 Jul 19. PMID 28733257
- RESULTAttam R, Arain MA, Bloechl SJ, Trikudanathan G, Munigala S, Bakman Y, Singh M, Wallace T, Henderson JB, Catalano MF, Guda NM. "Wet suction technique (WEST)": a novel way to enhance the quality of EUS-FNA aspirate. Results of a prospective, single-blind, randomized, controlled trial using a 22-gauge needle for EUS-FNA of solid lesions. Gastrointest Endosc. 2015;81(6):1401-7. doi: 10.1016/j.gie.2014.11.023. Epub 2015 Feb 27.