Comparing of a 22G EUS Procore Fine Needle Biopsy Device and a 20G EUS Procore Fine Needle Biopsy Device
1 other identifier
interventional
1,224
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 25, 2018
CompletedFirst Posted
Study publicly available on registry
January 15, 2019
CompletedStudy Start
First participant enrolled
March 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedJanuary 17, 2019
January 1, 2019
1.3 years
December 25, 2018
January 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The diagnostic yields
The investigators' primary outcome measure is to compare the diagnostic yields of 22G FNB and 20G FNB to the solid pancreatic lesions.
up to 15 months
Secondary Outcomes (1)
the tissue integrity
up to 15 months
Study Arms (4)
Arm 22G+SP
OTHERUsing 22G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST.
Arm 22G+MWST
OTHERUsing 22G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP.
Arm 20G+SP
OTHERUsing 20G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST.
Arm 20G+MWST
OTHERUsing 20G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP.
Interventions
Using 22G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST.
Using 22G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP.
Using 20G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST.
Using 20G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP.technique-slow pull.
Eligibility Criteria
You may qualify if:
- Age \>18 years old,\<85 years old;
- Gender: Male or Female;
- Presence solid occupying pancreatic lesions (the diameter\>1cm);
- Must be able to receive examinations in the research center;
- Must be able to sign the informed consent.
You may not qualify if:
- Hemoglobin≤8.0 g/dl;
- Pregnant women;
- Coagulation disorders;
- Took anticoagulants such as aspirin, warfarin in the latest week;
- Acute pancreatitis in the past two weeks;
- Cardiopulmonary dysfunction;
- Cannot sign the informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bin Cheng
Wuhan, Hubei, 430030, China
Related Publications (7)
DeWitt 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: 15855973RESULTBang 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: 22658389RESULTGe 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: 28440232RESULTGleeson 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: 20427392RESULTCheng 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: 28733257RESULTAttam 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.
PMID: 25733127RESULTVilla NA, Berzosa M, Wallace MB, Raijman I. Endoscopic ultrasound-guided fine needle aspiration: The wet suction technique. Endosc Ultrasound. 2016 Jan-Feb;5(1):17-20. doi: 10.4103/2303-9027.175877.
PMID: 26879162RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bin Cheng
Tongji Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
December 25, 2018
First Posted
January 15, 2019
Study Start
March 1, 2019
Primary Completion
June 1, 2020
Study Completion
August 1, 2020
Last Updated
January 17, 2019
Record last verified: 2019-01