Clinical trialNAUnknown
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
- Outcome
- Outcome unknown
- Phase
- NA
- Status
- Unknown
- Study type
- Interventional
- Start
- 1 March 2019
- Expected end
- 1 August 2020
- Enrollment
- 1,224 participants
- Sites
- 1
- Primary outcomes
- The diagnostic yields
- Sponsor
- Other
- Results posted
- No
- Last update
- 17 January 2019
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Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
This is a single-blind, randomized, controlled trial. One thousand two hundred and twenty four patients with solid pancreatic lesions referred for EUS guided fine needle biopsy will be randomly assigned to 4 arms. For arm A1 which will be used with 22G EUS Procore fine needle biopsy device, the pass sequence is slow pull(SP)-modified wet suction technique(MWST)-slow pull(SP)-modified wet suction technique(MWST). For arm A2 with 22G EUS Procore fine needle biopsy device, the pass sequence is MWST-SP-MWST-SP. For arm B1 with 20G EUS Procore fine needle biopsy device, the pass sequence is SP-MWST-SP-MWST. For arm B2 with 20G EUS Procore fine needle biopsy device, the pass sequence is MWST-SP-MWST-SP. All procedures will be performed by experienced echoendoscopists, and the patients and assessors (cytologists and pathologists) will be blinded during the entire study. The primary outcome measure is the diagnosis yield. Secondary outcome measures are specimen quality.
Papers 7
- BackgroundAnalysis of Fine-Needle Biopsy vs Fine-Needle Aspiration in Diagnosis of Pancreatic and Abdominal Masses: A Prospective… DOI 10.1016/j.cgh.2017.07.010↗
- BackgroundClinical use of endoscopic ultrasound-guided fine-needle aspiration: Guidelines and recommendations from Chinese Societ… DOI 10.4103/eus.eus_20_17↗
- BackgroundEndoscopic ultrasound-guided fine needle aspiration: The wet suction technique. DOI 10.4103/2303-9027.175877↗
- Background"Wet suction technique (WEST)": a novel way to enhance the quality of EUS-FNA aspirate. Results of a prospective, singl… DOI 10.1016/j.gie.2014.11.023↗
- BackgroundRandomized trial comparing the 22-gauge aspiration and 22-gauge biopsy needles for EUS-guided sampling of solid pancrea… DOI 10.1016/j.gie.2012.03.1392↗
- BackgroundFalse positive endoscopic ultrasound fine needle aspiration cytology: incidence and risk factors. DOI 10.1136/gut.2009.187765↗
- BackgroundEUS-guided FNA of pancreatic metastases: a multicenter experience. DOI 10.1016/s0016-5107(05)00287-7↗