Pancreatic Cancer Research

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.