NCT03803930

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,224 (estimated)
• Sponsor: Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Pancreas Neoplasms

Interventions

Type	Name	Description
DEVICE	Using 22G FNB, the first pass is SP	Using 22G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST.
DEVICE	Using 22G FNB, the first pass is MWST	Using 22G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP.
DEVICE	Using 20G FNB, the first pass is SP	Using 20G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST.
DEVICE	Using 20G FNB, the first pass is MWST	Using 20G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP.technique-slow pull.

Timeline

• Start date: 2019-03-01
• Primary completion: 2020-06-01
• Completion: 2020-08-01
• First posted: 2019-01-15
• Last updated: 2019-01-17

Locations

1 site across 1 country: China