NCT04605042

Comparsion of WT and SNP Techniques of EUS-FNB in Pancreatic Solid Mass (WESP-PSM)

A Multicenter Prospective Clinical Study of Wet-suction Technique and Standard Negative Pressure Technique in EUS-FNB for the Diagnosis of Pancreatic Solid Mass

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 296 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the diagnosis accuracy between of wet suction (WS) technique and standard negative pressure (SNP) technique in EUS-FNB by 22G EUS Procore fine needle biopsy（FNB）device for solid pancreatic lesions.

Detailed description

This is a multi-center, single-blind, randomized, controlled trial. two hundred and ninety six patients with solid pancreatic lesions referred for EUS guided fine needle biopsy will be randomly assigned to two groups. For group A which will be used with 22G EUS Procore fine needle biopsy device, the pass sequence is WS-SNP-WS-SNP technique. For group B with 22G EUS Procore fine needle biopsy device, the pass sequence is SNP-WS-SNP-WS. All procedures will be performed by experienced echo-endoscopists, 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

• Pancreatic Neoplasms
• Diagnoses Disease

Interventions

Type	Name	Description
PROCEDURE	wet suction	Before pucturing the lesion, the stylet was removed and the needle was pre-flushed with 1-2 mL of saline using a 10-mL syringe, the endoscopist then punctured the lesion and replaced the 10-mL syringe with a 10-mL pre-vacuum syringe
PROCEDURE	standard negative pressure suction	after puncturing the lesion, the endoscopist removed the stylet and attached a 10-mL pre-vacuum syringe for aspiration.

Timeline

• Start date: 2020-12-01
• Primary completion: 2022-06-01
• Completion: 2022-09-30
• First posted: 2020-10-27
• Last updated: 2020-11-27