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

Shanghai Jiao Tong University

Status: Unknown

Conditions: Diagnoses Disease; Pancreatic Neoplasms

Treatments: Procedure: standard negative pressure suction; Procedure: wet suction

Study type: Interventional

Funder types: Other

Identifiers

NCT04605042

RuijinH2020301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 296 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. informed consent
2. Subjects over 18 years old
3. Imaging examination (ultrasound, CT or MRI) diagnosed or suspected solid pancreatic mass more than 1cm

Exclusion criteria

1. Unable or refused to sign informed consent
2. suspended anticoagulant/antiplatelet therapy
3. Being pregnant or breastfeeding
4. Cystic lesions of the pancreas
5. coagulation disorders (PLT <50×103/ L, INR > 1.5)
6. A history of mental illness
7. other medical conditions that are not suitable for FNB puncture

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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296 participants in 2 patient groups

WET First group

Experimental group

Description:

COOK ECHO-HD 22-C EchoTip Procore needle biopsy in WS-SNP-WS-SNP sequence

Treatment:

Procedure: standard negative pressure suction

Procedure: wet suction

STANDARD first group

Experimental group

Description:

COOK ECHO-HD 22-C EchoTip Procore needle in SNP-WS-SNP-WS sequence

Treatment:

Procedure: standard negative pressure suction

Procedure: wet suction