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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03803930

Enrollment

1224

Registered

2019-01-15

Start date

2019-03-01

Completion date

2020-08-01

Last updated

2019-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreas Neoplasms

Keywords

EUS-FNB, slow pull, modified wet suction technique

Brief 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.

Interventions

DEVICEUsing 22G FNB, the first pass is SP

Using 22G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST.

DEVICEUsing 22G FNB, the first pass is MWST

Using 22G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP.

DEVICEUsing 20G FNB, the first pass is SP

Using 20G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST.

DEVICEUsing 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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

1. Age \>18 years old,\<85 years old; 2. Gender: Male or Female; 3. Presence solid occupying pancreatic lesions (the diameter\>1cm); 4. Must be able to receive examinations in the research center; 5. Must be able to sign the informed consent.

Exclusion criteria

1. Hemoglobin≤8.0 g/dl; 2. Pregnant women; 3. Coagulation disorders; 4. Took anticoagulants such as aspirin, warfarin in the latest week; 5. Acute pancreatitis in the past two weeks; 6. Cardiopulmonary dysfunction; 7. Cannot sign the informed consent

Design outcomes

Primary

Measure	Time frame	Description
The diagnostic yields	up to 15 months	The investigators' primary outcome measure is to compare the diagnostic yields of 22G FNB and 20G FNB to the solid pancreatic lesions.

Secondary

Measure	Time frame	Description
the tissue integrity	up to 15 months	The investigators' secondary outcome measure is to assess the tissue size under a light microscope to compare the tissue obtained by 22G FNB and 20G FNB with Slow-pull or modified wet suction technique.

Countries

China

Contacts

Primary ContactBin Cheng

b.cheng@tjh.tjmu.edu.cn+862783663333

Backup ContactYun Wang

820308045@qq.com+862783663333

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026