Comparing of a 22G EUS Procore Fine Needle Biopsy Device and a 20G EUS Procore Fine Needle Biopsy Device

Not Applicable

• Conditions: Pancreas Neoplasms
• Interventions: Device: Using 20G FNB, the first pass is SP; Device: Using 22G FNB, the first pass is MWST; Device: Using 22G FNB, the first pass is SP; Device: Using 20G FNB, the first pass is MWST

• Registration Number: NCT03803930
• Lead Sponsor: Huazhong University of Science and Technology

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.

Study Timeline

• Study First Submitted: 2018-12-25
• Status Verified: 2019-01
• Study First Submitted QC: 2019-01-10
• Study First Posted: 2019-01-15
• Last Update Submitted: 2019-01-16
• Last Update Posted: 2019-01-17
• Study Start: 2019-03-01
• Primary Completion: 2020-06-01
• Study Completion: 2020-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1224

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 20G+SP	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.
Arm 22G+MWST	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.
Arm 22G+SP	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.
Arm 20G+MWST	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Bin Cheng; 🇨🇳 Wuhan, Hubei, China