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

Sponsor

Huazhong University of Science and Technology (Other)

Overall Status

Unknown status

CT.gov ID

NCT03803930

Collaborator

(none)

1,224

Enrollment

Location

Arms

17.1

Anticipated Duration (Months)

71.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreas Neoplasms	Device: Using 22G FNB, the first pass is SP Device: Using 22G FNB, the first pass is MWST Device: Using 20G FNB, the first pass is SP Device: Using 20G FNB, the first pass is MWST	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

1224 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2019

Anticipated Primary Completion Date :

Jun 1, 2020

Anticipated Study Completion Date :

Aug 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Arm 22G+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 SP Using 22G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST.
Other: Arm 22G+MWST Using 22G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP.	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.
Other: Arm 20G+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 SP Using 20G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST.
Other: Arm 20G+MWST Using 20G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP.	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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bin Cheng	Wuhan	Hubei	China	430030

Sponsors and Collaborators

Huazhong University of Science and Technology

Investigators

Principal Investigator: Bin Cheng, Tongji Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bin Cheng, professor, Huazhong University of Science and Technology

ClinicalTrials.gov Identifier:

NCT03803930

Other Study ID Numbers:

FNB20

First Posted:

Jan 15, 2019

Last Update Posted:

Jan 17, 2019

Last Verified:

Jan 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Bin Cheng, professor, Huazhong University of Science and Technology

EUS-FNB

slow pull

modified wet suction technique

Additional relevant MeSH terms:

Pancreatic Neoplasms

Study Results

No Results Posted as of Jan 17, 2019