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

January 16, 2019 updated by: Bin Cheng, Huazhong University of Science and Technology

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

1224

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Bin Cheng

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The diagnostic yields
Time Frame: 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.
up to 15 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the tissue integrity
Time Frame: 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.
up to 15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huazhong University of Science and Technology

Investigators

  • Principal Investigator: Bin Cheng, Tongji Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2019

Primary Completion (ANTICIPATED)

June 1, 2020

Study Completion (ANTICIPATED)

August 1, 2020

Study Registration Dates

First Submitted

December 25, 2018

First Submitted That Met QC Criteria

January 10, 2019

First Posted (ACTUAL)

January 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 17, 2019

Last Update Submitted That Met QC Criteria

January 16, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FNB20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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