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22G-ProCore vs 22G-Standard Needle in Diagnosis of Lymphadenopathy by EBUS-TBNA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03903471
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : April 4, 2019
Sponsor:
Collaborators:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Beijing Cancer Hospital
Information provided by (Responsible Party):
Jiayuan Sun, Shanghai Chest Hospital

Brief Summary:
The aim of this study is to compare the performance of 22G-ProCore and 22G-Standard needle in diagnosis of mediastinal and hilar lymphadenopathy via EBUS-TBNA with the purpose to explore the optimal technique for obtaining diagnostic material.

Condition or disease Intervention/treatment Phase
Lymph Node Disease Device: 22G-ProCore Endobronchial Ultrasound Needle Device: 22G-Standard Endobronchial Ultrasound Needle Not Applicable

Detailed Description:
EBUS-TBNA is an important minimally invasive tool for the diagnosis of mediastinal and hilar lymphadenopathy. The investigators will explore the performance of two kinds of needles and different methods to obtain tissues via EBUS-TBNA in the study. The study is designed as a prospective, multicenter, randomized controlled trial, 600 patients will be expected to enroll in the study and randomly assigned to two groups, the 22G-ProCore group and the 22G-Standard group. The primary aim is to compare the diagnostic yields of the two types of needles. The secondary endpoint is to assess the quality of histologic specimen. Meanwhile, stylet slow-pull or negative suction techniques and different agitations (10, 20, 30 times) that each pass includes will be evaluated in the study as well.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparion of 22G-ProCore and 22G-Standard Needle in Diagnosis of Lymphadenopathy Via EBUS-TBNA: A Prospective, Multicenter, Randomized Controlled Clinical Trial
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 30, 2020

Arm Intervention/treatment
Experimental: 22G-ProCore Group
The experimental group with 22G-ProCore needle is expected to enroll 300 patients. The 22G-ProCore needle has a 1.5mm long groove 2.5mm above the needle tip, which is expected to have the advantage of taking more biopsy tissues than the 22G-Standard needle.
Device: 22G-ProCore Endobronchial Ultrasound Needle
EchoTip Procore® Endobronchial HD Ultrasound Biopsy Needle, COOK

Active Comparator: 22G-Standard Group
The control group of 22G-Standard needle is expected to include 300 patients, and there is no groove above the needle tip compared with 22G-ProCore needle.
Device: 22G-Standard Endobronchial Ultrasound Needle
EchoTip® Ultra Endobronchial High Definition Ultrasound Needle, COOK




Primary Outcome Measures :
  1. Diagnostic yield of 22G-ProCore needle [ Time Frame: up to 6 months ]
    Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.

  2. Diagnostic yield of 22G-Standard needle [ Time Frame: up to 6 months ]
    Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.


Secondary Outcome Measures :
  1. The quality of histologic specimen used by 22G-ProCore needle [ Time Frame: up to 6 months ]
    The number and ratio of cellularity, blood contamination, and core-tissue acquisition.

  2. The quality of histologic specimen used by 22G-Standard needle [ Time Frame: up to 6 months ]
    The number and ratio of cellularity, blood contamination, and core-tissue acquisition.


Other Outcome Measures:
  1. Diagnostic yield of aspiration techniques [ Time Frame: up to 6 months ]
    Conventional EBUS-TBNA procedures involve use of 10mL negative suction aspiration techniques. A new aspiration method, the stylet slow-pull technique, involves slow withdrawal of the needle stylet to create minimum negative pressure.

  2. Diagnostic yield of different agitations [ Time Frame: up to 6 months ]
    Agitation means needle moving 10 or 20 or 30 times back and forth in lymph nodes per pass.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Imaging examination indicates enlarged intrathoracic lymph nodes need pathological diagnosis (any lymph node has a short diameter > 1 cm in CT or PET-CT SUV value > 2.5).
  2. Accessible mediastinal and hilar lymphadenopathy to EBUS-TBNA.
  3. Inform consent signed.

Exclusion Criteria:

  1. Contraindications of EBUS-TBNA. Such as use of anticoagulant therapy or presence of a coagulopathy (platelet count < 50000 or INR > 1.5).
  2. Severe cardiopulmonary dysfunction and other indications that can't tolerate bronchoscopy.
  3. Life expectancy less than 6 months.
  4. Uncooperative patients.
  5. Patients representing vulnerable populations (prisoners, pregnant women, etc).
  6. Researchers consider it inappropriate to participate in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03903471


Contacts
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Contact: Jiayuan Sun, PhD +86-021-22200000 ext 1511 jysun1976@163.com

Locations
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China, Shanghai
Shanghai Chest Hospital Recruiting
Shanghai, Shanghai, China, 200030
Contact: Jiayuan Sun, PhD    +86-021-22200000 ext 1511    jysun1976@163.com   
Sponsors and Collaborators
Jiayuan Sun
Second Affiliated Hospital, School of Medicine, Zhejiang University
Beijing Cancer Hospital
Investigators
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Principal Investigator: Qi Wu Beijing Cancer Hospital
Principal Investigator: Hao Xu Second Affiliated Hospital, School of Medicine, Zhejiang University
Publications:
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Responsible Party: Jiayuan Sun, Director, Department of Respiratory Endoscopy and Interventional Pulmonology, Shanghai Chest Hospital, Shanghai Chest Hospital
ClinicalTrials.gov Identifier: NCT03903471    
Other Study ID Numbers: SHCHE201901
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiayuan Sun, Shanghai Chest Hospital:
ProCore
Mediastinal and Hilar Lymphadenopathy
EBUS-TBNA
Diagnostic Yield
Quality of Specimen
Additional relevant MeSH terms:
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Lymphadenopathy
Lymphatic Diseases