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

Primary Purpose

Lymph Node Disease

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
22G-ProCore Endobronchial Ultrasound Needle
22G-Standard Endobronchial Ultrasound Needle
Sponsored by
Jiayuan Sun
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lymph Node Disease focused on measuring ProCore, Mediastinal and Hilar Lymphadenopathy, EBUS-TBNA, Diagnostic Yield, Quality of Specimen

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Chest HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

22G-ProCore Group

22G-Standard Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Diagnostic yield of 22G-ProCore needle
Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.
Diagnostic yield of 22G-Standard needle
Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.

Secondary Outcome Measures

The quality of histologic specimen used by 22G-ProCore needle
The number and ratio of cellularity, blood contamination, and core-tissue acquisition.
The quality of histologic specimen used by 22G-Standard needle
The number and ratio of cellularity, blood contamination, and core-tissue acquisition.

Full Information

First Posted
March 31, 2019
Last Updated
September 27, 2022
Sponsor
Jiayuan Sun
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1. Study Identification

Unique Protocol Identification Number
NCT03903471
Brief Title
22G-ProCore vs 22G-Standard Needle in Diagnosis of Lymphadenopathy by EBUS-TBNA
Official Title
Comparion of 22G-ProCore and 22G-Standard Needle in Diagnosis of Lymphadenopathy Via EBUS-TBNA: A Prospective, Single-center, Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 8, 2022 (Anticipated)
Primary Completion Date
October 8, 2023 (Anticipated)
Study Completion Date
October 8, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jiayuan Sun

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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, single-center, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymph Node Disease
Keywords
ProCore, Mediastinal and Hilar Lymphadenopathy, EBUS-TBNA, Diagnostic Yield, Quality of Specimen

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
22G-ProCore Group
Arm Type
Experimental
Arm Description
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.
Arm Title
22G-Standard Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
22G-ProCore Endobronchial Ultrasound Needle
Intervention Description
EchoTip Procore® Endobronchial HD Ultrasound Biopsy Needle, COOK
Intervention Type
Device
Intervention Name(s)
22G-Standard Endobronchial Ultrasound Needle
Intervention Description
EchoTip® Ultra Endobronchial High Definition Ultrasound Needle, COOK
Primary Outcome Measure Information:
Title
Diagnostic yield of 22G-ProCore needle
Description
Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.
Time Frame
up to 6 months
Title
Diagnostic yield of 22G-Standard needle
Description
Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
The quality of histologic specimen used by 22G-ProCore needle
Description
The number and ratio of cellularity, blood contamination, and core-tissue acquisition.
Time Frame
up to 6 months
Title
The quality of histologic specimen used by 22G-Standard needle
Description
The number and ratio of cellularity, blood contamination, and core-tissue acquisition.
Time Frame
up to 6 months
Other Pre-specified Outcome Measures:
Title
Diagnostic yield of aspiration techniques
Description
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.
Time Frame
up to 6 months
Title
Diagnostic yield of different agitations
Description
Agitation means needle moving 10 or 20 or 30 times back and forth in lymph nodes per pass.
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Accessible mediastinal and hilar lymphadenopathy to EBUS-TBNA. Inform consent signed. Exclusion Criteria: Contraindications of EBUS-TBNA. Such as use of anticoagulant therapy or presence of a coagulopathy (platelet count < 50000 or INR > 1.5). Severe cardiopulmonary dysfunction and other indications that can't tolerate bronchoscopy. Life expectancy less than 6 months. Uncooperative patients. Patients representing vulnerable populations (prisoners, pregnant women, etc). Researchers consider it inappropriate to participate in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiayuan Sun, PhD
Phone
+86-021-22200000
Ext
1511
Email
jysun1976@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiayuan Sun, MD,PhD
Organizational Affiliation
Shanghai Chest Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Chest Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiayuan Sun, PhD
Phone
+86-021-22200000
Ext
1511
Email
jysun1976@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25976686
Citation
Stamatis G. Staging of lung cancer: the role of noninvasive, minimally invasive and invasive techniques. Eur Respir J. 2015 Aug;46(2):521-31. doi: 10.1183/09031936.00126714. Epub 2015 May 14.
Results Reference
background
PubMed Identifier
27755785
Citation
Sun J, Zhang J, Zhao H, Shen J, Gu A, Han B. Role of endobronchial ultrasound-guided transbronchial needle aspiration in the diagnosis of bronchogenic carcinoma: Experience of a single institution in China. Thorac Cancer. 2010 May;1(1):28-34. doi: 10.1111/j.1759-7714.2010.00010.x.
Results Reference
background
PubMed Identifier
24035300
Citation
Sun J, Teng J, Yang H, Li Z, Zhang J, Zhao H, Garfield DH, Han B. Endobronchial ultrasound-guided transbronchial needle aspiration in diagnosing intrathoracic tuberculosis. Ann Thorac Surg. 2013 Dec;96(6):2021-7. doi: 10.1016/j.athoracsur.2013.07.005. Epub 2013 Sep 12.
Results Reference
background
PubMed Identifier
25497069
Citation
Sun J, Yang H, Teng J, Zhang J, Zhao H, Garfield DH, Han B. Determining factors in diagnosing pulmonary sarcoidosis by endobronchial ultrasound-guided transbronchial needle aspiration. Ann Thorac Surg. 2015 Feb;99(2):441-5. doi: 10.1016/j.athoracsur.2014.09.029. Epub 2014 Dec 12. Erratum In: Ann Thorac Surg. 2015 Jun;99(6):2257.
Results Reference
background
PubMed Identifier
27882677
Citation
Yang H, Wang S, Teng J, Han B, Sun J. Utility of endobronchial ultrasound-guided transbronchial needle aspiration in diagnosing non-specific inflammatory intrathorcacic lymphadenitis. Clin Respir J. 2018 Feb;12(2):691-698. doi: 10.1111/crj.12580. Epub 2016 Nov 23.
Results Reference
background

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

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