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

NCT ID: NCT03903471

Last Updated: 2022-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-08
• Study Completion Date: 2023-10-08

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.

Conditions

Lymph Node Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

22G-ProCore Endobronchial Ultrasound Needle

Intervention Type: DEVICE

EchoTip Procore® Endobronchial HD Ultrasound Biopsy Needle, COOK

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.

Group Type: ACTIVE_COMPARATOR

22G-Standard Endobronchial Ultrasound Needle

Intervention Type: DEVICE

EchoTip® Ultra Endobronchial High Definition Ultrasound Needle, COOK

Interventions

22G-ProCore Endobronchial Ultrasound Needle

EchoTip Procore® Endobronchial HD Ultrasound Biopsy Needle, COOK

Intervention Type: DEVICE

22G-Standard Endobronchial Ultrasound Needle

EchoTip® Ultra Endobronchial High Definition Ultrasound Needle, COOK

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiayuan Sun

OTHER

Sponsor Role: lead

Responsible Party

Jiayuan Sun

Director, Department of Respiratory Endoscopy and Interventional Pulmonology, Shanghai Chest Hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jiayuan Sun, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Chest Hospital

Locations

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiayuan Sun, PhD

Role: CONTACT

jysun1976@163.com

+86-021-22200000 ext. 1511

Facility Contacts

Jiayuan Sun, PhD

Role: primary

jysun1976@163.com

+86-021-22200000 ext. 1511

References

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Reference Type: BACKGROUND

PMID: 25976686 (View on PubMed)

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

PMID: 25497069 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27882677 (View on PubMed)

Other Identifiers

SHCHE201901

Identifier Type: -

Identifier Source: org_study_id