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Endobronchial Ultrasound Needle Aspiration With and Without Suction

NCT05110950 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 306

Last updated 2022-05-26

No results posted yet for this study

Summary

The main purpose of the present study is to compare the diagnostic yield of different aspiration techniques in Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) in the diagnosis of hilar/mediastinal adenopathy

Conditions

  • Mediastinal Lymphadenopathy
  • Hilar Lymphadenopathy
  • Lymphoma
  • Lung Neoplasms
  • Sarcoidosis
  • Tuberculosis
  • EGF-R Positive Non-Small Cell Lung Cancer
  • PDL1 Gene Mutation
  • ALK Translocation
  • ROS1 Gene Mutation

Interventions

PROCEDURE

No suction EBUS-TBNA

The needle is moved from a side to side of the lymphnode for 15 times. Each lymphnode is sampled three times. The samples obtained will be examined on-site by experienced blinded cytopathologist.All specimens obtained will be send to definitive cytological and histological evaluation and the final diagnosis will be collected and reported on CRFs.

PROCEDURE

Passive suction through dedicated EBUS-TBNA syringe

The needle is moved from a side to side of the lymphnode for 15 times. Each lymphnode is sampled three times. The samples obtained will be examined on-site by experienced blinded cytopathologist.All specimens obtained will be send to definitive cytological and histological evaluation and the final diagnosis will be collected and reported on CRFs.

PROCEDURE

Manual applied suction EBUS-TBNA through a pistol-grip syringe holder

The needle is moved from a side to side of the lymphnode for 15 times. Each lymphnode is sampled three times. The samples obtained will be examined on-site by experienced blinded cytopathologist.All specimens obtained will be send to definitive cytological and histological evaluation and the final diagnosis will be collected and reported on CRFs..

Sponsors & Collaborators

  • Università Politecnica delle Marche

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2022-06-26
Completion
2024-06-26

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05110950 on ClinicalTrials.gov