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The Efficacy of Shear-wave Elastography-guided Aspiration and Biopsy for Diagnosis in Lung Tumor

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ClinicalTrials.gov Identifier: NCT03881410
Recruitment Status : Not yet recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Tracking Information
First Submitted Date  ICMJE March 15, 2019
First Posted Date  ICMJE March 19, 2019
Last Update Posted Date March 19, 2019
Estimated Study Start Date  ICMJE March 2019
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2019)
The diagnostic yield between two groups [ Time Frame: 6 months ]
sensitivity, specificity, positive predictive value, and negative predictive value
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2019)
  • Total times of the biopsy [ Time Frame: 1 day ]
    Total times of the biopsy
  • Procedure duration [ Time Frame: 1 day ]
    Time duration
  • Complication rate [ Time Frame: 1 day ]
    Complications like pneumothorax or hemothorax
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy of Shear-wave Elastography-guided Aspiration and Biopsy for Diagnosis in Lung Tumor
Official Title  ICMJE The Efficacy of Shear-wave Elastography-guided Aspiration and Biopsy for Diagnosis in Lung Tumor: a Randomized Controlled Trial
Brief Summary

To use the shear-wave elastography to assist the transthoracic ultrasound-guided aspiration biopsy of peripheral lung tumor

  1. To identify the intra-tumor heterogeneity of elasticity
  2. To increase the diagnostic yield in ultrasound-guided transthoracic biopsy of subpleural pulmonary tumor
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Condition  ICMJE Lung Tumor
Intervention  ICMJE Procedure: different types of ultrasound technique
Shear-wave elastography-guided or Convention ultrasound-guided
Study Arms  ICMJE
  • Experimental: Shear-wave elastography-guided
    Intervention: Procedure: different types of ultrasound technique
  • Active Comparator: Convention ultrasound-guided
    Intervention: Procedure: different types of ultrasound technique
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 17, 2019)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

(1) Patients with radiographic evidence of pulmonary lesions

Exclusion criteria:

  1. Age < 20 y/o
  2. Patients who cannot hold their breath for 5 seconds
  3. Inadequate shear-wave propagation of lung tumor
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yao-Wen Kuo 0972651821 zorrokuo@ntuh.gov.tw
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03881410
Other Study ID Numbers  ICMJE 201812180RINA
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party National Taiwan University Hospital
Study Sponsor  ICMJE National Taiwan University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National Taiwan University Hospital
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP