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Uniportal Tubeless VATS for the Evaluation of Biopsy for Second-generation Sequencing in Patients With Advanced NSCLC

J

Jianxing He

Status

Not yet enrolling

Conditions

CT Guided Puncture Biopsy
Biopsy Technique
NGS
NSCLC
VATS

Treatments

Diagnostic Test: CT-guided fine needle biopsy
Diagnostic Test: vats

Study type

Interventional

Funder types

Other

Identifiers

NCT04950907
20210301

Details and patient eligibility

About

The study is a single-center, prospective, open-label randomized controlled study. This study evaluates the eligibility rate of different biopsy methods (tubeless tubeless VATS vs. CT guided fine needle aspiration) for the detection of molecular genetic characteristics of peripheral NSCLC next-generation sequencing, and its main purpose is to evaluate the use of tumor gene profiling (NGS) The best biopsy technique, the First Affiliated Hospital of Guangzhou Medical University is the research center. It is expected to be completed between 2021-3-1 and 2023-3-1.

Enrollment

94 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Informed consent is obtained
  • Assessed by more than 2 surgeons, patients whose lesions can be achieved by tubeless single-port thoracoscopic surgical biopsy

Exclusion criteria

  • History of other malignant tumors.
  • The general condition is not suitable for puncture, bronchoscopy, or surgery (such as cardiopulmonary dysfunction, high risk of bleeding, allergy to anesthetics, confusion, inability to exercise, etc.)
  • History of lung surgery, tuberculosis and coal mine work experience, etc. may cause severe chest adhesions; other situations that conflict with the biopsy process

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

94 participants in 2 patient groups

treatment
Experimental group
Description:
Uniportal VATS biopsy
Treatment:
Diagnostic Test: vats
control
Active Comparator group
Description:
CT-guided fine needle biopsy
Treatment:
Diagnostic Test: CT-guided fine needle biopsy

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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