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A Comparison Between EBUS-GS and CT-guided Lung Biopsy in Diagnosis of Peripheral Pulmonary Lesions.

NCT02740400 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2016-04-15

No results posted yet for this study

Summary

This is a randomized controlled trail aiming at comparing the diagnostic value and safety of endobronchial ultrasonography with a guide sheath(EBUS-GS) and computed tomography-guided transthoracic needle biopsy(CT-TTNB) for peripheral pulmonary lesions (PPLs). Patients eligible for the inclusion criteria are diagnosed using either EBUS-GS or CT-TTNB randomly. The diagnostic indicators such as sensitivity, specificity, and accuracy are compared between the two groups. Post-procedure complications are recorded.

Conditions

  • Lung Neoplasms

Interventions

PROCEDURE

EBUS-GS

The equipment for EBUS-GS includes super-thin bronchoscope BF-P260F, endobronchial ultrasonic system EU-M30S, ultrasonic probe UM-S20-17S, and guided sheath kit K201. All facilities are provided by Olympus Co. The EBUS-GS procedure was performed by thoracic surgeons. The patient was in supine position, under general anesthesia, and provided ventilatation through laryngeal mask. First, the operator placed super-thin bronchoscope into the bronchus of interest, inserted the probe covered with GS through a work channel. Later, adjusted the bronchoscope and probe to obtain classical ultrasonic graphs. The assistant fixed the bronchoscope, pulled the probe out, and placed the brush and biopsy forceps, respectively, through the GS. This process was assisted using x-ray fluoroscope or not.

PROCEDURE

CT-TTNB

The devices for CT-TTNB includes Lightspeed VCT spiral CT(GE co.) and Quickcore(COOK Co.) biopsy kit. The kit includes a sheath(5cm in length and 16G in outer diameter) and a automatic biopsy needle(15cm in length and 18G in outer diameter). The patient stays in supine, prone or lateral position according to the lesion's location. The first chest CT scan is performed to confirm the location of the lesion and make an optimal entry point. Then, after sterilization and 2% lidocaine local anesthesia, the sheath is stabbed into chest wall through the entry point. The second CT scan is performed to make sure that the sheath stays in proper angle and depth. The operator places the needle through the sheath and enter the lesion. Then fire the biopsy needle and repeat the procedure twice or third time. The last CT scan is conducted to determine whether pneumothorax or hemorrhage occurred.

Sponsors & Collaborators

  • Peking University People's Hospital

    lead OTHER

Principal Investigators

  • Guanchao Jiang, M.D. · Peking University People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-06-30
Completion
2017-05-31

Countries

  • China

Study Locations

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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 NCT02740400 on ClinicalTrials.gov