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

Peking University

Status: Unknown

Conditions: Lung Neoplasms

Treatments: Procedure: CT-TTNB; Procedure: EBUS-GS

Study type: Interventional

Funder types: Other

Identifiers

NCT02740400

CDI2014-2-4084

Details and patient eligibility

About

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.

Full description

CT-TTNB is widely used in the diagnosis of PPLs and its sensitivity for lung cancer remains as high as 90%. However, the relatively high rate of complications such as pneumothorax, hemoptysis, pulmonary hemorrhage, severe chest pain, and bad tolerance in patients limits its application.

EBUS-GS is an emerging technology, Kurimoto in 2004 performed transbronchial lung biopsy(TBLB) assisted by EBUS-GS, and the sensitivity of diagnosing lung cancer was 81%, and it was proved to be a safe procedure with very small amount of pneumothorax and hemoptysis.

Till now there is only one randomized controlled study comparing the diagnostic value of CT-TTNB and EBUS-GS; however, it did not complete the enrollment of patients on schedule. In addition, all the other studies were retrospective. Hence this prospective study was performed to determine the diagnostic value and safety of EBUS-GS and CT-TTNB for PPLs.

Enrollment: 120 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Lesions presented as nodule or mass in CT imaging and located at the distal end of the segmental bronchus; invisible under normal bronchoscope; no pathological results were obtained before biopsy procedure; patients can tolerate video assisted thoracic surgery(VATS) lobectomy or wedge resection; all patients provided written informed consent.

Exclusion criteria

• Presence of central pulmonary lesion and visible under the bronchoscope; lesions presented as exudative or consolidation in CT imaging; the location was unsuitable for CT-guided biopsy; presence of pneumothorax or pleural effusion patients have contraindication for EBUS-GS or CT-TTNB,such as cardiopulmonary dysfunction, cachexia, thrombocytopenia or coagulopathy.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

CT-TTNB

Experimental group

Description:

patients receive CT-TTNB to diagnose PPLs.

Treatment:

Procedure: CT-TTNB

EBUS-GS

Experimental group

Description:

patients receive EBUS-GS to diagnose PPLs.

Treatment:

Procedure: EBUS-GS