EBUS-GS-TBLB With or Without Fluoroscopy for the Diagnosis of PPLs

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of endobronchial ultrasound-guide sheath(EBUS-GS) for the diagnosis of peripheral pulmonary lesions (PPLs) without radiographic fluoroscopy.

Detailed Description
-----------------
The investigators evaluated the efficacy and safety of transbronchial biopsy (TBB) and bronchial brushing by endobronchial ultrasonography (EBUS) with a guide sheath (GS) as a guide for diagnosing peripheral pulmonary lesions (PPLs) without radiographic fluoroscopy.The study is designed as a two-center prospective randomized controlled trial. The participating centers are Department of pulmonary medicine and endoscope center, Shanghai chest Hospital affiliated to Shanghai JiaoTong University School, China. Department of pulmonary medicine, Fukushima Medical University, Japan.Patients are divided into two groups, EBUS-GS-X-ray group and EBUS-GS group.Each subject will be randomized to each group.The study is expected to enroll 100 patients at 2 centers (China:75, Fukushima:25).

Official Title
-----------------
Diagnostic Value of Endobronchial Ultrasound(EBUS) With a Guide Sheath(GS) for Peripheral Pulmonary Lesions(PPLs) Without Fluoroscopy: a Randomized Controlled Trial

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Procedure: EBUS-GS
* Procedure: X-ray


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Individuals eligible for inclusion are patients that the CT scan appearance of the PPLs showed the longest diameter was more than 2 cm and solid lesions. Exclusion Criteria: The lesion is close to the pleural membrane Refusal of participation Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EBUS-GS group<br>The EBUS probe and GS are confirmed to reach the lesion by EBUS images alone, cytologic and pathologic specimens are obtained without fluoroscopic guidance. | Procedure: EBUS-GS<br>* EBUS is performed using an endoscope ultrasound system , which is equipped with a 20-MHz mechanical radial-type probe (UM-S20-17S;Olympus) with an external diameter of 1.4 mm and a GS (K-201; Olympus).<br>|
| Active Comparator: EBUS-GS-X-ray group<br>The EBUS probe and GS are confirmed to reach the lesion by EBUS images and radiograph fluoroscopy, cytologic and pathologic specimens are obtained under fluoroscopic guidance. | Procedure: EBUS-GS<br>* EBUS is performed using an endoscope ultrasound system , which is equipped with a 20-MHz mechanical radial-type probe (UM-S20-17S;Olympus) with an external diameter of 1.4 mm and a GS (K-201; Olympus).<br>Procedure: X-ray<br>* The radiograph fluoroscopy are performed when the probe and GS are confirmed to reach the lesion by EBUS images ,cytologic and pathologic specimens are obtained under fluoroscopic guidance.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference of diagnostic value of EBUS-GS-TBLB with fluoroscopy as compared to EBUS-GS-TBLB alone | The diagnostic value mean sensitivity and specificity in two groups | Up to half year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference of complications of EBUS-GS-TBLB with fluoroscopy as compared to EBUS-GS-TBLB alone | Complications mean a composite of operation-related serious adverse events (pneumothorax, bleeding, etc.) during and after the operation in two groups | Up to half year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transbronchial biopsy, Endobronchial ultrasonography with a guide sheath, Peripheral pulmonary lesions