ENB-GS-TBLB for the Diagnosis of PPLs

Shanghai Jiao Tong University

Status: Completed

Conditions: Lung Cancer

Treatments: Procedure: ENB; Procedure: GS-TBLB-X-ray

Study type: Interventional

Funder types: Other

Identifiers

NCT02207478

SHCHE201401

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of electromagnetic navigation bronchoscopy with a Guide Sheath(ENB-GS) for the diagnosis of peripheral pulmonary lesions (PPLs) .

Full description

The investigators evaluated the efficacy and safety of transbronchial lung biopsy (TBLB) and bronchial brushing using electromagnetic navigation bronchoscopy (ENB) with a guide sheath (GS) for the diagnosis of peripheral pulmonary lesions (PPLs) with radiographic fluoroscopy.The study is designed as a two-center prospective randomized controlled trial. The participating centers are Department of pulmonary medicine and endoscope department, Shanghai chest Hospital affiliated to Shanghai JiaoTong University, China. Department of pulmonary medicine, Shanghai ZhongShan Hospitial affiliated to Shanghai FuDan University, China.Patients are divided into two groups, ENB-GS-TBLB-X-ray group and GS-TBLB-X-ray group.Each subject will be randomized to each group.The study is expected to enroll 60 patients at 2 centers (Shanghai Chest Hospital: 40, Shanghai Zhongshan Hospital: 20).

Enrollment: 80 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. clinical and imaging characteristics suggestive of maligancy
2. CT scan appearance of the PPLs showed the longest diameter was more than 1 cm and solid lesions.

Exclusion criteria

1. The lesion is close to the pleural membrane
2. Refusal of participation
3. Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

ENB-GS-TBLB-X-ray Group

Experimental group

Description:

The guide sheath(GS) is introduced into the lesion via Electromagnetic Navigation System. The locatable guide(LG) and GS are confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained with fluoroscopic guidance.

Treatment:

Procedure: GS-TBLB-X-ray

Procedure: ENB

GS-TBLB-X-ray group

Active Comparator group

Description:

The GS is introduced into the lesion via the working channel of a bronchoscope with radiographic fluoroscopy. Once the location of the lesion is identified by fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.

Treatment:

Procedure: GS-TBLB-X-ray