ENB-GS-TBLB for the Diagnosis of PPLs

Not Applicable

Completed

• Conditions: Lung Cancer
• Interventions: Procedure: ENB; Procedure: GS-TBLB-X-ray

• Registration Number: NCT02207478
• Lead Sponsor: Shanghai Chest Hospital

Brief Summary

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) .

Detailed 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).

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-08-01
• Study First Submitted QC: 2014-08-01
• Study First Posted: 2014-08-04
• Primary Completion: 2015-03
• Study Completion: 2015-04
• Results First Submitted: 2015-09-23
• Status Verified: 2015-10
• Results First Submitted QC: 2015-10-28
• Last Update Submitted: 2015-10-28
• Results First Posted: 2015-11-30
• Last Update Posted: 2015-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ENB-GS-TBLB-X-ray Group	GS-TBLB-X-ray	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.
GS-TBLB-X-ray group	GS-TBLB-X-ray	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.
ENB-GS-TBLB-X-ray Group	ENB	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.

Primary Outcome Measures

Name	Time	Method
The Difference of Diagnostic Value of ENB-GS-TBLB as Compared to GS-TBLB	Up to half year	The diagnostic yield in the ENB-GS-TBLB and GS-TBLB group was 87.2% and 61% individually.

Secondary Outcome Measures

Name	Time	Method
The Duration Time Difference of ENB-GS-TBLB With Fluoroscopy as Compared to GS-TBLB With Fluoroscopy Alone	Up to half year	Including total procedure time，total X-ray time, duration time for finding lesions and X-ray time for finding lesions.

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, China