Diagnostic Value of Electromagnetic Navigation Bronchoscopy With a Guide Sheath for Peripheral Pulmonary Lesions : a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Shanghai Chest Hospital
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- The Difference of Diagnostic Value of ENB-GS-TBLB as Compared to GS-TBLB
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •clinical and imaging characteristics suggestive of maligancy
- •CT scan appearance of the PPLs showed the longest diameter was more than 1 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
Arms & Interventions
ENB-GS-TBLB-X-ray Group
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.
Intervention: ENB (Procedure)
ENB-GS-TBLB-X-ray Group
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.
Intervention: GS-TBLB-X-ray (Procedure)
GS-TBLB-X-ray group
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.
Intervention: GS-TBLB-X-ray (Procedure)
Outcomes
Primary Outcomes
The Difference of Diagnostic Value of ENB-GS-TBLB as Compared to GS-TBLB
Time Frame: Up to half year
The diagnostic yield in the ENB-GS-TBLB and GS-TBLB group was 87.2% and 61% individually.
Secondary Outcomes
- The Duration Time Difference of ENB-GS-TBLB With Fluoroscopy as Compared to GS-TBLB With Fluoroscopy Alone(Up to half year)
Investigators
Jiayuan Sun
Director, Endoscope Center, Shanghai Chest Hospita
Shanghai Chest Hospital