ENB-GS-TBLB for the Diagnosis of PPLs

Lung Cancer Clinical Trial

Official title:

Diagnostic Value of Electromagnetic Navigation Bronchoscopy With a Guide Sheath for Peripheral Pulmonary Lesions : a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02207478
• Other study ID #: SHCHE201401
• Status: Completed
• Phase: N/A
• First received: August 1, 2014
• Last updated: October 28, 2015
• Start date: July 2014
• Est. completion date: April 2015

Study information

• Verified date: October 2015
• Source: Shanghai Chest Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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) .

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Procedure:
• ENB
ENB is performed using an electromagnetic navigation system (LK-DW-NK-Z; Suzhou Lungcare Medical Technology Inc., China) with an internal locatable guide (LG; Lungcare) with diameter of 1.45 mm. Bronchoscopes with a working channel diameter of 2.0 mm are used (BF-260 and BF-P260F; Olympus, Japan). The LG is inserted into the GS(K-201; Olympus) beforehand, and the GS-covered LG is introduced via the working channel of the bronchoscope and navigated to the PPL finally. The LG and GS are confirmed to reach the lesion by radiograph fluoroscopy.
• GS-TBLB-X-ray
A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Chest Hospital	Fudan University

Country where clinical trial is conducted

China, 

References & Publications (3)

Baaklini WA, Reinoso MA, Gorin AB, Sharafkaneh A, Manian P. Diagnostic yield of fiberoptic bronchoscopy in evaluating solitary pulmonary nodules. Chest. 2000 Apr;117(4):1049-54. — View Citation

Gex G, Pralong JA, Combescure C, Seijo L, Rochat T, Soccal PM. Diagnostic yield and safety of electromagnetic navigation bronchoscopy for lung nodules: a systematic review and meta-analysis. Respiration. 2014;87(2):165-76. doi: 10.1159/000355710. Epub 2014 Jan 3. Review. — View Citation

Wang Memoli JS, Nietert PJ, Silvestri GA. Meta-analysis of guided bronchoscopy for the evaluation of the pulmonary nodule. Chest. 2012 Aug;142(2):385-93. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Difference of Diagnostic Value of ENB-GS-TBLB as Compared to GS-TBLB	The diagnostic yield in the ENB-GS-TBLB and GS-TBLB group was 87.2% and 61% individually.	Up to half year	No
Secondary	The Duration Time Difference of ENB-GS-TBLB With Fluoroscopy as Compared to GS-TBLB With Fluoroscopy Alone	Including total procedure time,total X-ray time, duration time for finding lesions and X-ray time for finding lesions.	Up to half year	No