Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2014-07-31
2015-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. CT scan appearance of the PPLs showed the longest diameter was more than 1 cm and solid lesions.
Exclusion Criteria
2. Refusal of participation
3. Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy
18 Years
80 Years
ALL
No
Sponsors
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Fudan University
OTHER
Shanghai Chest Hospital
OTHER
Responsible Party
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Jiayuan Sun
Director, Endoscope Center, Shanghai Chest Hospita
Principal Investigators
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Jiayuan Sun, MD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Chest Hospital
Locations
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Shanghai Chest Hospital
Shanghai, , China
Countries
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References
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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.
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. doi: 10.1378/chest.117.4.1049.
Wang Memoli JS, Nietert PJ, Silvestri GA. Meta-analysis of guided bronchoscopy for the evaluation of the pulmonary nodule. Chest. 2012 Aug;142(2):385-393. doi: 10.1378/chest.11-1764.
Other Identifiers
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SHCHE201401
Identifier Type: -
Identifier Source: org_study_id