Clinical trial NCT02664259: UTB-VBN-EBUS With or Without Fluoroscopy for the Diagnosis of PPLs
Official title: Ultrathin Bronchoscopy With Virtual Bronchoscopic Navigation and Endobronchial Ultrasound for the Diagnosis of Peripheral Pulmonary Lesions Without Fluoroscopy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: Endobronchial ultrasonography
Peripheral pulmonary lesions
Ultrathin bronchoscopy
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2016-01-27
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the feasibility,efficacy and safety of ultrathin bronchoscopy(UTB) combined with virtual bronchoscopic navigation(VBN) and endobronchial ultrasound(EBUS) for the diagnosis of peripheral pulmonary lesions (PPLs) without radiographic fluoroscopy.

Detailed description: The investigators evaluate feasibility,efficacy and safety of UTB combined with VBN and EBUS for the diagnosis of PPLs without radiographic fluoroscopy.Bronchoscopes with a 3.0-mm distal end diameter and a 1.7-mm working channel diameter are used (BF-Y0058;Olympus).The final diagnoses are established by pathological evidence from biopsy or cytology specimen including bronchoscopy or other procedures,microbiological analysis and clinical follow-up.The study is designed as a single center prospective randomized controlled trial.The participating center is Department of endoscopy, Shanghai Chest Hospital, Shanghai Jiao Tong University, China.Subjects will be randomized (1:1) to UTB-VBN-EBUS-X-ray group and UTB-VBN-EBUS group based on a randomization schedule.The study is expected to enroll 200 patients with 100 patients of each group.

Eligibility criteria: Inclusion Criteria:

1. Patients with peripheral pulmonary lesions suspected to be cancer that need pathologically confirmed;
2. Presence of bronchus leading to or adjacent to the lesion from CT scan.

Exclusion Criteria:

1. Pure ground glass opacity (GGO) lesions;
2. Refusal of participation;
3. Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy;
4. Presence of concomitant endobronchial lesion during the brochoscopy procerdure.

Primary outcomes:
measure: The difference of diagnostic value of UTB-VBN-EBUS with fluoroscopy as compared to UTB-VBN-EBUS alone
timeFrame: Up to half year
Secondary outcomes:
measure: The difference of the operation time of UTB-VBN-EBUS with fluoroscopy as compared to UTB-VBN-EBUS alone
timeFrame: Up to half year
Other outcomes:
measure: The difference of complications of UTB-VBN-EBUS with fluoroscopy as compared to UTB-VBN-EBUS alone
timeFrame: Up to half year
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Chest Hospital
name: Jiayuan Sun, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Ishida T, Asano F, Yamazaki K, Shinagawa N, Oizumi S, Moriya H, Munakata M, Nishimura M; Virtual Navigation in Japan Trial Group. Virtual bronchoscopic navigation combined with endobronchial ultrasound to diagnose small peripheral pulmonary lesions: a randomised trial. Thorax. 2011 Dec;66(12):1072-7. doi: 10.1136/thx.2010.145490. Epub 2011 Jul 11.
citation: Asano F, Shinagawa N, Ishida T, Shindoh J, Anzai M, Tsuzuku A, Oizumi S, Morita S. Virtual bronchoscopic navigation combined with ultrathin bronchoscopy. A randomized clinical trial. Am J Respir Crit Care Med. 2013 Aug 1;188(3):327-33. doi: 10.1164/rccm.201211-2104OC.