Clinical trial NCT04056273: Assess the Use of rEBUS With a Guide Sheath to Increase Transbronchial Lung Biopsy Yield Rate
Official title: Assessment of the Use of Radial Endobronchial Ultrasonography With a Guide Sheath in Increasing the Yield Rate of Transbronchial Lung Biopsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diagnoses Disease
Lung Tumor
Keywords: guide sheath, bronchoscopic biopsy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-08-14
Enrollment: 586
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Whether using a guide sheath can increase the diagnostic yield rate after the lesion is located by radial endobronchial ultrasound

Detailed description: For lung nodules, there are several ways to acquire tissue for pathology study, including computed tomography (CT)-guided core needle biopsy, radial probe endobronchial ultrasound (rEBUS)-guided transbronchial lung biopsy (TBLB), convex probe EBUS transbronchial needle aspiration (TBNA), and echo-guided core needle biopsy. rEBUS-guided TBLB has relatively low limitation of lesion position, comparing to echo-guided core needle biopsy and EBUS-TBNA, and doesn't need to deal with the risk of radiation exposure.1 For peripheral pulmonary lesions (PPL), it has good yield rate and the operation is easy.2 However, when bleeding occurs, the procedure time is prolonged for hemostasis. Nonetheless, using a guide sheath can help with the problem. According to the literatures, biopsy yield rates vary but on average it is higher with a guide sheath (62\~90% vs. 41\~73%), while the complication rates are about the same (1.3\~4.4% 1.5\~5.0%). The investigators would like to know whether the diagnostic rate is higher with a guide sheath and so do the procedure time and the complication rate. Whether the lesion character affect the yield rate will also be studied.

Eligibility criteria: Inclusion Criteria:

Age ≥ 20 years old. Radiographic evidence of peripheral pulmonary lesions. The lesion can be located by radial probe EBUS.

Exclusion Criteria:

B1 bronchus. Thrombocytopenia with platelet count \< 100K. Coagulopathy with INR \> 1.3. High oxygen demand (O2 mask \> 28%, 5L). Currently using anti-platelet drug or anti-coagulant.

Primary outcomes:
measure: The diagnostic yield rate i. Brushing cytology ii. Biopsy
timeFrame: 2 years
Secondary outcomes:
measure: Procedure duration
timeFrame: 1 year
measure: Complication rate (pneumothorax, hemoptysis)
timeFrame: 1 year
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chao-Chi Ho
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dhooria S, Sehgal IS, Gupta N, Aggarwal AN, Behera D, Agarwal R. Role of radial endobronchial ultrasound-guided transbronchial needle aspiration in the diagnosis of pulmonary nodules: Case report and literature review. Lung India. 2017 Jan-Feb;34(1):61-64. doi: 10.4103/0970-2113.197094.
citation: Eom JS, Mok JH, Kim I, Lee MK, Lee G, Park H, Lee JW, Jeong YJ, Kim WY, Jo EJ, Kim MH, Lee K, Kim KU, Park HK. Radial probe endobronchial ultrasound using a guide sheath for peripheral lung lesions in beginners. BMC Pulm Med. 2018 Aug 13;18(1):137. doi: 10.1186/s12890-018-0704-7.
citation: Hayama M, Okamoto N, Suzuki H, Tamiya M, Shiroyama T, Tanaka A, Nishida T, Nishihara T, Uehara N, Morishita N, Kawahara K, Hirashima T. Radial endobronchial ultrasound with a guide sheath for diagnosis of peripheral cavitary lung lesions: a retrospective study. BMC Pulm Med. 2016 May 11;16(1):76. doi: 10.1186/s12890-016-0244-y.