UTB-VBN-EBUS With or Without Fluoroscopy for the Diagnosis of PPLs

Lung Cancer Clinical Trial

Official title:

Ultrathin Bronchoscopy With Virtual Bronchoscopic Navigation and Endobronchial Ultrasound for the Diagnosis of Peripheral Pulmonary Lesions Without Fluoroscopy: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02664259
• Other study ID #: SHCHE201602
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: October 2018

Study information

• Verified date: October 2018
• Source: Shanghai Chest Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: October 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Procedure:
• VBN
VBN is carried out by a VBN software(DirectPath;Olympus,Japan) which can automatically create virtual bronchoscopic images.
• EBUS
EBUS is performed using an endoscope ultrasound system , which is equipped with a 20-MHz mechanical radial-type probe (UM-S20-17S;Olympus) with an external diameter of 1.4 mm.
• X-ray
The radiograph fluoroscopy is performed when the probe is confirmed to reach the lesion by EBUS image ,cytologic and pathologic specimens are obtained under fluoroscopic guidance.

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Chest Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View 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. — View Citation

Kurimoto N, Miyazawa T, Okimasa S, Maeda A, Oiwa H, Miyazu Y, Murayama M. Endobronchial ultrasonography using a guide sheath increases the ability to diagnose peripheral pulmonary lesions endoscopically. Chest. 2004 Sep;126(3):959-65. — View Citation

Oki M, Saka H, Ando M, Asano F, Kurimoto N, Morita K, Kitagawa C, Kogure Y, Miyazawa T. Ultrathin Bronchoscopy with Multimodal Devices for Peripheral Pulmonary Lesions. A Randomized Trial. Am J Respir Crit Care Med. 2015 Aug 15;192(4):468-76. doi: 10.1164/rccm.201502-0205OC. — View Citation

Steinfort DP, Khor YH, Manser RL, Irving LB. Radial probe endobronchial ultrasound for the diagnosis of peripheral lung cancer: systematic review and meta-analysis. Eur Respir J. 2011 Apr;37(4):902-10. doi: 10.1183/09031936.00075310. Epub 2010 Aug 6. Review. — View Citation

Yoshikawa M, Sukoh N, Yamazaki K, Kanazawa K, Fukumoto S, Harada M, Kikuchi E, Munakata M, Nishimura M, Isobe H. Diagnostic value of endobronchial ultrasonography with a guide sheath for peripheral pulmonary lesions without X-ray fluoroscopy. Chest. 2007 Jun;131(6):1788-93. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The difference of complications of UTB-VBN-EBUS with fluoroscopy as compared to UTB-VBN-EBUS alone	Complications mean a composite of operation-related serious adverse events (pneumothorax,bleeding,etc.) during and after the operation in two groups.	Up to half year
Primary	The difference of diagnostic value of UTB-VBN-EBUS with fluoroscopy as compared to UTB-VBN-EBUS alone	The diagnostic value means diagnostic yields in two groups for benign and malignant lesions	Up to half year
Secondary	The difference of the operation time of UTB-VBN-EBUS with fluoroscopy as compared to UTB-VBN-EBUS alone	The operation time means the total operation time and the total EBUS time.	Up to half year