A prospective observational study on the diagnostic yield and safety of bronchoscopy guided by a Mobile 3D C-arm system for ground-glass opacity predominant lesions under moderate or deep sedation with spontaneous breathing.

A prospective observational study on the diagnostic yield and safety of bronchoscopy guided by a Mobile 3D C-arm system for ground-glass opacity predominant lesions under moderate or deep sedation with spontaneous breathing. - A study on the utility of bronchoscopy guided by a Mobile 3D C-arm system for ground-glass opacity predominant lesions

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000057296

Enrollment

Registered

2025-03-17

Start date

2025-03-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung tumor

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Having a small GGO-predominant pulmonary lesion suspected to be a lung tumor with a lesion diameter of 30 mm or less. Planning to undergo diagnostic bronchoscopy using a Mobile 3D C-arm system under moderate to deep sedation while maintaining spontaneous breathing for the diagnosis of the above lesion. Being 20 years of age or older at the time of obtaining consent. Having provided written informed consent for participation in this study.

Exclusion criteria

Exclusion criteria: Cases where bronchoscopy is considered difficult due to a severe condition. Cases with a history of hypersensitivity to lidocaine, midazolam, or fentanyl. Cases with liver disease or blood disorders associated with coagulation abnormalities. Cases undergoing antiplatelet or anticoagulant therapy where appropriate drug withdrawal is difficult. Cases of pregnancy. Other cases where the attending physician deems the subject unsuitable for participation.

Design outcomes

Primary

Measure	Time frame
Total diagnostic yield	—

Secondary

Measure	Time frame
Tissue diagnostic yield, cytology diagnostic yield, lesion access yield using 3D imaging, comparison of lesion access between radial EBUS findings and 3D imaging, procedure time, radiation exposure, number of scans, complications, feasibility and results of genetic testing for lung cancer, and diagnostic yield and lesion access yield using 3D imaging in subgroups (lesion size, location, presence or absence of CT bronchus sign, lesion characteristics, presence or absence of CPAP/pressure support, type of bronchoscope used, presence or absence of cryobiopsy, etc.).	—

Measure

Time frame

Tissue diagnostic yield, cytology diagnostic yield, lesion access yield using 3D imaging, comparison of lesion access between radial EBUS findings and 3D imaging, procedure time, radiation exposure, number of scans, complications, feasibility and results of genetic testing for lung cancer, and diagnostic yield and lesion access yield using 3D imaging in subgroups (lesion size, location, presence or absence of CT bronchus sign, lesion characteristics, presence or absence of CPAP/pressure support, type of bronchoscope used, presence or absence of cryobiopsy, etc.).

—

Countries

Japan

Contacts

Public ContactTadashi Sakaguchi

Matsusaka Municipal Hospital Department of Respiratory Medicine

mchsakaguchi@city-hosp.matsusaka.mie.jp0598231515

Outcome results