Clinical trial NCT03628222: Transbronchial Lung Biopsy Guided by ENB
Official title: Transbronchial Lung Biopsy Guided by Electromagnetic Navigation Bronchoscopy: A Prospective, Randomized, Multicenter, Superiority Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Lesion(s) Requiring Evaluation
Keywords: Lung lesion
Electromagnetic navigation bronchoscopy (ENB)
Transbronchial lung biopsy(TBLB)
bronchoscopy
Lead sponsor: Changzhou LungHealth Medtech Company Limited
Sponsor class: INDUSTRY
First posted: 2018-08-14
Enrollment: 226
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 performance and safety of electromagnetic navigation bronchoscopy (ENB) system and system kit (iLungTM SuperNavigator) .

Detailed description: This is prospective, randomized, multicenter, superiority study. 8 top centers in China was chosen. Subject which has peripheral lung lesions (PLLs) detected by chest CT scan, requires biopsy diagnosis, and meets all inclusion and exclusion criteria, will be included in this trial. Firstly physician determines the lesion biopsied, then the subject will be randomized to experimental or control group. The experimental group is treated with ENB guided transbronchial lung biopsy (TBLB)(ENB-TBLB): Under ENB guidance, the location sensor reaches the edge of the lesion, and X-ray is used for actual distance confirmation, if physician determines the distance is enough for biopsy, TBLB will be conducted. The control group will be treated with TBLB using X-ray guidance.

Eligibility criteria: Inclusion Criteria:

* 18 years and older;
* Subject presents with PLL(s) detected by chest CT scan and biopsy diagnosis is needed;
* Subject is willing to receive bronchoscopy voluntarily, and meets relevant requirements;
* Subject or their guardian understands the purpose of this trial, and willing to participate in the trial voluntarily and sign Informed Consent Form (ICF).

Exclusion Criteria:

* Subject has participated in a drug or device study (drug study within 3 months or device study within 1 month);
* Female subject who is pregnant or nursing;
* Allergic to anesthetic;
* Bronchoscopy contraindications, include: Active hemoptysis; Newly developed myocardial infarction or unstable angina attack; Severe cardiac and pulmonary dysfunction; Severe hypertension and arrhythmia; Uncorrectable bleeding tendency (Such as severe clotting dysfunction, uremia, and severe pulmonary hypertension, etc.); Severe superior vena cava obstructive syndrome; Suspected aortic aneurysm; Multiple lung bullae; Extremely exhausted systemic conditions;
* Subject with serious lung disease (Such as: severe bronchiectasis, severe emphysema, etc) ,which investigator considers not appropriate for this examination;
* Subject with implanted pacemaker or defibrillator;
* Lack of patient cooperation for bronchoscopy, such as patient with mental disorders, dysgnosia, psychological disorder etc;
* Conditions investigator considers not appropriate for this trial.

Primary outcomes:
measure: Compare the diagnostic yield of ENB-TBLB with that of X-ray-TBLB
timeFrame: Up to 6 months
Secondary outcomes:
measure: Incidence of navigation success
timeFrame: At 1 day of ENB procedure
measure: Lesion detection rate
timeFrame: About 3-7days after ENB or X-ray procedure
measure: Navigation time
timeFrame: At 1 day of ENB or X-ray procedure
measure: Evaluate the user satisfaction of ENB system and system kit
timeFrame: At 1 day of ENB procedure
measure: The adverse events and device defects related to the ENB system and system kit
timeFrame: Up to 3 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical sciences
state: Beijing
city: Quanzhou
country: China
facility: The second affiliated hospital, Fujian Medical University
state: Fujian
city: Guangzhou
country: China
facility: The First Affiliate Hospital of Guangzhou Medical University
state: Guangdong
city: Suzhou
country: China
facility: The first affiliated hospital of Suzhou University
state: Jiangsu
city: Shanghai
country: China
facility: Shanghai Chest hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
city: Hangzhou
country: China
facility: The first affiliated hospital, Zhejiang university
state: Zhejiang
Study officials:
affiliation: The First Affiliate Hospital of Guangzhou Medical University
name: Shiyue Li
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mahajan AK, Patel S, Hogarth DK, Wightman R. Electromagnetic navigational bronchoscopy: an effective and safe approach to diagnose peripheral lung lesions unreachable by conventional bronchoscopy in high-risk patients. J Bronchology Interv Pulmonol. 2011 Apr;18(2):133-7. doi: 10.1097/LBR.0b013e318216cee6.
citation: Mukherjee S, Chacey M. Diagnostic Yield of Electromagnetic Navigation Bronchoscopy Using a Curved-tip Catheter to Aid in the Diagnosis of Pulmonary Lesions. J Bronchology Interv Pulmonol. 2017 Jan;24(1):35-39. doi: 10.1097/LBR.0000000000000326.
citation: Lamprecht B, Porsch P, Wegleitner B, Strasser G, Kaiser B, Studnicka M. Electromagnetic navigation bronchoscopy (ENB): Increasing diagnostic yield. Respir Med. 2012 May;106(5):710-5. doi: 10.1016/j.rmed.2012.02.002. Epub 2012 Mar 3.
citation: Rivera MP, Mehta AC, Wahidi MM. Establishing the diagnosis of lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e142S-e165S. doi: 10.1378/chest.12-2353.