Clinical trial NCT02268162: Diagnosis of Individuals With Pulmonary Nodules by Different Bronchoscopy Combination
Official title: Prospective Multicenter Randomized Control Study on Diagnosis of Individuals With Pulmonary Nodules by Different Bronchoscopy Combination
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Neoplasms
Early Diagnosis
Bronchoscopy
Keywords: Lung Neoplasms
Bronchoscopy
Virtual Bronchoscopic Navigation(VBN)
Fluoroscopy
Endobronchial Ultrasonography with a Guide Sheath(EBUS-GS)
Diagnosis
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
Collaborators: name: Changhai Hospital
name: The First Affiliated Hospital of Guangzhou Medical University
name: Xinqiao Hospital of Chongqing
name: China Meitan General Hospital
name: Micro-Tech (Nanjing) Co., Ltd.
First posted: 2014-10-20
Enrollment: 3228
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study evaluates the value of different bronchoscopy combination for diagnosing peripheral pulmonary lesions suspected to be cancer. One-third of participants will receive routine bronchoscopy, while one-third of participants will receive bronchoscopy combined with a guiding equipment and the other one-third of participants will receive bronchoscopy combined with two or more guiding equipments. These guiding equipments include virtual bronchoscopic navigation(VBN), endobronchial ultrasonography with a guide sheath(EBUS-GS) and fluoroscopy.


Eligibility criteria: Inclusion Criteria:

* Eligible subjects are adults with solitary peripheral pulmonary lesions (mean diameter, ≤30mm and \>8mm from axial CT images) suspected to be cancer but were not pathologically confirmed.

Exclusion Criteria:

* Patient has dysrhythmia or cardiovascular disease that poses a risk during exercise.
* Patient has uncontrollable hypertension (SBP \> 180mmHg).
* Patient has severe organ dysfunction (shock, severe hepatic and renal dysfunction, massive hemorrhage of upper gastrointestine, diffuse intravascular coagulation(DIC) and massive hemoptysis,etc).
* Patient has blood coagulation disorders (PT\>2 times the upper limit of normal(ULN) or Platelet(PLT)\<50000/ul）.
* Patient has severe dyspnea.
* Patient is allergic to local anesthetic.
* Patient is unable to provide informed consent.
* Patient is not an appropriate candidate for of is unable to tolerate flexible bronchoscopy procedures.
* Patient has any disease or condition that interferes with completion of initial or follow-up assessments of the effectiveness endpoints.
* Patient has demonstrated unwillingness or inability to complete screening or baseline data collection procedures.
* Patient participated in a study of an investigational drug or device within the past 30 days prior to participation in this study, or is currently participating in another clinical study.
* Female patient of childbearing potential has a positive result from a pregnancy test.

Primary outcomes:
measure: Diagnostic yield for pulmonary peripheral lesions
timeFrame: 7 days
Secondary outcomes:
measure: length of operation time using bronchoscopy or bronchoscopy combination
timeFrame: 30 minutes
measure: length of stay in hospital
timeFrame: 7 days
measure: hospitalization costs
timeFrame: 7 days
measure: Number of participants with adverse events or serious adverse events
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Tangdu Hospital
state: Shaanxi
Study officials:
affiliation: Tang-Du Hospital
name: Faguang Jin, MD & PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Gould MK, Donington J, Lynch WR, Mazzone PJ, Midthun DE, Naidich DP, Wiener RS. Evaluation of individuals with pulmonary nodules: when is it 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):e93S-e120S. doi: 10.1378/chest.12-2351.
citation: Shinohara S, Hanagiri T, Takenaka M, Chikaishi Y, Oka S, Shimokawa H, Nakagawa M, Uramoto H, So T, Aoki T, Tanaka F. Evaluation of undiagnosed solitary lung nodules according to the probability of malignancy in the American College of Chest Physicians (ACCP) evidence-based clinical practice guidelines. Radiol Oncol. 2014 Jan 22;48(1):50-5. doi: 10.2478/raon-2013-0064. eCollection 2014 Mar.