Diagnosis of Individuals With Pulmonary Nodules by Different Bronchoscopy Combination
NCT ID: NCT02268162
Last Updated: 2015-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
3228 participants
INTERVENTIONAL
2015-04-30
2017-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Routine Bronchoscopy
Participants in the group will receive routine bronchoscopy.
No interventions assigned to this group
Routine Bronchoscopy with a guiding equipment
Participants in the group will receive routine bronchoscopy combined with a guiding equipment. These guiding equipments include virtual bronchoscopic navigation(VBN), endobronchial ultrasonography with a guide sheath(EBUS-GS) and fluoroscopy.
guiding equipments
The guiding equipments including VBN, EBUS-GS and fluoroscopy guide a bronchoscope along the bronchial route to a peripheral pulmonary lesion.
Routine Bronchoscopy with two or more guiding equipments
Participants in the group will receive routine 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.
guiding equipments
The guiding equipments including VBN, EBUS-GS and fluoroscopy guide a bronchoscope along the bronchial route to a peripheral pulmonary lesion.
Interventions
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guiding equipments
The guiding equipments including VBN, EBUS-GS and fluoroscopy guide a bronchoscope along the bronchial route to a peripheral pulmonary lesion.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Changhai Hospital
OTHER
The First Affiliated Hospital of Guangzhou Medical University
OTHER
Xinqiao Hospital of Chongqing
OTHER
China Meitan General Hospital
OTHER
Micro-Tech (Nanjing) Co., Ltd.
INDUSTRY
Tang-Du Hospital
OTHER
Responsible Party
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Principal Investigators
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Faguang Jin, MD & PhD
Role: PRINCIPAL_INVESTIGATOR
Tang-Du Hospital
Locations
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Tangdu Hospital
Xi'an, Shaanxi, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Other Identifiers
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201402024
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
lungcancer diagnosis
Identifier Type: -
Identifier Source: org_study_id
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