Diagnosis of Individuals With Pulmonary Nodules by Different Bronchoscopy Combination

Lung Neoplasms Clinical Trial

Official title:

Prospective Multicenter Randomized Control Study on Diagnosis of Individuals With Pulmonary Nodules by Different Bronchoscopy Combination

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02268162
• Other study ID #: lungcancer diagnosis
• Secondary ID: 201402024
• Status: Recruiting
• Phase: N/A
• First received: October 15, 2014
• Last updated: November 13, 2015
• Start date: April 2015
• Est. completion date: November 2017

Study information

• Verified date: November 2015
• Source: Tang-Du Hospital
• Contact: Lei Pan, MD & PhD
• Phone: 86-29-84778526
• Email: panlei[@]fmmu.edu.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3228
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bronchoscopy
• Early Diagnosis
• Lung Neoplasms
• Multiple Pulmonary Nodules

Intervention

Procedure:
• guiding equipments
The guiding equipments including VBN, EBUS-GS and fluoroscopy guide a bronchoscope along the bronchial route to a peripheral pulmonary lesion.

Locations

Country	Name	City	State
China	Tangdu Hospital	Xi'an	Shaanxi

Sponsors (6)

Lead Sponsor	Collaborator
Tang-Du Hospital	Changhai Hospital, China Meitan General Hospital, Micro-Tech (Nanjing) Co., Ltd., The First Affiliated Hospital of Guangzhou Medical University, Xinqiao Hospital of Chongqing

Country where clinical trial is conducted

China, 

References & Publications (3)

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

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-120S. doi: 10.1378/chest.12-2351. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic yield for pulmonary peripheral lesions	The diagnostic yield for individuals with pulmonary peripheral lesions examined by bronchoscopy with or without guiding equipments	7 days	No
Secondary	length of operation time using bronchoscopy or bronchoscopy combination	The operation time using bronchoscopy or bronchoscopy combination to examine a participant	30 minutes	No
Secondary	length of stay in hospital	length of stay in hospital for a participant	7 days	No
Secondary	hospitalization costs	the hospitalization costs for a participant	7 days	No
Secondary	Number of participants with adverse events or serious adverse events	Number of participants with any adverse events or serious adverse events	2 weeks	No