Diagnosis of Individuals With Pulmonary Nodules by Different Bronchoscopy Combination

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

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.

Study Overview

• Status: Unknown
• Conditions: Lung Neoplasms; Bronchoscopy; Early Diagnosis
• Intervention / Treatment: Procedure: guiding equipments

• Study Type: Interventional
• Enrollment (Anticipated): 3228
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yandong Nan, MD; Phone Number: 86-29-84717533; Email: nanyandong2008@163.com
• Study Contact Backup: Name: Lei Pan, MD & PhD; Phone Number: 86-29-84778526; Email: panlei@fmmu.edu.cn

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710038
      • Recruiting
      • Tangdu Hospital
      • Contact: Lei Pan, Ph.D, MD; Phone Number: 86-29-84778526; Email: panlei@fmmu.edu.cn
      • Contact: Yandong Nan, MD; Phone Number: 86-29-84717533; Email: nanyandong@163.com
      • Principal Investigator: Lei Pan, Ph.D, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Routine Bronchoscopy; Participants in the group will receive routine bronchoscopy.
Experimental: 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.	Procedure: guiding equipments; The guiding equipments including VBN, EBUS-GS and fluoroscopy guide a bronchoscope along the bronchial route to a peripheral pulmonary lesion.
Experimental: 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.	Procedure: guiding equipments; The guiding equipments including VBN, EBUS-GS and fluoroscopy guide a bronchoscope along the bronchial route to a peripheral pulmonary lesion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of operation time using bronchoscopy or bronchoscopy combination	The operation time using bronchoscopy or bronchoscopy combination to examine a participant	30 minutes
length of stay in hospital	length of stay in hospital for a participant	7 days
hospitalization costs	the hospitalization costs for a participant	7 days
Number of participants with adverse events or serious adverse events	Number of participants with any adverse events or serious adverse events	2 weeks

Collaborators and Investigators

• Sponsor: Tang-Du Hospital
• Collaborators: Changhai Hospital; The First Affiliated Hospital of Guangzhou Medical University; Xinqiao Hospital of Chongqing; China Meitan General Hospital; Micro-Tech (Nanjing) Co., Ltd.
• Investigators: Principal Investigator: Faguang Jin, MD & PhD, Tang-Du Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): November 1, 2017
• Study Completion (Anticipated): November 1, 2017

Study Registration Dates

• First Submitted: October 15, 2014
• First Submitted That Met QC Criteria: October 15, 2014
• First Posted (Estimate): October 20, 2014

Study Record Updates

• Last Update Posted (Estimate): November 16, 2015
• Last Update Submitted That Met QC Criteria: November 13, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Bronchoscopy; Diagnosis; Fluoroscopy; Lung Neoplasms; Virtual Bronchoscopic Navigation(VBN); Endobronchial Ultrasonography with a Guide Sheath(EBUS-GS)
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Disease; Multiple Pulmonary Nodules
• Other Study ID Numbers: lungcancer diagnosis; 201402024 (Other Grant/Funding Number: Ministry of Health in China)