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Diagnosis of Individuals With Pulmonary Nodules by Different Bronchoscopy Combination

Primary Purpose

Lung Neoplasms, Early Diagnosis, Bronchoscopy

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

guiding equipments

About this trial

This is an interventional diagnostic trial for Lung Neoplasms focused on measuring Lung Neoplasms, Bronchoscopy, Virtual Bronchoscopic Navigation(VBN), Fluoroscopy, Endobronchial Ultrasonography with a Guide Sheath(EBUS-GS), Diagnosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Tangdu HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Arm Label

Routine Bronchoscopy

Routine Bronchoscopy with a guiding equipment

Routine Bronchoscopy with two or more guiding equipments

Arm Description

Participants in the group will receive routine bronchoscopy.

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.

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.

Outcomes

Primary Outcome Measures

Diagnostic yield for pulmonary peripheral lesions

The diagnostic yield for individuals with pulmonary peripheral lesions examined by bronchoscopy with or without guiding equipments

Secondary Outcome Measures

length of operation time using bronchoscopy or bronchoscopy combination

The operation time using bronchoscopy or bronchoscopy combination to examine a participant

length of stay in hospital

length of stay in hospital for a participant

hospitalization costs

the hospitalization costs for a participant

Number of participants with adverse events or serious adverse events

Number of participants with any adverse events or serious adverse events

Full Information

NCT ID

NCT02268162

First Posted

October 15, 2014

Last Updated

November 13, 2015

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.

1. Study Identification

Unique Protocol Identification Number

NCT02268162

Brief Title

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

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Unknown status

Study Start Date

April 2015 (undefined)

Primary Completion Date

November 2017 (Anticipated)

Study Completion Date

November 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the 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.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Neoplasms, Early Diagnosis, Bronchoscopy

Keywords

Lung Neoplasms, Bronchoscopy, Virtual Bronchoscopic Navigation(VBN), Fluoroscopy, Endobronchial Ultrasonography with a Guide Sheath(EBUS-GS), Diagnosis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

3228 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Routine Bronchoscopy

Arm Type

No Intervention

Arm Description

Participants in the group will receive routine bronchoscopy.

Arm Title

Routine Bronchoscopy with a guiding equipment

Arm Type

Experimental

Arm Description

Arm Title

Routine Bronchoscopy with two or more guiding equipments

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

guiding equipments

Intervention Description

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

Primary Outcome Measure Information:

Title

Diagnostic yield for pulmonary peripheral lesions

Description

The diagnostic yield for individuals with pulmonary peripheral lesions examined by bronchoscopy with or without guiding equipments

Time Frame

7 days

Secondary Outcome Measure Information:

Title

length of operation time using bronchoscopy or bronchoscopy combination

Description

The operation time using bronchoscopy or bronchoscopy combination to examine a participant

Time Frame

30 minutes

Title

length of stay in hospital

Description

length of stay in hospital for a participant

Time Frame

7 days

Title

hospitalization costs

Description

the hospitalization costs for a participant

Time Frame

7 days

Title

Number of participants with adverse events or serious adverse events

Description

Number of participants with any adverse events or serious adverse events

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lei Pan, MD & PhD

Phone

86-29-84778526

panlei@fmmu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Yandong Nan, MD

Phone

86-29-84717533

nanyandong2008@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Faguang Jin, MD & PhD

Organizational Affiliation

Tang-Du Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tangdu Hospital

City

Xi'an

State/Province

Shaanxi

ZIP/Postal Code

710038

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lei Pan, Ph.D, MD

Phone

86-29-84778526

panlei@fmmu.edu.cn

First Name & Middle Initial & Last Name & Degree

Yandong Nan, MD

Phone

86-29-84717533

nanyandong@163.com

First Name & Middle Initial & Last Name & Degree

Lei Pan, Ph.D, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

23600452

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.

Results Reference

background

PubMed Identifier

23649456

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.

Results Reference

background

PubMed Identifier

24587779

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.

Results Reference

background

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Diagnosis of Individuals With Pulmonary Nodules by Different Bronchoscopy Combination

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