NCT02268162

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,228

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 20, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

November 16, 2015

Status Verified

November 1, 2015

Enrollment Period

2.6 years

First QC Date

October 15, 2014

Last Update Submit

November 13, 2015

Conditions

Lung NeoplasmsEarly DiagnosisBronchoscopy

Keywords

Lung NeoplasmsBronchoscopyVirtual Bronchoscopic Navigation(VBN)FluoroscopyEndobronchial Ultrasonography with a Guide Sheath(EBUS-GS)Diagnosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • length of operation time using bronchoscopy or bronchoscopy combination

    30 minutes

  • length of stay in hospital

    7 days

  • hospitalization costs

    7 days

  • Number of participants with adverse events or serious adverse events

    2 weeks

Study Arms (3)

Routine Bronchoscopy

NO INTERVENTION

Participants in the group will receive routine bronchoscopy.

Routine Bronchoscopy with a guiding equipment

EXPERIMENTAL

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

Routine Bronchoscopy with two or more guiding equipments

EXPERIMENTAL

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

Interventions

guiding equipmentsPROCEDURE

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

Routine Bronchoscopy with a guiding equipmentRoutine Bronchoscopy with two or more guiding equipments

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tangdu Hospital

Xi'an, Shaanxi, 710038, China

RECRUITING

Related 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.

    PMID: 23600452BACKGROUND

  • 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.

    PMID: 23649456BACKGROUND

  • 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.

    PMID: 24587779BACKGROUND

MeSH Terms

Conditions

Lung NeoplasmsDisease

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Faguang Jin, MD & PhD

    Tang-Du Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Pan, MD & PhD

CONTACT

86-29-84778526panlei@fmmu.edu.cn

Yandong Nan, MD

CONTACT

86-29-84717533nanyandong2008@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2014

First Posted

October 20, 2014

Study Start

April 1, 2015

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

November 16, 2015

Record last verified: 2015-11

Locations

CN(1)