EBUS-TBNA for Diagnosis of Mediastinal Lymphadenopathy | NCT01493739

Studies
EBUS-TBNA for Diagnosis of Mediastinal Lymphadenopathy

NCT01493739

Sponsor

Chang Gung Memorial Hospital

Status

Unknown status

Last Update Posted

Dec 16, 2011Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Mediastinal Lymphadenopathy
Lung Cancer

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Jan 2012Estimated

Completion Date

Jan 2012Estimated

First Submitted Date

Nov 21, 2011

First Submission Date that Met QC Criteria

Dec 15, 2011

First Posted Date

Dec 16, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 15, 2011

Last Update Posted Date

Dec 16, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

CHIH-HSI KUO, Principle Investigator, Consultant Physician, Respiratory Medicine Department, Chang Gung Memorial HospitalPrincipal Investigator

Lead Sponsor

Chang Gung Memorial HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims on the combinatorial results of cytology, histopathology and microbiology obatined by EBUS-TBNA for unselected mediastina lesions.

Detailed Description

A number of studies have proved EBUS-TBNA to be useful for lymph node staging in lung cancer. The diagnostic performance is equivalent to mediastinoscopy while the invasiveness is far less. This study primarily focusing on merged approach of cytology, histopathology and microbioloogy obatined by EBUS-TBNA for unselected mediastina lesions.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Label	Type	Description	Intervention Names
lymphadenopathy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnostic rate		Participant will be followed within an average of three months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 years old
mediastinal lymphadenopathy on Chest CT scan
with a short-axis > 10mm

Exclusion Criteria:

patients intolerant to bronchoscopy exam
unstable vital sign (Blood pressure, heart rate, breath rate)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with mediastinal lymphadenopathy on Chest CT scan with a short-axis > 10mm

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chih-Hsi Kuo, MD	Contact			chihhsikuo@gmail.com
Fu-Tsai Chung, MD	Contact

Overall Officials

Name	Affiliation	Role
Chih-Hso Kuo, MD	Chang Gung Memorial Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chang Gung Memorial Hospital	Recruiting	Taipei	Taipei	112	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided