UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017040 |
|---|---|
| Receipt number | R000019760 |
| Scientific Title | Randomized study of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) versus transesophageal endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) for histological diagnosis of sarcoidosis |
| Date of disclosure of the study information | 2015/04/05 |
| Last modified on | 2020/04/06 09:17:22 |
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Basic information
Public title
Randomized study of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) versus transesophageal endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) for histological diagnosis of sarcoidosis
Acronym
Comparison of EBUS-TBNA versus EUS-FNA for diagnosing sarcoidosis
Scientific Title
Randomized study of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) versus transesophageal endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) for histological diagnosis of sarcoidosis
Scientific Title:Acronym
Comparison of EBUS-TBNA versus EUS-FNA for diagnosing sarcoidosis
Region
| Japan |
Condition
Condition
Sarcoidosis
Classification by specialty
| Gastroenterology | Pneumology | Chest surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the accuracy, tolerance and safety of EBUS-TBNA versus EUS-FNA for the diagnosis of sarcoidosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Sensitivity for histological diagnosis of sarcoidosis
Key secondary outcomes
1. Sensitivity for cytological diagnosis of sarcoidosis
2. Overall sensitivity for the diagnosis of sarcoidosis (cytology and histology)
3. Overall diagnostic yield
4. Tolerance assessed by visual analog scale (discomfort, anxiety, satisfaction, coughing, vomiting, pain, dyspnea, willing to repeat procedure)
5. Time of procedure
6. Frequency of complications
7. Oxygen demand
8. Doses of sedative and anesthetic
9. Number of evaluable lymph nodes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
EBUS-TBNA
Interventions/Control_2
EUS-FNA
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with suspected stage I/II sarcoidosis based on clinicoradiological pictures who have hilar-mediastinal nodes 10 mm or greater in short-axis diameter on CT
2. 20 years or older
3. Informed consent
Key exclusion criteria
1. Serious concomitant medical illness
2. SPO2<90% with supplemental oxygen
3. Obvious bleeding tendency
4. Pregnancy
5. Other presumed difficulties for patients in this study
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahide Oki |
Organization
Nagoya Medical Center
Division name
Department of Respiratory Medicine
Zip code
Address
4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan
TEL
052-951-1111
masahideo@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahide Oki |
Organization
Nagoya Medical Center
Division name
Department of Respiratory Medicine
Zip code
Address
4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan
TEL
052-951-1111
Homepage URL
masahideo@gmail.com
Sponsor or person
Institute
Nagoya Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立病院機構名古屋医療センター (愛知県)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2015 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 03 | Day |
Last modified on
| 2020 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019760
