UMIN-CTR Clinical Trial

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
Email	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
Email	masahideo@gmail.com

Sponsor
Institute	Nagoya Medical Center
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019760