UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical impact of EUS and EUS-FNA of bilateral adrenal glands in patients with potentially resectable lung cancer
Title of the study (Brief title)	EUS-FNA of bilateral adrenal glands in lung cancer patients
Region	Japan

Condition
Condition	lung cancer
Classification by specialty	Gastroenterology Pneumology Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the clinical impact of EUS and EUS-FNA of bilateral adrenal glands in potentially resectable lung cancer patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	To assess the detection rate of right adrenal gland by EUS and to compare the accuracy between CT, PET-CT and EUS/EUS-FNA for adrenal metastases.
Key secondary outcomes	To compare the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) between CT, PET-CT and EUS/EUS-FNA for adrenal metastases. To evaluate the incidence of EUS/EUS-FNA related complications.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	Consecutive patients with potentially resectable lung cancer who underwent EUS/EUS-FNA for staging of lung cancer at the Gifu University Hospital between October 2009 and September 2011.
Key exclusion criteria	The exclusion criteria were patients with poor medical conditions of grades 4 and 5 according to the American Society of Anesthesiologists Physical Status classification system, and patients with bleeding tendency and coagulopathy.
Target sample size	150

Research contact person
Name of lead principal investigator	Ichiro Yasuda
Organization	Gifu University Hospital
Division name	First Dept. of Internal Medicine
Address	1-1 Yanagido, Gifu 501-1194
TEL	058-230-6308
Email	yasudaich@gmail.com

Public contact
Name of contact person	Shinya Uemura
Organization	Gifu University Hospital
Division name	First Dept. of Internal Medicine
Address	1-1 Yanagido, Gifu 501-1194
TEL	058-230-6308
Homepage URL
Email	ueshin550621@gmail.com

Sponsor
Institute	First Dept. of Internal Medicine, Gifu University Hospital
Institute
Department

Funding Source
Organization	First Dept. of Internal Medicine, Gifu University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	National Hospital Organization Nagara Medical Center
Name of secondary funｄer(s)

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	岐阜大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2012 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 03 Month 27 Day
Anticipated trial start date	2012 Year 04 Month 01 Day
Last follow-up date	2012 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	We retrospectively collected the data of consecutive patients with potentially resectable lung cancer who underwent EUS/EUS-FNA for staging of lung cancer at the Gifu University Hospital between October 2009 and September 2011.

Management information
Registered date	2012 Year 03 Month 27 Day
Last modified on	2018 Year 02 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008956