UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of contrast-enhanced endoscopic ultrasonography for diagnosing abdominal or mediastinal enlarged lymph nodes: muticenter pilot study
Title of the study (Brief title)	CE-EUS for enlarged LN
Region	Japan

Condition
Condition	enlarged mediastinal or abdominal LN
Classification by specialty	Hepato-biliary-pancreatic medicine Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aims of this study are to assess difference of finding of CE-EUS in enlarged abdominal or mediastinal lymph nodesbetween diseases
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Diagnostic ability by using qualitative evaluation of contrast-enhanced endoscopic ultrasonography
Key secondary outcomes	To assess the usefulness of quantitative evaluation by using TIC analysis

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Maneuver
Interventions/Control_1	Contrast-enhanced endoscopic ultrasonography
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	1)Patient with enlarged lymph nodes around upper gastrointestinal tract by imaging study 2)Patient who will undergo endoscopic ultrasound-guided fine-needle aspiration for enlarged lymph nodes 3)ECOG performance status = 0-2 4)Written informed consent
Key exclusion criteria	1) Inappropriate to perform endoscopic ultrasonography 2) Blood coagulation disorder or decreased platelet counts. Taking anticoagulant or anti-platelet drugs 3) Allergy to eggs 4) possible pregnancy 5) Failure of other organs (ASA:Grade3,4)
Target sample size	100

Research contact person
Name of lead principal investigator	Takuji Iwashita
Organization	Gifu University Hospital
Division name	First Department of Internal Medicine
Address	1-1 Yanagido, Gifu, Japan
TEL	058-230-6308
Email	takuji-guh@umin.ac.jp

Public contact
Name of contact person	Takuji Iwashita
Organization	Gifu University Hospital
Division name	First Department of Internal Medicine
Address	1-1 Yanagido, Gifu, Japan
TEL	058-230-6308
Homepage URL
Email	takuji-guh@umin.ac.jp

Sponsor
Institute	Gifu University Hospital
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)

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	岐阜市民病院(Gifu Municipal Hospital) 岐阜県総合医療センター(GIFU PREFECTURAL GENERAL MEDICAL CENTER)

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 04 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 08 Month 01 Day
Anticipated trial start date	2016 Year 09 Month 01 Day
Last follow-up date
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

Management information
Registered date	2016 Year 10 Month 04 Day
Last modified on	2018 Year 10 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027983