UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Utility of contrast-enhanced harmonic endoscopic ultrasonography for differential diagnosis of malignant from benign lymphadenopathy: a prospective study
Title of the study (Brief title)	Utility of contrast-enhanced harmonic endoscopic ultrasonography for differential diagnosis of malignant from benign lymphadenopathy: a prospective study
Region	Japan

Condition
Condition	Pancreatic carcinoma, Biliary carcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This cohort study aimed to compare the diagnostic accuracy of contrast-enkhanecd harmonic EUS, standard EUS and color Doppler EUS in terms of differentiating malignant from benign lymph nodes.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To compare the diagnostic accuracy of standard EUS, color Doppler EUS and CH-EUS in terms of the ability to differentiate malignant nodes from benign nodes.
Key secondary outcomes	To compare the accuracy of CH-EUS and EUS-FNA in terms of N-stage diagnosis

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	100 years-old >
Gender	Male and Female
Key inclusion criteria	Cases with lymphadenopathy detected by EUS Cases with pancreatobiliary tumors confirmed by the other imag9ng methods. Written informed consent ECOG performance stautus = 0-2
Key exclusion criteria	Inapropriate to perform endoscopic ultrasonography Faiulre of other organs (ASA: Grade 3, 4) Inability to obtain informed consent
Target sample size	84

Research contact person
Name of lead principal investigator	Masayuki Kitano
Organization	Kinki University Faculty of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	377-2 Ohno-higashi, Osaka-sayama, Osaka, JAPAN
TEL	072-366-0221
Email	m-kitano@med.kindai.ac.jp

Public contact
Name of contact person	Masayuki Kitano
Organization	Kinki University Faculty of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	377-2 Ohno-higashi, Osaka-sayama, Osaka, JAPAN
TEL	072-366-0221
Homepage URL
Email	m-kitano@med.kindai.ac.jp

Sponsor
Institute	Department of Gastroenterology and Hepatology, Kinki University Faculty of Medicine
Institute
Department

Funding Source
Organization	The Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
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

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 30 Day
Anticipated trial start date	2015 Year 01 Month 26 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	Published
URL releasing results
Results
Other related information	In consequtive patients with pancreatobiliary tumors acompanied by lymphadenopathy, contrast-enhanced harmonic EUS, conventional EUS and color Dopller EUS are perfrmed. Diagnostic abilities to identify lymph node metastases for all modalities are evaluated and compared.

Management information
Registered date	2015 Year 01 Month 25 Day
Last modified on	2017 Year 02 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018951