UMIN-CTR Clinical Trial

Basic information
Public title	EUS-guided hepaticogastrostomy in preoperative patients of pancreaticoduodenectomy
Acronym	Preoperative EUS-HGS in patients of PD
Scientific Title	EUS-guided hepaticogastrostomy in preoperative patients of pancreaticoduodenectomy
Scientific Title:Acronym	Preoperative EUS-HGS in patients of PD
Region	Japan

Condition
Condition	Preoperative patients of pancreatoduodenectomy
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy of primary EUS-HGS in preoperative patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety
Key secondary outcomes	Bile juice cytology during EUS-HGS Clinical success rate of EUS-HGS

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	Treatment
Type of intervention	Maneuver
Interventions/Control_1	EUS-HGS
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	1) Cases requiring biliary drainage for jaundice, hepatic dysfunction, and acute cholangitis due to extrahepatic bile duct stenosis. 2) Cases in which the age at the time of obtaining consent is 20 years or older. 3) Cases for which informed consent has been obtained from the patient.
Key exclusion criteria	1) Bile duct cancer 2) Biliary drainage has already been performed by transpapillary or percutaneous 3) DIC 4) Cases that the physician decides inappropriate for this study
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Kazuo Middle name Last name Hara
Organization	Aichi Cancer Center
Division name	Gastroenterology
Zip code	464-8681
Address	1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, Japan
TEL	0527626111
Email	khara@aichi-cc.jp

Public contact
Name of contact person	1st name Nozomi Middle name Last name Okuno
Organization	Aichi Cancer Center
Division name	Gastroenterology
Zip code	464-8681
Address	1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, Japan
TEL	052-762-6111
Homepage URL
Email	nokuno@aichi-cc.jp

Sponsor
Institute	Aichi Cancer Center
Institute
Department

Funding Source
Organization	Aichi Cancer Center
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	Aichi Cancer Center
Address	1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, Japan
Tel	0527626111
Email	irb-jimu@aichi-cc.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	2021-0-208
Org. issuing International ID_1	Aichi Cancer Center
Study ID_2	IR031163
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 05 Month 10 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	Open public recruiting
Date of protocol fixation	2022 Year 05 Month 10 Day
Date of IRB	2022 Year 05 Month 10 Day
Anticipated trial start date	2022 Year 05 Month 10 Day
Last follow-up date	2028 Year 05 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	2022 Year 05 Month 10 Day
Last modified on	2022 Year 05 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054388