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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000047705
Receipt No. R000054388
Scientific Title EUS-guided hepaticogastrostomy in preoperative patients of pancreaticoduodenectomy
Date of disclosure of the study information 2022/05/10
Last modified on 2022/05/18

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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