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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030511
Receipt No. R000034831
Scientific Title A safety and efficacy of the cutting an ampulla of vater in ERCP
Date of disclosure of the study information 2017/12/21
Last modified on 2017/12/21

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Basic information
Public title A safety and efficacy of the cutting an ampulla of vater in ERCP
Acronym H-cut study
Scientific Title A safety and efficacy of the cutting an ampulla of vater in ERCP
Scientific Title:Acronym H-cut study
Region
Japan

Condition
Condition Biliary deseases
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 A safety and efficacy of the cutting an ampulla of vater in ERCP
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Adverese events rate
Early:Post ERCP pancreatitis, bleeding,perforation, et al.
Late:Stenosis of the papilla, pancreatitis, cholangitis, cholecystitis
Key secondary outcomes Efficacy
Success rate of bilialy cannulation
Total procedure time

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 Cutting an ampulla of vater
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. over 20 years of age
2. Patients who need biliary cannulation in ERCP for biliary disease

Key exclusion criteria 1. Not naiive papilla
2. Patients who need ERP for pancreatic desease
3. Patients considered ineligible for this study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo Hara
Organization Aichi Cancer Center Hospital
Division name Gastroenterology
Zip code
Address 1-1, kanokoden, chikusa-ku,Nagoya
TEL 052-762-611
Email khara@aichi-cc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinpei Matsumoto
Organization Aichi Cancer Center Hospital
Division name Gastroenterology
Zip code
Address 1-1, kanokoden, chikusa-ku,Nagoya
TEL 052-762-611
Homepage URL
Email smatsumoto@aichi-cc.jp

Sponsor
Institute Aichi Cancer Center Hospital
Institute
Department

Funding Source
Organization Aichi Cancer Center Hospital
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
Address
Tel
Email

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 愛知県がんセンター中央病院

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 21 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
2017 Year 10 Month 19 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 21 Day
Last modified on
2017 Year 12 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034831

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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