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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025727
Receipt No. R000029598
Scientific Title Effect of endoscopic transpapillary biliary drainage with/without endoscopic sphincterotomy on post-endoscopic retrograde cholangiopancreatography pancreatitis in patients with biliary stricture
Date of disclosure of the study information 2017/01/18
Last modified on 2019/02/14

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Basic information
Public title Effect of endoscopic transpapillary biliary drainage with/without endoscopic sphincterotomy on post-endoscopic retrograde cholangiopancreatography pancreatitis in patients with biliary stricture
Acronym E-BEST
Scientific Title Effect of endoscopic transpapillary biliary drainage with/without endoscopic sphincterotomy on post-endoscopic retrograde cholangiopancreatography pancreatitis in patients with biliary stricture
Scientific Title:Acronym E-BEST
Region
Japan

Condition
Condition Biliary stricture
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the non-inferiority of biliary drainage without endoscopic sphincterotomy (ES) compared to with ES in point of the incidence of post endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence of post ERCP pancreatitis after biliary stenting (plastic stent:PS or endoscopic naso-biliary drainage:NB) for naive major duodenal papilla.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Non-adding endoscopic sphincterotomy (non-ES)
Interventions/Control_2 Adding endoscopic sphincterotomy (ES)
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.Patients with biliary stricture confirmed by images, need for drainage.
2.Patients with biliary stricture need for placement of PS or NB as initial transpapillary biliary drainage.
3.Patients who are 20 years of age or older
4.Patients with informed consent
Key exclusion criteria 1.Patients with history of ERCP
2.Patients with history of gastrointestinal tract reconstruction
3.Patients with symptoms of acute pancreatitis
4.Impossible to reach to major duodenal papilla by duodenal endoscope
5.Patients with bleeding diathesis
6.Patients with severe cholangitis
7.ECOG-PS 4
8.Patients with pancreaticobiliary maljunction
9.Patients with severe cardiopulmonary disease
10.Expectant mother or lactating mother
11.Patients with tumor of papilla vater
12.Impossible to cannulate bile duct.
13.Patients that the physician in charge consider not suitable for inclusion
Target sample size 370

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaki Kuwatani
Organization Hokkaido University Hospital
Division name Division of Endoscopy/Department of Gastroenterology and Hepatology
Zip code
Address Kita 14,Nishi 5,Kita-ku,Sapporo, Hokkaido
TEL 011-716-1161
Email mkuwatan@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shin Kato
Organization Hokkaido University Hospital
Division name Department of Gastroenterology and Hepatology
Zip code
Address Kita 14,Nishi 5,Kita-ku,Sapporo, Hokkaido
TEL 011-716-1161
Homepage URL
Email katoshin@med.hokudai.ac.jp

Sponsor
Institute Department of Gastroenterology and Hepatology,Hokkaido University, Graduate school of medicine.
Institute
Department

Funding Source
Organization The Japanese Foundation for Research and Promotion of Endoscopy
Organization
Division
Category of Funding Organization Non profit foundation
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

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 18 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 Enrolling by invitation
Date of protocol fixation
2017 Year 01 Month 16 Day
Date of IRB
Anticipated trial start date
2017 Year 02 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 01 Month 18 Day
Last modified on
2019 Year 02 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029598

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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