UMIN-CTR Clinical Trial

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 Masaki Middle name Last name Kuwatani
Organization	Hokkaido University Hospital
Division name	Division of Endoscopy/Department of Gastroenterology and Hepatology
Zip code	060-8648
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 Shin Middle name Last name Kato
Organization	Hokkaido University Hospital
Division name	Department of Gastroenterology and Hepatology
Zip code	060-8648
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	Hokkaido University Hospital Clinical Research Administration Center
Address	Kita 15,Nishi 7,Kita-ku,Sapporo,Hokkaido
Tel	011-706-7636
Email	crjimu@huhp.hokudai.ac.jp

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	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	370
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	Completed
Date of protocol fixation	2017 Year 01 Month 16 Day
Date of IRB	2017 Year 01 Month 16 Day
Anticipated trial start date	2017 Year 02 Month 01 Day
Last follow-up date	2022 Year 03 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	2017 Year 01 Month 18 Day
Last modified on	2021 Year 09 Month 22 Day

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