UMIN-CTR Clinical Trial

Basic information
Public title	The effect of endoscopic sphincterotomy in prevention of post-ERCP pancreatitis after metallic stent placement in patients with malignant distal biliary obstruction except pancreatic cancer; Multicenter observational study
Acronym	The effect of MS placement without ES for malignant distal biliary obstruction except pancreatic cancer on prevention of PEP
Scientific Title	The effect of endoscopic sphincterotomy in prevention of post-ERCP pancreatitis after metallic stent placement in patients with malignant distal biliary obstruction except pancreatic cancer; Multicenter observational study
Scientific Title:Acronym	The effect of MS placement without ES for malignant distal biliary obstruction except pancreatic cancer on prevention of PEP
Region	Japan

Condition
Condition	Malignant distal biliary stricture due to bile duct cancer, gall bladder cancer, cystic duct cancer, ampullary cancer and lymph node metastasis
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of non-adding endoscopic sphincterotomy prior to metalic stent placement in the patients with distal malignant biliary obstruction except pancreatic cancer in multicenter, retrospective setting.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of post-ERCP pancreatitis
Key secondary outcomes	1)Incidence of cholangitis, bleeding and perforation after ERCP 2)Serum amylase level before and after ERCP 3)Incidence of Stent dysfunction and Patency period of stent

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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. Patients with distal malignant biliary obstruction 2. Patients who underwent transpapillary metalic stent placement by means of ERCP 3. Patients who are 20 years of age or older
Key exclusion criteria	1. Former history of endoscopic sphinterotomy before metalic stent placement 2. Patients with pancreatic cancer 3. Patients that the physician in charge consider not suitable for inclusion
Target sample size	183

Research contact person
Last 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	0608638
Address	kita-ku, kita15, nishi7
TEL	0117161161
Email	mkuwatan@med.hokudai.ac.jp

Public contact
1st 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	0608638
Address	kita-ku, kita15, nishi7
TEL	0117161161
Homepage URL
Email	katoshin@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Hospital Department of Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization	Self funding
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	Hokkaido University Hospital IRB
Address	kita-ku, kita15, nishi7
Tel	0117161161
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	2019 Year 05 Month 13 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	183
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	No longer recruiting
Date of protocol fixation	2018 Year 12 Month 01 Day
Date of IRB	2019 Year 01 Month 10 Day
Anticipated trial start date	2019 Year 01 Month 10 Day
Last follow-up date	2024 Year 01 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2019 Year 05 Month 11 Day
Last modified on	2019 Year 05 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040818