UMIN-CTR Clinical Trial

Basic information
Public title	Adverse events associated with ERCP for biliary diseases; a prospective multicenter observational study.
Acronym	Adverse events associated with ERCP for biliary diseases.
Scientific Title	Adverse events associated with ERCP for biliary diseases; a prospective multicenter observational study.
Scientific Title:Acronym	Adverse events associated with ERCP for biliary diseases.
Region	Japan

Condition
Condition	Adverse events associated with ERCP
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To research clinical questions about adverse events associated with ERCP for biliary diseases.
Basic objectives2	Others
Basic objectives -Others	To detect risk factors. To develop a clinical prediction rule. To evaluate prophylactic procedures.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Incidence and severity of adverse events associated with ERCP.
Key secondary outcomes	1)Risk factors for post-ERCP pancreatitis. 2)Effectiveness of preventive procedures for post-ERCP pancreatitis.

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients who underwent transpapillary ERCP for biliary diseases. 2) Patients with intact papilla. 3) Patients without history of pancreatic surgery.
Key exclusion criteria	1) Patients with clinical evidence of acute pancreatitis at the time of the procedure. 2) Patients with altered gastrointestinal anatomy. e.g. Roux-en-Y reconstruction. 3) Patients whose ASA performance status is more than 3.
Target sample size	3000

Research contact person
Name of lead principal investigator	1st name Shujiro Middle name Last name Yazumi
Organization	The Tazuke Kofukai Medical Research Institute Kitano Hospital
Division name	Department of Gastroenterology and Hepatology
Zip code	530-8480
Address	2-4-20, Ohgimachi, Kita-ku, Osaka, Japan 530-8480
TEL	06-6312-1221
Email	s-yazumi@kitano-hp.or.jp

Public contact
Name of contact person	1st name Shujiro Middle name Last name Yazumi
Organization	The Tazuke Kofukai Medical Research Institute Kitano Hospital
Division name	Department of Gastroenterology and Hepatology
Zip code	530-8480
Address	2-4-20, Ohgimachi, Kita-ku, Osaka, Japan 530-8480
TEL	06-6312-1221
Homepage URL
Email	s-yazumi@kitano-hp.or.jp

Sponsor
Institute	Bilio-Pancreatic Stenting study group
Institute
Department

Funding Source
Organization	None
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	Institutional Review Board, Kitano Hospital
Address	2-4-20, Ohgimachi, Kita-ku, Osaka, Japan 530-8480
Tel	06-6312-1221
Email	rinshou@kitano-hp.or.jp

Secondary IDs
Secondary IDs	NO
Study ID_1	P16-11-006
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions

Institutions

愛仁会高槻病院（大阪府）、愛仁会千船病院（大阪府）、大阪医科大学附属病院（大阪府）、大阪市立総合医療センター（大阪府）、大阪赤十字病院（大阪府）、大阪府済生会中津病院（大阪府）、大阪府立成人病センター（大阪府）、北野病院（大阪府）、北播磨総合医療センター（兵庫県）、京都大学医学附属病院（京都府）、京都府立医科大学附属病院（京都府）、近畿大学医学部附属病院（大阪府）、神戸市立医療センター西市民病院（兵庫県）、神戸大学医学部附属病院（兵庫県）、市立豊中病院（大阪府）、天理よろづ相談所病院（奈良県）、奈良県立医科大学附属病院（奈良県）、日本赤十字社和歌山医療センター（和歌山県）、ベルランド総合病院（大阪府）、淀川キリスト教病院（大阪府）、和歌山県立医科大学附属病院（和歌山県）、岡山大学病院（岡山県）、JA尾道総合病院（広島県）、川崎医科大学附属総合医療センター（岡山県）、広島市立広島市民病院（広島県）、広島赤十字・原爆病院（広島県）、島根大学医学部附属病院（島根県）、鳥取赤十字病院（鳥取県）、鳥取大学医学部附属病院（鳥取県）、松江赤十字病院（島根県）、愛媛大学附属病院（愛媛県）、香川大学医学部附属病院（香川県）、四国がんセンター（愛媛県）、大分三愛メディカルセンター（大分県）、新別府病院（大分県）、福岡大学筑紫病院（福岡県）

Other administrative information
Date of disclosure of the study information	2016 Year 11 Month 24 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	3739
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	We are currently analyzing data.
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	Main results already published
Date of protocol fixation	2016 Year 11 Month 14 Day
Date of IRB	2016 Year 11 Month 22 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date	2018 Year 04 Month 30 Day
Date of closure to data entry	2018 Year 11 Month 30 Day
Date trial data considered complete	2019 Year 12 Month 02 Day
Date analysis concluded	2024 Year 03 Month 31 Day

Other

Other related information

1) Incidence and severity of adverse events associated with ERCP. 2) Relationship between pancreatic contrast injection/guidewire insertion for pancreatic duct and post-ERCP pancreatitis (PEP). 3) Relationship between difficult cannulation and PEP. 4) Relationship between precut/EST/EPBD/EPLBD and PEP. 5) Detection of risk factors for post-ERCP pancreatitis. 6) Development of clinical prediction rule for PEP. 7) Effectiveness of prophylactic pancreatic stenting. 8) Quality indicators for biliary ERCP 9) Relationship between shape of papilla and biliary cannulation and adverse events

Management information
Registered date	2016 Year 11 Month 14 Day
Last modified on	2022 Year 11 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028564