UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024820 |
|---|---|
| Receipt number | R000028564 |
| Scientific Title | Adverse events associated with ERCP for biliary diseases; a prospective multicenter observational study. |
| Date of disclosure of the study information | 2016/11/24 |
| Last modified on | 2022/11/20 17:38:42 |
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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
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
s-yazumi@kitano-hp.or.jp
Sponsor or person
Institute
Bilio-Pancreatic Stenting study group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028564
