UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038243 |
|---|---|
| Receipt number | R000043557 |
| Scientific Title | Prediction rule for post-ERCP pancreatitis |
| Date of disclosure of the study information | 2019/10/14 |
| Last modified on | 2021/10/09 19:34:34 |
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Basic information
Public title
Prediction rule for post-ERCP pancreatitis
Acronym
Prediction rule for post-ERCP pancreatitis
Scientific Title
Prediction rule for post-ERCP pancreatitis
Scientific Title:Acronym
Prediction rule for post-ERCP pancreatitis
Region
| Japan |
Condition
Condition
post-ERCP pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The Aim of this study is to develop a practical prediction rule for post-ERCP pancreatitis.
Basic objectives2
Others
Basic objectives -Others
prediction rule
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
post-ERCP pancreatitis
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inclusion criterion was patients who underwent transpapillary ERCP.
Key exclusion criteria
Exclusion criteria were under 18 years old, patients with clinical evidence of acute pancreatitis at the time of the procedure, and patients with altered gastrointestinal anatomy. e.g. Roux-en-Y reconstruction.
Target sample size
2500
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Fujita |
Organization
Yodogawa Christian Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
533-0024
Address
1-7-50, Kunijima, Higashiyodogawa-ku, Osaka, Japan
TEL
06-6322-2250
koichifujitarm@gmail.com
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Fujita |
Organization
Yodogawa Christian Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
533-0024
Address
1-7-50, Kunijima, Higashiyodogawa-ku, Osaka, Japan
TEL
06-6322-2250
Homepage URL
koichifujitarm@gmail.com
Sponsor or person
Institute
Yodogawa Christian Hospital
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, Yodogawa Christian Hospital
Address
1-7-50, Kunijima, Higashiyodogawa-ku, Osaka, Japan
Tel
06-6322-2250
rinri@ych.or.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
淀川キリスト教病院(大阪）
公益法人田附興風会医学研究所北野病院（大阪）
京都大学医学部付属病院（京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 14 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/full/10.1002/jgh3.12634
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/full/10.1002/jgh3.12634
Number of participants that the trial has enrolled
2719
Results
PEP developed in 133 cases (4.9%).
A scoring system was constructed
using these seven clinical variables. The areas under the receiver-operating characteristic
curve of this model were 0.799 in the training set and 0.791 in the validation set.
In the high-risk group at a score of 3 or higher, the incidence of PEP was 13.4%, and
all severe/fatal cases were in the high-risk group.
Results date posted
| 2021 | Year | 10 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
In the patient cohort, 40%
were women, and the median age was 67.2 years. ERCP for biliary
diseases and that for pancreatic diseases were 73.2 and
26.8%, respectively.
Participant flow
During the study period, 2976
ERCPs were performed at the three participating hospitals.
Among these, 257 ERCPs were excluded for the following reasons:
patient age <18 years, 10; comorbid acute pancreatitis, 70;
altered gastrointestinal anatomy, 114; anastomosis or fistula, 32;
data missing, 19, and others, 12. Therefore, 2719 ERCPs were
included in the present study.
Adverse events
none.
Outcome measures
post-ERCP pancreatitis
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 08 | Month | 12 | Day |
Date of IRB
| 2012 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2012 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 05 | Month | 31 | Day |
Other
Other related information
Retrospective cohort study.
We retrospectively assembled databases of consecutive ERCP procedures performed at Kyoto university Hospital, Kitano Hospital, and Yodogawa Christian Hospital between April 2010 and September 2012.
Management information
Registered date
| 2019 | Year | 10 | Month | 08 | Day |
Last modified on
| 2021 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043557
