UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061556 |
|---|---|
| Receipt number | R000070432 |
| Scientific Title | Analysis of risk factors for PEP |
| Date of disclosure of the study information | 2026/05/13 |
| Last modified on | 2026/05/13 16:43:29 |
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Basic information
Public title
Preventive effect of prophylactic pancreatic duct stenting with endoscopic sphincterotomy for post-ERCP pancreatitis in PGW-assisted bile duct canulation
Acronym
Analysis of risk factors for PEP
Scientific Title
Analysis of risk factors for PEP
Scientific Title:Acronym
Analysis of risk factors for PEP
Region
| Japan |
Condition
Condition
Biliary tract disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Preventive effect of prophylactic pancreatic duct stenting with endoscopic sphincterotomy for post-ERCP pancreatitis in PGW-assisted bile duct canulation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Risk factors for 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with PGW-assisted biliary canulation
Key exclusion criteria
Patients with altered intestine after surgery
Target sample size
900
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Yamaguchi |
Organization
NHO Kure Medical Center and Chugoku Cancer Center
Division name
Division of Minimally Invasive Cancer Treatment
Zip code
737-0023
Address
Aoyamacho 3-1, Kure, Hiroshima , Japan
TEL
0823250142
yamaguchi.atsushi.uc@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Yamaguchi |
Organization
NHO Kure Medical Center and Chugoku Cancer Center
Division name
Division of Minimally Invasive Cancer Treatment
Zip code
737-0023
Address
Aoyamacho 3-1, Kure, Hiroshima
TEL
0823223111
Homepage URL
yamaguchiaiueo1@gmail.com
Sponsor or person
Institute
Division of Minimally Invasive Cancer Treatment, NHO Kure Medical Center and Chugoku Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Division of Minimally Invasive Cancer Treatment, NHO Kure Medical Center and Chugoku Cancer Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NHO Kure Medical Center and Chugoku Cancer Center
Address
Aoyamacho 3-1, Kure, Hiroshima
Tel
0823223111
yamaguchi.atsushi.uc@mail.hosp.go.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
| 2026 | Year | 05 | Month | 13 | 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
214
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
Main results already published
Date of protocol fixation
| 2025 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We analyzed the risk factors for PEP in 226 PGW-assisted cases, including 153 patients who also underwent EST.
Results: There were 22 PEP cases overall (2.4%), including 19 (8.4%) PGW-assisted and 3 (0.4%) non-PGW-assisted cases. In the multivariate analysis, parapapillary diverticulum was a risk factor for PEP , and EST plus PS was identified as a reduction factor.
Management information
Registered date
| 2026 | Year | 05 | Month | 13 | Day |
Last modified on
| 2026 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070432
