UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026416 |
|---|---|
| Receipt number | R000030348 |
| Scientific Title | Advanced techniques have been developed to overcome difficult cannulation cases in endoscopic retrograde cholangiopancreatography (ERCP ). Pancreatic duct guidewire placement method (PGW) is performed in difficult cannulation cases; it is possible that it places patients at risk of post-ERCP pancreatitis (PEP). The mechanism of PEP is still unclear, but pancreatic duct pressure and injury of pancreatic duct are known causes of PEP. Therefore, we hypothesized a relationship between pancreatic duct diameter and PEP and predicted that PGW would increase the risk of PEP in patients with non-dilated pancreatic ducts. This study aimed to investigate whether PGW increased the risk of PEP in patients with pancreatic duct diameter <3 mm. |
| Date of disclosure of the study information | 2017/03/06 |
| Last modified on | 2017/03/06 13:45:09 |
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Basic information
Public title
Advanced techniques have been developed to overcome difficult cannulation cases in endoscopic retrograde cholangiopancreatography (ERCP ). Pancreatic duct guidewire placement method (PGW) is performed in difficult cannulation cases; it is possible that it places patients at risk of post-ERCP pancreatitis (PEP). The mechanism of PEP is still unclear, but pancreatic duct pressure and injury of pancreatic duct are known causes of PEP. Therefore, we hypothesized a relationship between pancreatic duct diameter and PEP and predicted that PGW would increase the risk of PEP in patients with non-dilated pancreatic ducts. This study aimed to investigate whether PGW increased the risk of PEP in patients with pancreatic duct diameter <3 mm.
Acronym
Risk of pancreatitis after pancreatic duct guidewire placement during endoscopic retrograde cholangiopancreatography.
Scientific Title
Advanced techniques have been developed to overcome difficult cannulation cases in endoscopic retrograde cholangiopancreatography (ERCP ). Pancreatic duct guidewire placement method (PGW) is performed in difficult cannulation cases; it is possible that it places patients at risk of post-ERCP pancreatitis (PEP). The mechanism of PEP is still unclear, but pancreatic duct pressure and injury of pancreatic duct are known causes of PEP. Therefore, we hypothesized a relationship between pancreatic duct diameter and PEP and predicted that PGW would increase the risk of PEP in patients with non-dilated pancreatic ducts. This study aimed to investigate whether PGW increased the risk of PEP in patients with pancreatic duct diameter <3 mm.
Scientific Title:Acronym
Risk of pancreatitis after pancreatic duct guidewire placement during endoscopic retrograde cholangiopancreatography.
Region
| Japan |
Condition
Condition
pancreatic and bile duct disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to investigate whether PGW increased the risk of PEP in patients with pancreatic duct diameter <3 mm.
Basic objectives2
Others
Basic objectives -Others
The mechanism of PEP is still unclear and considered to be related to various factors, including pancreatic duct pressure and damage of pancreatic duct, but no existing study focuses on the relationship between pancreatic duct diameter and PEP. We focused on pancreatic duct diameter and PGW to clarify the association between PGW and PEP; we hypothesized that when the pancreatic duct diameter is not dilated, PGW may increase the risk of PEP by further increasing the pressure in the pancreatic duct or by causing irritation or injury of the duct during ERCP. Therefore, we focused on patients with pancreatic duct diameter of less than 3 mm.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the rate of PEP
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria comprised a naive papilla, receipt of ERCP and a pancreatic duct diameter of less than 3 mm as determined by an imaging test received before ERCP.
Key exclusion criteria
Exclusion criteria comprised failed cannulation of the bile duct, pre-cannulation perforation, and pancreatic duct stenting.
Target sample size
332
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masatsugu Shiba |
Organization
osaka city university
Division name
Gastroenterology
Zip code
Address
157asahimachi abenoku osaka city
TEL
06-6645-3811
m2077735@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masatsugu Shiba |
Organization
osaka city university
Division name
Gastroenterology
Zip code
Address
157asahimachiabenoku osaka city
TEL
06-6645-3811
Homepage URL
m2077735@med.osaka-cu.ac.jp
Sponsor or person
Institute
osaka city university
Institute
Department
Personal name
Funding Source
Organization
none
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
Address
Tel
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
| 2017 | Year | 03 | Month | 06 | 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
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
| 2016 | Year | 12 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We carried out a retrospective review of all patients who had undergone ERCP at our department in Osaka City University hospital between January 2010 and December 2015.
Management information
Registered date
| 2017 | Year | 03 | Month | 06 | Day |
Last modified on
| 2017 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030348
