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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026416
Receipt No. 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

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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
Email 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
Email m2077735@med.osaka-cu.ac.jp

Sponsor
Institute osaka city university
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030348

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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