UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief title)	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	Masatsugu Shiba
Organization	osaka city university
Division name	Gastroenterology
Address	157asahimachi abenoku osaka city
TEL	06-6645-3811
Email	m2077735@med.osaka-cu.ac.jp

Public contact
Name of contact person	Masatsugu Shiba
Organization	osaka city university
Division name	Gastroenterology
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 12 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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