UMIN-CTR Clinical Trial

Basic information
Public title	Observational study of early precut for bile duct access in wire-guided cannulation.
Acronym	Evaluation of early precut algorithm
Scientific Title	Observational study of early precut for bile duct access in wire-guided cannulation.
Scientific Title:Acronym	Evaluation of early precut algorithm
Region	Japan

Condition
Condition	Biliary disease
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate early precutting at a 5-minute limit during wire-guided cannulation.
Basic objectives2	Others
Basic objectives -Others	To evaluate biliary accessibility and adverse events.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Biliary accessibility and predictors
Key secondary outcomes	Adverse events and risk factors

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	Naive papilla Patients who underwent biliary intervention
Key exclusion criteria	Not naive papilla Reconstructed anatomy Intervention for the pancreas Algorithm deviation Vater's tumor Direct precut Intervention through antegrade hepaticogastrostomy route
Target sample size	298

Research contact person
Name of lead principal investigator	1st name TESSHIN Middle name Last name BAN
Organization	University of Miyazaki
Division name	Department of Gastroenterology and Hepatology
Zip code	889-9602
Address	5200 Kihara, Kiyotake, Miyazaki, 889-9602
TEL	0985-85-9797
Email	venzosan0204@gmail.com

Public contact
Name of contact person	1st name TESSHIN Middle name Last name BAN
Organization	University of Miyazaki
Division name	Department of Gastroenterology and Hepatology
Zip code	889-9602
Address	5200 Kihara, Kiyotake, Miyazaki, 889-9602
TEL	0985-85-9797
Homepage URL
Email	venzosan0204@gmail.com

Sponsor
Institute	University of Miyazaki
Institute
Department

Funding Source
Organization	University of Miyazaki
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	University of Miyazaki Hospital, Clinical Research Support Center
Address	5200 Kihara, Kiyotake, Miyazaki, 889-9602
Tel	0985859797
Email	venzosan0204@gmail.com

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	2020 Year 05 Month 26 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	Completed
Date of protocol fixation	2018 Year 10 Month 17 Day
Date of IRB	2018 Year 10 Month 17 Day
Anticipated trial start date	2018 Year 10 Month 17 Day
Last follow-up date	2020 Year 05 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2020 Year 05 Month 25 Day
Last modified on	2021 Year 03 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046242