UMIN-CTR Clinical Trial

Basic information
Public title	Experience-related factors in the success of beginner endoscopic ultrasound-guided biliary drainage
Acronym	Experience-related factors in the success of EUS-BD
Scientific Title	Experience-related factors in the success of beginner endoscopic ultrasound-guided biliary drainage
Scientific Title:Acronym	Experience-related factors in the success of EUS-BD
Region	Japan

Condition
Condition	Malignant/Benign biliary stenosis, obstruction
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Analysis of experience-related factors in the success of beginner procedure
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Extract of experience-related factors in the success of beginner procedure
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	Patients undergoing EUS-BD with transmural stenting as an alternative treatment for ERCP due to malignant luminal obstruction, surgically altered anatomy, ERCP failure, and insufficient first drainage by ERCP. Patients undergoing EUS-BD using a self-expandable metal stent (SEMS), and/or dedicated plastic stent for EUS-BD
Key exclusion criteria	Patients undergoing EUS-guided rendezvous procedures.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Ryota Middle name Last name Sagami
Organization	Oita San-ai Medical Center
Division name	Department of Gastroenterology
Zip code	8701151
Address	1213 Oaza Ichi, Oita, Oita
TEL	097-541-1311
Email	sagami1985@yahoo.co.jp

Public contact
Name of contact person	1st name Ryota Middle name Last name Sagami
Organization	Oita San-ai Medical Center
Division name	Department of Gastroenterology
Zip code	8701151
Address	1213 Oaza Ichi, Oita, Oita
TEL	097-541-1311
Homepage URL
Email	sagami1985@yahoo.co.jp

Sponsor
Institute	Oita San-ai Medical Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Gastroenterology, Faculty of Medicine, Oita University Department of Gastroenterology, Nankai Medical Center, Department of Gastroenterology, Shin Beppu Hospital Department of Gastroenterology, Oita Medical Center Department of Gastroenterology, Oita City Medical Association Almeida Memorial Hospital Department of Endoscopy, Kishiwada Tokushukai Hospital Department of Gastroenterology, Saiseikai Kawaguchi General Hospital Department of Computational Brain Imaging, ATR Neural Information Analysis Laboratories
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Oita San-ai Medical Center
Address	1213 Oaza Ichi, Oita, Oita
Tel	097-541-1311
Email	sagami1985@yahoo.co.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	2022 Year 05 Month 10 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	Open public recruiting
Date of protocol fixation	2021 Year 06 Month 01 Day
Date of IRB	2021 Year 07 Month 08 Day
Anticipated trial start date	2021 Year 06 Month 01 Day
Last follow-up date	2022 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Retrospective study

Management information
Registered date	2022 Year 05 Month 10 Day
Last modified on	2022 Year 05 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054379