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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000047698
Receipt No. R000054379
Scientific Title Experience-related factors in the success of beginner endoscopic ultrasound-guided biliary drainage
Date of disclosure of the study information 2022/05/10
Last modified on 2022/05/10

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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

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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