UMIN-CTR Clinical Trial

Basic information
Public title	Retrospective study of biliary drainage for malignant distal biliary obstruction using fully-covered self-expandable metal stent with duckbill shaped anti-reflux valve
Acronym	Retrospective study of DMBO drainage using D-ARMS
Scientific Title	Retrospective study of biliary drainage for malignant distal biliary obstruction using fully-covered self-expandable metal stent with duckbill shaped anti-reflux valve
Scientific Title:Acronym	Retrospective study of DMBO drainage using D-ARMS
Region	Japan

Condition
Condition	Patients with malignant distal biliary obstruction using laser-cut fully-covered self-expandable metal stent with duckbill shaped anti-reflux valve
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To examine the feasibility and safety of biliary stenting using fully-covered self-expandable metal stent with duckbill shaped anti-reflux valve
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Technical success
Key secondary outcomes	Procedural time, Functional success, Adverse event rate, Time to recurrent biliary obstruction

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	1) Distal biliary obstruction which was confirmed with imaging studies 2) Pathological confirmation of malignancy 3) Presence of liver dysfuction, jaundice, or cholangitis due to cholestasis
Key exclusion criteria	1) Surgical altered anatomy with Billroth-II or Roux-en-Y reconstruction 2) Failure to approach the papilla of Vater 3) Absence of hilar biliary obstruction 4) Inappropriate patients to this study
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Kin Middle name Last name Toshifumi
Organization	Teine Keijinkai Hospital
Division name	Center for Gastroenterology
Zip code	006-8555
Address	1-40-1-12 Maeda, Teine-ku, Sapporo, Hokkaido
TEL	011-681-8111
Email	kin_toshifumi@yahoo.co.jp

Public contact
Name of contact person	1st name Kin Middle name Last name Toshifumi
Organization	Teine Keijinkai Hospital
Division name	Center for Gastroenterology
Zip code	006-8555
Address	1-40-1-12 Maeda, Teine-ku, Sapporo, Hokkaido, 006-8555 Japan
TEL	011-681-8111
Homepage URL
Email	kin_toshifumi@yahoo.co.jp

Sponsor
Institute	Center for Gastroenterology, Teine-Keijinkai Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Gastroenterology and Hepatology, Tokyo Medical University Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Teine Keijinkai Hospital
Address	1-40-1-12 Maeda, Teine-ku, Sapporo, Hokkaido
Tel	011-681-8111
Email	teine@keijinkai.or.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	手稲渓仁会病院(北海道) 東京医科大学(東京) 久留米大学(福岡)

Other administrative information
Date of disclosure of the study information	2020 Year 04 Month 14 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	30
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	2019 Year 07 Month 08 Day
Date of IRB	2020 Year 02 Month 28 Day
Anticipated trial start date	2020 Year 02 Month 28 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Technical success, Procedural time, Functional success, Adverse event rate, Time to recurrent biliary obstruction

Management information
Registered date	2020 Year 04 Month 14 Day
Last modified on	2021 Year 01 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045782