UMIN-CTR Clinical Trial

Basic information
Public title	A prospective randomized comparative trial of covered self-expandable metallic stents with 12mm and 10mm diameters for the distal biliary obstructions in unresectable malignancies
Acronym	A prospective RCT of covered SEMS with 12mm and 10mm diameters for the distal biliary obstructions in unresectable malignancies (BORE Study)
Scientific Title	A prospective randomized comparative trial of covered self-expandable metallic stents with 12mm and 10mm diameters for the distal biliary obstructions in unresectable malignancies
Scientific Title:Acronym	A prospective RCT of covered SEMS with 12mm and 10mm diameters for the distal biliary obstructions in unresectable malignancies (BORE Study)
Region	Japan

Condition
Condition	unresectable distal biliary malignancies
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To compare the efficacy and safety of covered metallic stent between 12mm and 10 mm diameters for unresectable distal malignant biliary obstructions.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Stent occlusion rate and dysfunction rate at 180 days after stent deployment
Key secondary outcomes	1) Stent patency duration 2) Time to recurrent biliary obstruction (TRBO) 3) Overall stent patency rate and function rate 4) Median survival time 5) Stent-related complication rate

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Covered biliary metallic stent with a 10-mm diameter
Interventions/Control_2	Covered biliary metallic stent with a 12-mm diameter
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	Patients 1) with unresectable malignant distal biliary obstruction (> 2 cm distal to the biliary hilum) 2) expected prognosis more than 2 months 3) 20 years old 4) Eastern Cooperative Oncology Group Performance Status (ECOG-PS) < grade 2 5) obtained written informed consent.
Key exclusion criteria	1) patients with massive ascites 2) patients with severe comorbidities in other organs 3) prior biliary SEMS placement 4) patients with surgically altered anatomy 5) difficulty to achieve biliary cannulation during endoscopic retrograde cholangiography 6) intestinal obstruction distal to the ampulla 7) patients with pregnancy 8) patients considered ineligible by attending physicians
Target sample size	74

Research contact person
Name of lead principal investigator	1st name Mukai Middle name Last name Tsuyoshi
Organization	Gifu Municipal Hospital
Division name	Department of Gastroenterology
Zip code	500-8513
Address	7-1 Kashima-cho, Gifu, Japan
TEL	058-251-1101
Email	tsuyomukai@yahoo.co.jp

Public contact
Name of contact person	1st name Mukai Middle name Last name Tsuyoshi
Organization	Gifu Municipal Hospital
Division name	Department of Gastroenterology
Zip code	500-8513
Address	7-1 Kashima-cho, Gifu, Japan
TEL	058-251-1101
Homepage URL	http://gmhosp.jp/about-index/rinrishinsa/rinrishinsa-02.html
Email	tsuyomukai@yahoo.co.jp

Sponsor
Institute	BORE Study Group
Institute
Department

Funding Source
Organization	None
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	Gifu Municipal Hospital
Address	7-1 Kashima-cho, Gifu, Japan
Tel	058-251-1101
Email	tsuyomukai@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

1) 岐阜市民病院　消化器内科 Department of Gastroenterology, Gifu Municipal Hospital, Gifu 2) 岐阜大学　第一内科 First Department of Internal Medicine, Gifu University Hospital, Gifu 3) 岐阜県総合医療センター　消化器内科 Department of Gastroenterology, Gifu Prefectural General Medical Center, Gifu 4) 岐北厚生病院　消化器内科 Department of Gastroenterology, Gihoku Kosei Hospital, Yamagata 5) 羽島市民病院　消化器内科 Department of Gastroenterology, Hashima Municipal Hospital, Hashima 6) 帝京大学附属溝口病院　消化器内科 Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kawasaki 7) 東京大学　消化器内科 Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo

Other administrative information
Date of disclosure of the study information	2015 Year 04 Month 01 Day

Related information
URL releasing protocol	http://gmhosp.jp/about-index/rinrishinsa/rinrishinsa-02.html
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	2015 Year 01 Month 26 Day
Date of IRB	2015 Year 01 Month 26 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date	2020 Year 09 Month 30 Day
Date of closure to data entry	2020 Year 09 Month 30 Day
Date trial data considered complete	2020 Year 09 Month 30 Day
Date analysis concluded	2020 Year 10 Month 21 Day

Other
Other related information

Management information
Registered date	2015 Year 03 Month 25 Day
Last modified on	2020 Year 09 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019624