UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000016911
Receipt No. R000019624
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
Date of disclosure of the study information 2015/04/01
Last modified on 2018/04/09

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Tsuyoshi Mukai
Organization Gifu Municipal Hospital
Division name Department of Gastroenterology
Zip code
Address 7-1 Kashima-cho, Gifu, Japan
TEL 058-251-1101
Email tsuyomukai@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsuyoshi Mukai
Organization Gifu Municipal Hospital
Division name Department of Gastroenterology
Zip code
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
Address
Tel
Email

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 No longer recruiting
Date of protocol fixation
2015 Year 01 Month 26 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
2020 Year 06 Month 30 Day
Date of closure to data entry
2020 Year 06 Month 30 Day
Date trial data considered complete
2020 Year 06 Month 30 Day
Date analysis concluded
2020 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2015 Year 03 Month 25 Day
Last modified on
2018 Year 04 Month 09 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.