UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016911 |
|---|---|
| Receipt number | 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 | 2020/09/26 13:24:56 |
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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
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
tsuyomukai@yahoo.co.jp
Sponsor or person
Institute
BORE Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019624
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