UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027239 |
|---|---|
| Receipt number | R000025608 |
| Scientific Title | Randomized controlled trial of covered metallic stent for malignant lower biliary stricture: Braded vs Laser-cut type |
| Date of disclosure of the study information | 2017/05/03 |
| Last modified on | 2026/05/10 09:55:06 |
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Basic information
Public title
Randomized controlled trial of covered metallic stent for malignant lower biliary stricture: Braded vs Laser-cut type
Acronym
RCT of covered SEMS for MBS: Braded vs Laser-cut type
Scientific Title
Randomized controlled trial of covered metallic stent for malignant lower biliary stricture: Braded vs Laser-cut type
Scientific Title:Acronym
RCT of covered SEMS for MBS: Braded vs Laser-cut type
Region
| Japan |
Condition
Condition
unresected malignancies causing lower or middle biliary stricture
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Many have reported the utility of endoscopic treatment using self-expanded metallic stent (SEMS) for lower or middle biliary stricture caused by malignancies.
There are two types in SEMS, Braded and Laser-cut type, and they have each different feature. In the present study, we will prospectively compare and estimate the clinical outcomes between the two types of SEMS.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
rate of stent dysfunction one year after stent intervention
Key secondary outcomes
safety, success rate, time of stent patency, overall time of survival
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
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention: Laser-cut type of SEMS
Interventions/Control_2
Control: Braded type of SEMS
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
1) Patients' age of more than 20 years-old.
2) Patients having lower or middle biliary stricture caused by unresectable malignancies
3) Patients having dilation of bile duct and cholangitis, obstructive jaundice or liver dysfunction.
4) Patients who are judged appropriate for endoscopic biliary stenting using metallic stent by chief (responsive) medical examiner.
5) Written informed consent is obtained from patient before the study.
Key exclusion criteria
1) Patients' age of less than 20 years-old.
2) Patients having resectable malignancies.
3) Written informed consent is not obtained from patient before the study.
4) Patients who are judged inappropriate by chief (responsive) medical examiner.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takamitsu |
| Middle name | |
| Last name | Sato |
Organization
Yokohama City University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan.
TEL
+81-45-787-2640
tkmtsato@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Takamitsu |
| Middle name | |
| Last name | Sato |
Organization
Yokohama City University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan.
TEL
+81-45-787-2640
Homepage URL
tkmtsato@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama city university Hospital
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Yokohama CIty University
Address
1-1-1 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan.
Tel
+81-45-370-7629
rinri@yokohama-cu.ac.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
| 2017 | Year | 05 | Month | 03 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000025608
Publication of results
Published
Result
URL related to results and publications
https://www.giejournal.org/article/S0016-5107(23)03133-4/abstract
Number of participants that the trial has enrolled
60
Results
The rates of RBO within 1 year were 44.4% and 17.2% in groups L and B, respectively (odds ratio, 2.57; 95% confidence interval [CI], 1.045-6.353). The median TRBO (220 days [95% CI, 56-272] vs 418 days [95% CI, 232-454]) was significantly longer in group B than in group L (log-rank test, P = .0118). The median overall survival (group L, 158 days; group B, 204 days) after stenting was not significantly different between groups (P = .8544).
Results date posted
| 2026 | Year | 05 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients diagnosed with unresectable DMBO were randomly assigned to groups L and B in a stratified block fashion, and outcomes were compared.
Participant flow
Patients diagnosed with unresectable DMBO were randomly assigned to groups L and B in a stratified block fashion, and outcomes were compared.
Adverse events
Early adverse events, which improved with conservative treatment, included pancreatitis (n = 4) in group L and pancreatitis (n = 3) and cholecystitis (n = 1) in group B (P = .913).
Outcome measures
The primary outcome was the rate of RBO within 1 year; secondary outcomes were adverse events, clinical success rate, time to RBO (TRBO), and overall survival.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 03 | Day |
Last modified on
| 2026 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025608
