UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060443 |
|---|---|
| Receipt number | R000069153 |
| Scientific Title | LBPS vs SEMS |
| Date of disclosure of the study information | 2026/02/01 |
| Last modified on | 2026/01/22 16:34:19 |
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Basic information
Public title
Large bore plastic stents (11.5Fr) versus fully covered self-expandable metallic stents for the management of preoperative endoscopic biliary obstruction in pancreatic cancer: multicenter retrospective cohort study
Acronym
LBPS vs SEMS
Scientific Title
LBPS vs SEMS
Scientific Title:Acronym
LBPS vs SEMS
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Searching for the optimal stent for biliary drainage before pancreatic cancer surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of Patency Between 11.5Fr Large-Diameter Plastic Stents and Metallic Stents
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Pathologically proven pancreatic cancer classified as resectable or borderline resectable by computed tomography (CT) or magnetic resonance imaging (MRI) or endoscopic ultrasound-guided fine needle aspiration (or biopsy)(EUS-FNA,FNB)
(2) Underwent preoperative biliary drainage for obstructive jaundice due to pancreatic cancer using LBPS or 10-12mm FCSEMS
Key exclusion criteria
(1) Biliary drainage was obtained with percutaneous transhepatic biliary drainage (PTBD) or endoscopic ultrasound-guided biliary drainage (EUS-BD), except for the rendezvous technique
(2) Coexisting malignant biliary obstruction involving the hilar part of the biliary system (2 cm below the confluence)
(3) Biliary drainage at other centers
(4) previous history of surgical biliary reconstruction
(5) adverse events, such as hemorrhage or perforation, occurring before stent deployment
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Maruta |
| Middle name | |
| Last name | Akinori |
Organization
Gifu University Hospital
Division name
First Department of Internal Medicine
Zip code
501-1194
Address
1-1 Yanagido, Gifu 501-1194, Japan
TEL
058-230-6308
mrak5844@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Maruta |
| Middle name | |
| Last name | Akinori |
Organization
Gifu University Hospital
Division name
First Department of Internal Medicine
Zip code
501-1194
Address
1-1 Yanagido, Gifu 501-1194, Japan
TEL
058-230-6308
Homepage URL
mrak5844@yahoo.co.jp
Sponsor or person
Institute
Gifu University Hospital
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 University Graduate School of Medicine and Faculty of Medicine Research Support SectionGifu University Hospital
Address
1-1 Yanagido, Gifu 501-1194, Japan
Tel
058-230-6059
rinri@t.gifu-u.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
| 2026 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
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
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2026 | Year | 01 | Month | 22 | Day |
Last modified on
| 2026 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069153
