UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030473 |
|---|---|
| Receipt number | R000032249 |
| Scientific Title | Fully covered self-expandable metal stent with an anti-migration system versus plastic stent for distal biliary obstruction caused by borderline resectable pancreatic cancer: a prospective randomized study |
| Date of disclosure of the study information | 2017/12/20 |
| Last modified on | 2024/01/10 18:45:00 |
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Basic information
Public title
Fully covered self-expandable metal stent with an anti-migration system versus plastic stent for distal biliary obstruction caused by borderline resectable pancreatic cancer: a prospective randomized study
Acronym
FCMS versus PS for the borderline resctable pancreatic cancer
Scientific Title
Fully covered self-expandable metal stent with an anti-migration system versus plastic stent for distal biliary obstruction caused by borderline resectable pancreatic cancer: a prospective randomized study
Scientific Title:Acronym
FCMS versus PS for the borderline resctable pancreatic cancer
Region
| Japan |
Condition
Condition
borderline resectable pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of randomized study was to assess the advantage of plastic stent vs. covered SEMS with an anti-migration system in term of rate of reintervention and postoperative complication
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
stent dysfunction
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervetions is to place a full covered self-expanable metal stent with anti-migration system to resectable borderline pancreatic cancer with bile duct obstruction
Interventions/Control_2
Control is to place a plastic stent to resectable borderline pancreatic cancer with bile duct obstruction
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
graphically diagnosed borderline resectable pancreatic cancer
malignant distal biliary obstruction
schedueled for neo adjvant chemotherapy
Key exclusion criteria
the anterior intestinal stricture of the nipple
sever dysfunction in other organs
difficult of endoscopic approach
hilar biliary obstruction
with distant metastasis
without pathological diagnosisa
a doctor judged inappropriate as a study
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Kitano |
Organization
wakayama medical university
Division name
Second Department of Internal Medicine
Zip code
6410012
Address
811-1 Kimiidera wakayama city wakayama
TEL
073-447-2300
kitano@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Tamura |
| Middle name | |
| Last name | Takashi |
Organization
wakayama medical university
Division name
Second Department of Internal Medicine
Zip code
6410012
Address
811-1 Kimiidera wakayama city wakayama
TEL
073-447-2300
Homepage URL
ttakashi28@gmail.com
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Rearch Reveiw Commitee of Wakayama Medical University
Address
811-1 Kimidera Wakayama-shi
Tel
0734410714
wa-riniri@wakayama-med.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 | 12 | Month | 20 | 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
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2020 | Year | 06 | 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 | 12 | Month | 19 | Day |
Last modified on
| 2024 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032249
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/07/02 | NAC 研究計画書 1.3版.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
