UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044211 |
|---|---|
| Receipt number | R000050486 |
| Scientific Title | A multicenter observational study of a new metal stent with Anti-Reflux valve in patients with resectable or borderline resectable pancreatic cancer and obstructive jaundice during neoadjuvant treatment. |
| Date of disclosure of the study information | 2021/05/14 |
| Last modified on | 2022/05/16 19:29:48 |
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Basic information
Public title
A multicenter observational study of a new metal stent with Anti-Reflux valve in patients with resectable or borderline resectable pancreatic cancer and obstructive jaundice during neoadjuvant treatment.
Acronym
A multicenter observational study of a new metal stent with Anti-Reflux valve in patients with resectable or borderline resectable pancreatic cancer and obstructive jaundice during neoadjuvant treatment.
Scientific Title
A multicenter observational study of a new metal stent with Anti-Reflux valve in patients with resectable or borderline resectable pancreatic cancer and obstructive jaundice during neoadjuvant treatment.
Scientific Title:Acronym
A multicenter observational study of a new metal stent with Anti-Reflux valve in patients with resectable or borderline resectable pancreatic cancer and obstructive jaundice during neoadjuvant treatment.
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the patency and safety of a new coverd metal stent with Anti-Reflux valve during neoadjuvant chemotherapy for resectable and resectable borderline pancreatic cancer patients with biliary obstruction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stent patency rate
Key secondary outcomes
Cholangitis incidence
tecnical success rate
Adverse event
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Resectable or borderline resectable pancreatic ductal carcinoma case with bile duct stenosis (image diagnosis)
Cases planed NAC(R)T
Key exclusion criteria
Patients with performance status 4
Severe neurologic impairment or mental disorder
with severe other organ disorder
Pregnant or lactating women,
Cases in which endoscopic biliary drainage is impossible
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Honokuchi |
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Division name
Digestive and Lifestyle Diseases
Zip code
890-8520
Address
8-35-1 Sakuragaoka, Kagoshima
TEL
0992755326
m-hino@m.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Hinokuchi |
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Division name
Digestive and Lifestyle Diseases
Zip code
890-8520
Address
8-35-1 Sakuragaoka, Kagoshima
TEL
0992755326
Homepage URL
m-hino@m.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Address
8-35-1 Sakuragaoka, Kagoshima
Tel
099-275-6624
crmc@m2.kufm.kagoshima-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
| 2021 | Year | 05 | Month | 14 | 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
33
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
| 2019 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
n this study, a new coverd metal stent with Anti-Reflux valve was placed during preoperative adjuvant treatment for patient with resectable and resectable borderline pancreatic cancer and obstructive jaundice. We observe the stent occlusion rate until the operation.
Management information
Registered date
| 2021 | Year | 05 | Month | 14 | Day |
Last modified on
| 2022 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050486
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
