UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024079 |
|---|---|
| Receipt number | R000027720 |
| Scientific Title | The study of left-sided portal hypertention after pancreaticoduodenectomy with combined resection of portal vein for pancreatic cancer |
| Date of disclosure of the study information | 2016/10/01 |
| Last modified on | 2021/03/21 23:11:26 |
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Basic information
Public title
The study of left-sided portal hypertention after pancreaticoduodenectomy with combined resection of portal vein for pancreatic cancer
Acronym
The study of left-sided portal hypertention after pancreaticoduodenectomy with combined resection of portal vein
Scientific Title
The study of left-sided portal hypertention after pancreaticoduodenectomy with combined resection of portal vein for pancreatic cancer
Scientific Title:Acronym
The study of left-sided portal hypertention after pancreaticoduodenectomy with combined resection of portal vein
Region
| Japan |
Condition
Condition
pancreatic head cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery | Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To identify the incidence and impact of left-sided portal hypertention after PD for pancreatic cancer, which have yet to be elucidated.
Basic objectives2
Others
Basic objectives -Others
Even in the high volume centers, the method to prevent the left-sided portal hypertention is still not standardized. Therefore, we evaluate the best procedure for its prevention using multi-center questionaries.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The incidence of left-sided portal hypertention according to the various procedures.
To identify it, we evaluate the incidence of gastrointestinal bleedings from the varices, platelets counts and spleen volume on POD 6 and 12 months
Key secondary outcomes
Analysis if various risk factors causing the left-sided portal hypertention after pancreaticduodenectomy
Base
Study type
Others,meta-analysis etc
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
1) Cases in which PD with PV resection were conducted.
2) Patients whose CT scan and Lab data were available on POM 6 and 12.
Key exclusion criteria
The patients of whom the criteria above mentioned were not satisfied.
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Shugo |
| Middle name | |
| Last name | Mizuno |
Organization
Mie university
Division name
Hepatobiliary pancreatic and transplant surgery
Zip code
514-8507
Address
2-174 Edobashi Tsu Mie, Japan ZIP:514-8507
TEL
0592321111
isaji-s@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Shugo |
| Middle name | |
| Last name | Mizuno |
Organization
Mie university
Division name
Hepatobiliary pancreatic and transplant surgery
Zip code
514-8507
Address
2-174 Edobashi Tsu Mie, Japan ZIP:514-8507
TEL
0592321111
Homepage URL
mizunos@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Hepatobiliary pancreatic and transplant surgery, Mie university
Institute
Department
Personal name
Funding Source
Organization
Japanese society of hepatobiliary pancreatic surgery
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
Mie University Graduate School of Medicine
Address
2-174Tsu Edobashi
Tel
0592321111
katohiroyuki510719@gmail.com
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
| 2016 | Year | 10 | 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
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We distributed the the first questionaries to the A ranked hospitals authorized by the Japanese society of hepatobiliary pancreatic surgery and selected the institutions in which PD with PV resection were carried out at least 10 cases from 2005.1 to 2014.12.
Management information
Registered date
| 2016 | Year | 09 | Month | 16 | Day |
Last modified on
| 2021 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027720
| 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 |
