UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016827 |
|---|---|
| Receipt number | R000019457 |
| Scientific Title | Concomitant portal vein resection in pancreaticoduodenectomy: Does it benefit patients with pancreatic head cancer and portal vein invasion? |
| Date of disclosure of the study information | 2015/04/10 |
| Last modified on | 2019/02/14 12:14:13 |
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Basic information
Public title
Concomitant portal vein resection in pancreaticoduodenectomy: Does it benefit patients with pancreatic head cancer and portal vein invasion?
Acronym
Concomitant portal vein resection in pancreaticoduodenectomy
Scientific Title
Concomitant portal vein resection in pancreaticoduodenectomy: Does it benefit patients with pancreatic head cancer and portal vein invasion?
Scientific Title:Acronym
Concomitant portal vein resection in pancreaticoduodenectomy
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We aimed to identify prognostic factors for survival in patients who underwent pancreaticoduodenectomy including concomitant portal vein resection.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Survival benefit of portal vein resection
Key secondary outcomes
Morbidity, Mortality
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
Patiens with pancreas cancer who had done radical resection in Hokkaido Univ. Hospital department of surgery II during January 1999 to March 2009.
Key exclusion criteria
Cases with exploratory laparotomy
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takehiro Noji |
Organization
Hokkaodo University Graduate schoolof medicine
Division name
Gastroenterological Surgery II
Zip code
Address
Kita 15 Nishi 7, Kita-ku, Sapporo city
TEL
011-716-1161
drnoji@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takehiro Noji |
Organization
Hokkaodo University Graduate schoolof medicine
Division name
Gastroenterological Surgery II
Zip code
Address
Kita 15 Nishi 7, Kita-ku, Sapporo city
TEL
011-716-1161
Homepage URL
drnoji@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaodo University Graduate school of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hokkaodi University Graduate school of Medicine
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
Address
Tel
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
北海道大学病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2014 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
112 patients were included in this retrospective study.
Management information
Registered date
| 2015 | Year | 03 | Month | 17 | Day |
Last modified on
| 2019 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019457
