UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028732 |
|---|---|
| Receipt number | R000032881 |
| Scientific Title | Investigation of postoperative complications and survival time after distal pancreatectomy with celiac axis en-bloc resection for pancreatic carcinoma |
| Date of disclosure of the study information | 2017/08/18 |
| Last modified on | 2019/02/18 14:38:02 |
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Basic information
Public title
Investigation of postoperative complications and survival time after distal pancreatectomy with celiac axis en-bloc resection for pancreatic carcinoma
Acronym
Investigation of postoperative complications and survival time after distal pancreatectomy with celiac axis en-bloc resection for pancreatic carcinoma
Scientific Title
Investigation of postoperative complications and survival time after distal pancreatectomy with celiac axis en-bloc resection for pancreatic carcinoma
Scientific Title:Acronym
Investigation of postoperative complications and survival time after distal pancreatectomy with celiac axis en-bloc resection for pancreatic carcinoma
Region
| Japan |
Condition
Condition
Pancreatic carcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to verify the preventive procedure and survival impact of distal pancreatectomy with celiac axis en-bloc resection for pancreatic carcinoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of organ ischemia and survival time after distal pancreatectomy with celiac axis en-bloc resection
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients underwent distal pancreatectomy with celiac axis en-bloc resection at Wakayama Medical University from January 2005 to May 2017
Key exclusion criteria
Patients judged as inappropriate for this study by the research director
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken-ichi Okada |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
Address
Kimiidera 811-1, Wakayama City
TEL
073-441-0613
okada@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken-ichi Okada |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
Address
Kimiidera 811-1, Wakayama City
TEL
073-441-0613
Homepage URL
http://www.wakayama-med-2ndsurg.jp/
okada@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
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
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 18 | 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
| 2017 | Year | 07 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | 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
Observation items
Patients information: age, gender, clinical record, diagnosis
Operative information: operative method, postoperative complication
CT findings
Management information
Registered date
| 2017 | Year | 08 | Month | 18 | Day |
Last modified on
| 2019 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032881
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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