UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026220 |
|---|---|
| Receipt number | R000029996 |
| Scientific Title | Evaluation of efficiency of mesenteric approach during pancreaticoduodenectomy for pancreatic cancer |
| Date of disclosure of the study information | 2017/02/20 |
| Last modified on | 2017/08/22 11:49:45 |
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Basic information
Public title
Evaluation of efficiency of mesenteric approach during pancreaticoduodenectomy for pancreatic cancer
Acronym
Evaluation of efficiency of mesenteric approach during pancreaticoduodenectomy
Scientific Title
Evaluation of efficiency of mesenteric approach during pancreaticoduodenectomy for pancreatic cancer
Scientific Title:Acronym
Evaluation of efficiency of mesenteric approach during pancreaticoduodenectomy
Region
| Japan |
Condition
Condition
Patients with pancreatic ductal adenocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to evaluate of clinical benefits of mesenteric approach during pancreaticoduodenectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood loss volume, R0 rate
Key secondary outcomes
operative time, recurrence rate, overall survival, disease free survival
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
pancreatic cancer patients undergoing pancreaticoduodenectomy
Key exclusion criteria
patients without pathological diagnosis of pancreatic ductal adenocarcinoma
Target sample size
237
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiko Hirono |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
Address
811-1 Kimiidera, Wakayama, Japan
TEL
073-441-0613
seiko-h@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seiko Hirono |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
Address
811-1 Kimiidera, Wakayama, Japan
TEL
073-441-0613
Homepage URL
seiko-h@wakayama-med.ac.jp
Sponsor or person
Institute
Second Department of Surgery, Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Second Department of Surgery, Wakayama Medical University
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 | 02 | Month | 20 | 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
Mesenteric approach could reduce intraoperative blood loss volume in both resectable and borderline resectable (BR) PDAC during pancreaticoduodenectomy (PD). In resectable PDAC, mesenteric approach could increase R0 rate and improve the overall survival (OS), however, in BR PDAC, could not do them. Therefore, resectable PDAC has oncological benefits of mesenteric approach, however, only surgical method might not give the oncological benefit fo BR PDAC might.
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 | 01 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 12 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observable study
Evalustion for the efficiency of mesenteric approach for pancreatic cancer
Management information
Registered date
| 2017 | Year | 02 | Month | 20 | Day |
Last modified on
| 2017 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029996
