UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022280 |
|---|---|
| Receipt number | R000025674 |
| Scientific Title | Validity of semicircumferencial dissection of superior mesenteric plexus in pancreatic head cancer based on the preoperative diagnosis of extrapancreatic plexus invasion by MDCT. |
| Date of disclosure of the study information | 2016/05/11 |
| Last modified on | 2016/05/11 18:20:46 |
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Basic information
Public title
Validity of semicircumferencial dissection of superior mesenteric plexus in pancreatic head cancer based on the preoperative diagnosis of extrapancreatic plexus invasion by MDCT.
Acronym
Validity of semicircumferencial dissection of superior mesenteric plexus in pancreatic head cancer based on the preoperative diagnosis of extrapancreatic plexus invasion by MDCT.
Scientific Title
Validity of semicircumferencial dissection of superior mesenteric plexus in pancreatic head cancer based on the preoperative diagnosis of extrapancreatic plexus invasion by MDCT.
Scientific Title:Acronym
Validity of semicircumferencial dissection of superior mesenteric plexus in pancreatic head cancer based on the preoperative diagnosis of extrapancreatic plexus invasion by MDCT.
Region
| Japan |
Condition
Condition
resectable or borderline resectable pancreatic head cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the validity of semicircimferencial dissection of superior mesenteric plexus in pancreatic head cancer based on the preoperative diagnosis of extrapancreatic plexus invasion by MDCT.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
R0 resection rate
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) resectable or borderline resectable pancreatic head cancer
2) Histologically proven pancreatic adenocarcinoma
3) more than 20 years old
4) ECOD performance status 0-1
5) written informed concent
Key exclusion criteria
1) the cases of taboo for MDCT
2) the cases with severe comorbidity
3) bad general condition
4) active double cancer
5) inappropriate cases
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihiko Tsuchida |
Organization
Tokyo Medical University
Division name
Gastrointestinal and Pediatric Surgery
Zip code
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
yatsukasahara@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichi Nagakawa |
Organization
Tokyo Medical University
Division name
Gastrointestinal and Pediatric Surgery
Zip code
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
Homepage URL
yatsukasahara@yahoo.co.jp
Sponsor or person
Institute
Department of Gastrointestinal and Pediatric Surgery, Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Gastrointestinal and Pediatric Surgery, Tokyo Medical University
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
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
| 2016 | Year | 05 | Month | 11 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 02 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2016 | Year | 05 | Month | 11 | Day |
Last modified on
| 2016 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025674
