UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003535 |
|---|---|
| Receipt number | R000004293 |
| Scientific Title | The change of complication ratio after Pancreotoduodenectomy according to a method of reconstruction. |
| Date of disclosure of the study information | 2010/04/26 |
| Last modified on | 2013/10/27 10:49:07 |
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Basic information
Public title
The change of complication ratio after Pancreotoduodenectomy according to a method of reconstruction.
Acronym
PD after reconstruction: R-Y vs B-II
Scientific Title
The change of complication ratio after Pancreotoduodenectomy according to a method of reconstruction.
Scientific Title:Acronym
PD after reconstruction: R-Y vs B-II
Region
| Japan | Asia(except Japan) | North America |
Condition
Condition
Patients with pancreatoduodenectomy
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Complication ratio after Pancreotoduodenectomy according to a method of reconstruction: R-Y vs B-II
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
reito of complication
Key secondary outcomes
recurrent rate
survival rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
R-Y reconstruction
Interventions/Control_2
B-II reconstruction
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
preoperative pancrea duct dilatation
Key exclusion criteria
patients with post gastrectomy
patients with hepatectomy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiichi Kubota |
Organization
Dokkyo Medical university
Division name
Second department of surgery
Zip code
Address
880 kitakobayashi, Mibu, Tochigi, Japan
TEL
0282-87-2158
mshimoda@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsugi Shimoda |
Organization
Dokkyo Medical university
Division name
Second department of surgery
Zip code
Address
880 kitakobayashi, Mibu, Tochigi, Japan
TEL
0282-87-2158
Homepage URL
mshimoda@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
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
獨協医科大学病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 26 | Day |
Related information
URL releasing protocol
http://www.dokkyomed.ac.jp/dep-m/surg2/index.html
Publication of results
Published
Result
URL related to results and publications
http://www.dokkyomed.ac.jp/dep-m/surg2/index.html
Number of participants that the trial has enrolled
Results
It is suggested that the incidence of DGE after SSPPD can be decreased by using B-II rather than R-Y reconstruction for gastrojejunostomy.
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
| 2007 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 04 | Month | 26 | Day |
Last modified on
| 2013 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004293
| 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 |
