UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003612 |
|---|---|
| Receipt number | R000004378 |
| Scientific Title | Pancreaticogastrostomy after distal pancreatectomy in patients with soft pancreas. |
| Date of disclosure of the study information | 2010/05/17 |
| Last modified on | 2012/11/13 09:16:16 |
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Basic information
Public title
Pancreaticogastrostomy after distal pancreatectomy in patients with soft pancreas.
Acronym
Pancreaticogastrostomy after distal pancreatectomy
Scientific Title
Pancreaticogastrostomy after distal pancreatectomy in patients with soft pancreas.
Scientific Title:Acronym
Pancreaticogastrostomy after distal pancreatectomy
Region
| Japan |
Condition
Condition
Patients with soft pancreas who undergo distal pancreatectomy
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reduce the frequency of pancreas-related complications
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the frequency of pancreas-related complications
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Pancreaticogastrostomy after distal pancreatectomy
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with soft pancreas who have the planned distal pancreatectomy
Key exclusion criteria
1) younger than 20 years old or older than 90 years old.
2) Patients with febrile
3) No written informed consent of the patients
4) Pregnancy or insufficient contraception
5) HIV infection
6) Doubtful understanding or contractual capacity of the patient
7)Patients seems inadequate for this study by investigator(s)
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sohei SATOI MD |
Organization
Kansai Medical University Hospital
Division name
Department of Surgery
Zip code
Address
2-3-1 Shinmachi, Hirakata, Osaka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kansai Medical University Hospital
Division name
Department of Surgery
Zip code
Address
TEL
Homepage URL
satoi@hriakata.kmu.ac.jp
Sponsor or person
Institute
Department of Surgery, Kansai 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
| 2010 | Year | 05 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
| 2010 | Year | 05 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 13 | Day |
Last modified on
| 2012 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004378
