UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007278 |
|---|---|
| Receipt number | R000008584 |
| Scientific Title | Prospective study on pancreatic long internal stent tube in pancreaticoduodenectomy in patients with normal pancreas. |
| Date of disclosure of the study information | 2012/02/14 |
| Last modified on | 2014/02/13 09:20:30 |
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Basic information
Public title
Prospective study on pancreatic long internal stent tube in pancreaticoduodenectomy in patients with normal pancreas.
Acronym
pancreatic long internal stent tube in pancreaticoduodenectomy in patients with normal pancreas.
Scientific Title
Prospective study on pancreatic long internal stent tube in pancreaticoduodenectomy in patients with normal pancreas.
Scientific Title:Acronym
pancreatic long internal stent tube in pancreaticoduodenectomy in patients with normal pancreas.
Region
| Japan |
Condition
Condition
Patients with normal pancreas who have the planned pancreaticoduodenectomy
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify reduction of postoperative pancreatic fistula (POPF) rate in patients who underwent pancreatojejunostomy with long internal stenting of the pancreatic duct.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
POPF rate
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
A use of long internal stenting in pancreaticojejunostomy
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
Patients with normal pancreas who have the planned pancreaticoduodenectomy and who have the informed consent obtained
Key exclusion criteria
1) severe obesoty, BMI>30
2) patients who received steroid treatment
3) patients who have previous pancreatic surgery
4) patients whom main doctors judged inappropriate for study entry
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sohei SATOI MD |
Organization
Kansai Medical University
Division name
Department of Surgery
Zip code
Address
2-3-1, Shin-machi, Hirakata, Osaka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sohei SATOI MD |
Organization
Kansai Medical University
Division name
Department of Surgery
Zip code
Address
TEL
Homepage URL
satoi@hirakata.kmu.ac.jp
Sponsor or person
Institute
Deparment of Surgery
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Deparment of Surgery
Kansai 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
| 2012 | Year | 02 | Month | 14 | 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
Completed
Date of protocol fixation
| 2012 | Year | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 28 | Day |
Date trial data considered complete
| 2014 | Year | 01 | Month | 15 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 29 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 13 | Day |
Last modified on
| 2014 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008584
