UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030872 |
|---|---|
| Receipt number | R000035246 |
| Scientific Title | The safety and usefulness of intraoperative pancreatic duct drainage for distal pancreatectomy |
| Date of disclosure of the study information | 2018/01/29 |
| Last modified on | 2023/07/12 08:58:23 |
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Basic information
Public title
The safety and usefulness of intraoperative pancreatic duct drainage for distal pancreatectomy
Acronym
The safety and usefulness of pancreatic duct drainage for distal pancreatectomy
Scientific Title
The safety and usefulness of intraoperative pancreatic duct drainage for distal pancreatectomy
Scientific Title:Acronym
The safety and usefulness of pancreatic duct drainage for distal pancreatectomy
Region
| Japan |
Condition
Condition
Pancreatic tumor
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To check the safety and usefulness of intraoperative pancreatic duct drainage for distal pancreatectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Percentage of postoperative pancreatic fistula
Key secondary outcomes
Percentage of postoperative pancreatitis
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Detainment a pancreatic duct drainage tube for 3 days after surgery
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
Performance status: 0 or 1
Key exclusion criteria
Chronic renal failure
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hiroya |
| Middle name | |
| Last name | Akabori |
Organization
Shiga University of Medical Science
Division name
Department of Comprehensive Surgery
Zip code
520-2192
Address
Gochi-cho, Higashi-Ohmi city, Shiga
TEL
0748-22-3030
hakabori@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Hiroya |
| Middle name | |
| Last name | Akabori |
Organization
Shiga University of Medical Science
Division name
Department of Comprehensive Surgery
Zip code
520-2192
Address
Gochi-cho, Higashi-Ohmi city, Shiga
TEL
0748-22-3030
Homepage URL
hakabori@belle.shiga-med.ac.jp
Sponsor or person
Institute
Department of Comprehensive Surgery, Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Higashi-Ohmi General Medical Center
Address
Gochi-cho, Higashi-Ohmi city, Shiga
Tel
0748-22-3030
hqcomsur@belle.shiga-med.ac.jp
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
独立行政法人 国立病院機構 東近江総合医療センター (滋賀県)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 29 | 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
| 2017 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 18 | Day |
Last modified on
| 2023 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035246
| Research Plan | |
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| 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 |
