UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004445 |
|---|---|
| Receipt number | R000005320 |
| Scientific Title | The value of externally drained pancreatic juice replacement after pancreatoduodenectomy. |
| Date of disclosure of the study information | 2010/10/26 |
| Last modified on | 2010/10/26 12:47:11 |
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Basic information
Public title
The value of externally drained pancreatic juice replacement after pancreatoduodenectomy.
Acronym
The value of externally drained pancreatic juice replacement.
Scientific Title
The value of externally drained pancreatic juice replacement after pancreatoduodenectomy.
Scientific Title:Acronym
The value of externally drained pancreatic juice replacement.
Region
| Japan |
Condition
Condition
Any patients who need to undergo pancreatoduodenectomy.
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether replacemnt of externally drained pancreatic juice following pancreatoduodenctomy is beneficial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurrence of postoperative complications including pancreatic fistula.
Postoperative hospital stay.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
replacement of externally drained pancreatic juice
Interventions/Control_2
no replacement of externally drained pancreatic juice
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients who need to undergo pancreatoduodenectomy.
Key exclusion criteria
Unresectable cases due to locally far advanced cancer or distant metastasis.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukihiro Yokoyama |
Organization
Nagoya University Graduate School of Medicine,
Division name
Division of Surgical Oncology, Department of Surgery
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
052-744-2222
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Nagoya University Graduate School of Medicine
Division name
Division of Surgical Oncology, Department of Surgery
Zip code
Address
TEL
Homepage URL
yyoko@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoyo University Graduate School of Medicine, Division of Surgical Oncology, Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
Nagoyo University Graduate School of Medicine, Division of Surgical Oncology, Department of Surgery
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 | 10 | Month | 26 | 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
| 2006 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 26 | Day |
Last modified on
| 2010 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005320
| 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 |
