UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052755 |
|---|---|
| Receipt number | R000060199 |
| Scientific Title | Short and long-term outcome of patients undergoing pancreaticoduodenectomy - a single institute prospective cohort study |
| Date of disclosure of the study information | 2023/12/01 |
| Last modified on | 2023/11/12 14:46:56 |
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Basic information
Public title
Short and long-term outcome of patients undergoing pancreaticoduodenectomy - a single institute prospective cohort study
Acronym
Postoperative outcome following PD
Scientific Title
Short and long-term outcome of patients undergoing pancreaticoduodenectomy - a single institute prospective cohort study
Scientific Title:Acronym
Short and long-term outcome of patients undergoing pancreaticoduodenectomy - a single institute prospective cohort study
Region
| Japan |
Condition
Condition
Peri-ampullar tumor
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to evaluate short and mid-term outcome of patients who would undergo pancreaticoduodenectomy (PD) at our institution.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
1) Proportion of postoperative complication
2) Proportion of body weight loss at 1 year after PD
3) Psoas muscle mass and CT density at 1 year after PD
4) Grip strength at 1 year after PD
Key secondary outcomes
1) Pancreatic exocrine function at 1 year after PD
2) Pancreatic endocrine function at1 year after PD
3) Development of fatty liver at 1 year after PD
4) Nutritional status at 1 year after PD
5) A diameter of remnant pancreatic duct and pancreatic parenchyma at 1 year after PD
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients who are planned to undergo PD in our institution
Key exclusion criteria
A case of emergent surgery
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Narita |
Organization
Kobe City Medical Center General Hospital
Division name
Department of Surgery
Zip code
6500047
Address
2-1-1, Minatojima-minamimachi, Chuo-ku, Kobe-city, Hyogo, 650-0047, Japan
TEL
075-302-4321
narinari@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Masato |
| Middle name | |
| Last name | Narita |
Organization
Kobe City Medical Center General Hospital
Division name
Department of Surgery
Zip code
6500047
Address
2-1-1, Minatojima-minamimachi, Chuo-ku, Kobe-city, Hyogo, 650-0047, Japan
TEL
0783024321
Homepage URL
narinari@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kobe City Medical Center General Hospital
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe city hospital organization certified review board
Address
2-1-1, Minatojima-minamimachi, Chuo-ku, Kobe-city, Hyogo, 650-0047, Japan
Tel
0783024321
narinari@kuhp.kyoto-u.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 11 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2023 | Year | 11 | Month | 10 | Day |
Last modified on
| 2023 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060199
| 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 |
