UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034689 |
|---|---|
| Receipt number | R000039353 |
| Scientific Title | The influence of sarcopenia on postoperative complications after pancreaticoduodenectomy: a prospective cohort study |
| Date of disclosure of the study information | 2018/12/01 |
| Last modified on | 2021/05/05 11:30:56 |
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Basic information
Public title
The influence of sarcopenia on postoperative complications after pancreaticoduodenectomy: a prospective cohort study
Acronym
The influence of sarcopenia on postoperative complications after pancreaticoduodenectomy
Scientific Title
The influence of sarcopenia on postoperative complications after pancreaticoduodenectomy: a prospective cohort study
Scientific Title:Acronym
The influence of sarcopenia on postoperative complications after pancreaticoduodenectomy
Region
| Japan |
Condition
Condition
pancreaticoduodenectomy
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate prospectively the influence of sarcopenia on postoperative complications after pancreaticoduodenectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of postoperative complications
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients undergoing pancreaticoduodenectomy
Key exclusion criteria
preoperative chemotherapy
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Katsunori |
| Middle name | |
| Last name | Furukawa |
Organization
Chiba University
Division name
Department of General Surgey
Zip code
260-0856
Address
1-8-1 Inohana, Chuo-ku Chiba, Japan
TEL
043-226-2269
k-furukawa@umin.ac.jp
Public contact
Name of contact person
| 1st name | Katsunori |
| Middle name | |
| Last name | Furukawa |
Organization
Chiba University
Division name
Department of General Surgey
Zip code
260-0856
Address
1-8-1 Inohana, Chuo-ku Chiba, Japan
TEL
043-226-2269
Homepage URL
k-furukawa@umin.ac.jp
Sponsor or person
Institute
Chiba University
Department of General Surgey
Institute
Department
Personal name
Funding Source
Organization
non
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
Chiba University
Address
1-8-1 Inohana, Chuo-ku Chiba, Japan
Tel
0432262269
igaku-kouhou@chiba-u.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
| 2018 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
https://doi.org/10.1016/j.clnu.2020.04.032
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.clnu.2020.04.032
Number of participants that the trial has enrolled
298
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 01 | Month | 01 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate prospectively the influence of sarcopenia on postoperative complications and survival rate after pancreaticoduodenectomy
Management information
Registered date
| 2018 | Year | 10 | Month | 29 | Day |
Last modified on
| 2021 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039353
| 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 |
