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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034689
Receipt No. R000039353
Official scientific title of the study 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 2018/10/29

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Basic information
Official scientific title of the study The influence of sarcopenia on postoperative complications after pancreaticoduodenectomy: a prospective cohort study
Title of the study (Brief title) 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 Katsunori Furukawa
Organization Chiba University
Division name Department of General Surgey
Address 1-8-1 Inohana, Chuo-ku Chiba, Japan
TEL 043-226-2269
Email k-furukawa@umin.ac.jp

Public contact
Name of contact person Katsunori Furukawa
Organization Chiba University
Division name Department of General Surgey
Address 1-8-1 Inohana, Chuo-ku Chiba, Japan
TEL 043-226-2269
Homepage URL
Email k-furukawa@umin.ac.jp

Sponsor
Institute Chiba University
Department of General Surgey
Institute
Department

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)

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2015 Year 11 Month 25 Day
Anticipated trial start date
2016 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information To investigate prospectively the influence of sarcopenia on postoperative complications after pancreaticoduodenectomy

Management information
Registered date
2018 Year 10 Month 29 Day
Last modified on
2018 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039353

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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