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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035775
Receipt No. R000040737
Scientific Title Influence of low skeletal muscle mass on perioperative complications after pancreaticoduodenectomy
Date of disclosure of the study information 2019/02/05
Last modified on 2019/02/04

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Basic information
Public title Influence of low skeletal muscle mass on perioperative complications after pancreaticoduodenectomy
Acronym Low skeletal muscle mass and perioperative complications
Scientific Title Influence of low skeletal muscle mass on perioperative complications after pancreaticoduodenectomy
Scientific Title:Acronym Low skeletal muscle mass and perioperative complications
Region
Japan

Condition
Condition Low skeletal muscle mass
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine retrospectively the influence of low skeletal muscle mass on perioperative complications after pancreaticoduodenectomy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The rate of perioperative 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 300

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Katsunori Furukawa
Organization Chiba University
Division name Department of General Surgey
Zip code
Address 1-8-1 Inohana, Chuo-ku Chiba, Japan
TEL 043-226-2269
Email k-furukawa@umin.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Katsunori Furukawa
Organization Chiba University
Division name Department of General Surgey
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2019 Year 02 Month 05 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
2009 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 05 Month 01 Day
Last follow-up date
2016 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To examine retrospectively the influence of low skeletal muscle mass on perioperative complications after pancreaticoduodenectomy

Management information
Registered date
2019 Year 02 Month 04 Day
Last modified on
2019 Year 02 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040737

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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