UMIN-CTR Clinical Trial

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
Email	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
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	Chiba University
Address	1-8-1 Inohana, Chuo-ku Chiba, Japan
Tel	0432262269
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039353