UMIN-CTR Clinical Trial

Basic information
Public title	The relationship between skeletal muscle measured by ultrasound and perioperative prognosis of patients with hepatobiliary pancreatic cancer
Acronym	The relationship between skeletal muscle measured by ultrasound and perioperative prognosis of patients with hepatobiliary pancreatic cancer
Scientific Title	The relationship between skeletal muscle measured by ultrasound and perioperative prognosis of patients with hepatobiliary pancreatic cancer
Scientific Title:Acronym	The relationship between skeletal muscle measured by ultrasound and perioperative prognosis of patients with hepatobiliary pancreatic cancer
Region	Japan

Condition
Condition	Hepatobiliary pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the perioperative prognostic value of skeletal muscle mass measured by ultrasound
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relationship between skeletal muscle mass measured by ultrasound and duration of postoeprative hospital stay
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Histologically or diagnostically confirmed hepatobiliary pancreatic cancer patients Patients aged 20 years or older at the time ofacquiring consent Patients with ECOG Performance status 0 or 1 Patients who gained written consent by their own free will with sufficient understanding of participation in this study
Key exclusion criteria	Patients who received surgical treatment within 4 weeks before registration Patients with serious postoperative complications Patients with defective diabetes mellitus, hypertension and infectious disease Pregnant women or patients who may be pregnant Patients with psychosis or psychiatric symptoms and judged to be difficult to participate in clinical trials Patients who the physician deems inappropriate for registration
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takahashi Michiro
Organization	Shizuoka General Hospital
Division name	Department of Gastroenterological surgery
Zip code
Address	4-27-1 Kita-Ando Aoi-ku Shizuoka
TEL	054-247-6111
Email	michiro-tky@umin.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Takahashi Michiro
Organization	Shizuoka General Hospital
Division name	Department of Gastroenterological surgery
Zip code
Address	4-27-1 Kita-Ando Aoi-ku Shizuoka
TEL	054-247-6111
Homepage URL
Email	michiro-tky@umin.ac.jp

Sponsor
Institute	Shizuoka General Hospital
Institute
Department

Funding Source
Organization	None
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	2017 Year 02 Month 15 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	Enrolling by invitation
Date of protocol fixation	2016 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date	2017 Year 02 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observational study

Management information
Registered date	2017 Year 02 Month 14 Day
Last modified on	2017 Year 02 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030019

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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