UMIN-CTR Clinical Trial

Basic information
Public title	A new prognostic marker combining preoperative IBPS and handgrip strength in pancreatic head cancer undergoing pancreaticoduodenectomy
Acronym	A new prognostic marker in pancreatic head cancer undergoing pancreaticoduodenectomy
Scientific Title	A new prognostic marker combining preoperative IBPS and handgrip strength in pancreatic head cancer undergoing pancreaticoduodenectomy
Scientific Title:Acronym	A new prognostic marker in pancreatic head cancer undergoing pancreaticoduodenectomy
Region	Japan

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

Objectives
Narrative objectives1	To investigate whether the combination of grip strength and IBPS is a useful new preoperative prognostic factor for pancreatic head cancer undergoing pancreatoduodenectomy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Overall Survival
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 underwent pancreaticoduodenectomy for pancreatic head cancer
Key exclusion criteria	Patients whose preoperative grip strength was not measured
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Daisuke Middle name Last name Suzuki
Organization	Chiba University
Division name	Department of General Surgery
Zip code	2600856
Address	1-8-1 Inohana, Chuo-ku Chiba, Japan
TEL	043-222-7171
Email	wellithgarden@yahoo.co.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Suzuki
Organization	Chiba University
Division name	Department of General Surgery
Zip code	2600856
Address	1-8-1 Inohana, Chuo-ku Chiba, Japan
TEL	043-222-7171
Homepage URL
Email	wellithgarden@yahoo.co.jp

Sponsor
Institute	Chiba University
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	043-222-7171
Email	wellithgarden@yahoo.co.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	2022 Year 11 Month 09 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	105
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	2016 Year 01 Month 01 Day
Date of IRB	2022 Year 01 Month 17 Day
Anticipated trial start date	2022 Year 02 Month 01 Day
Last follow-up date	2022 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	To investigate whether the combination of grip strength and IBPS is a useful new preoperative prognostic factor for pancreatic head cancer undergoing pancreatoduodenectomy

Management information
Registered date	2022 Year 11 Month 07 Day
Last modified on	2022 Year 11 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056298