UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of multidisciplinary team management in pancreaticoduodenectomy implementing an Enhanced Recovery After Surgery (ERAS) program.
Acronym	HPH study of ERAS_PD
Scientific Title	Evaluation of an Enhanced Recovery After Surgery (ERAS) program incorporating early enteral nutrition for pancreaticoduodenectomy.
Scientific Title:Acronym	HPH study of ERAS_PD
Region	Japan

Condition
Condition	Pancreatic tumor, Biliary tumor, Duodenal tumor, Chronic pancreatitis.
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Safety, Efficacy
Basic objectives2	Others
Basic objectives -Others	Assessment of perioperative nutritional status.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Postoperative length of stay (LOS)
Key secondary outcomes	Postoperative complication rate Perioperative energy and protein intake

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Pancreaticoduodenectomy cases in Hiroshima Prefectural Hospital (2007-2018).
Key exclusion criteria	Severe organ dysfunction Severe psychiatric disease Severe neuromuscular disease Simultaneous resection of other gastroenterological cancer Emergency operation
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Yasuhiro Middle name Last name Matsugu
Organization	Hiroshima Prefectural Hospital
Division name	Department of Clinical Nutrition / Department of Gastroenterological, Breast and Transplant Surgery
Zip code	7348530
Address	1-5-54, Ujina-Kanda, Minami-ku, Hiroshima
TEL	0822541818
Email	y-matsugu@hph.pref.hiroshima.jp

Public contact
Name of contact person	1st name Yasuhiro Middle name Last name Matsugu
Organization	Hiroshima Prefectural Hospital
Division name	Department of Clinical Nutrition / Department of Gastroenterological, Breast and Transplant Surgery
Zip code	7348530
Address	1-5-54, Ujina-Kanda, Minami-ku, Hiroshima
TEL	0822541818
Homepage URL
Email	y-matsugu@hph.pref.hiroshima.jp

Sponsor
Institute	Hiroshima Prefectural Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hiroshima Prefectural Hospital
Address	1-5-54, Ujina-Kanda, Minami-ku, Hiroshima
Tel	0822541818
Email	yaku8989@kud.biglobe.ne.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	2020 Year 06 Month 01 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	203
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	2010 Year 08 Month 01 Day
Date of IRB	2017 Year 09 Month 26 Day
Anticipated trial start date	2010 Year 10 Month 01 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	retrospective analysis of the clinical outcome such as onset of eating and enteral feeding, complete of mobilization, drain removal, postoperative length of stay and complication rates between ERAS group and Control group. Assessment of the perioperative energy and protein intake between E1 group (2010-2013) and E2 group (2014-2018).

Management information
Registered date	2020 Year 05 Month 18 Day
Last modified on	2020 Year 05 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046146

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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