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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040436
Receipt No. R000046146
Scientific Title Evaluation of an Enhanced Recovery After Surgery (ERAS) program incorporating early enteral nutrition for pancreaticoduodenectomy.
Date of disclosure of the study information 2020/06/01
Last modified on 2020/05/18

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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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