UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040436 |
|---|---|
| Receipt number | 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 17:18:50 |
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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
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
y-matsugu@hph.pref.hiroshima.jp
Sponsor or person
Institute
Hiroshima Prefectural Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046146
