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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Pancreatic tumor, Biliary tumor, Duodenal tumor, Chronic pancreatitis. | |
Classification by specialty |
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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 |
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Age-upper limit |
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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 |
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Target sample size | 200 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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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 |
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Last modified on |
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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 |