UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014068 |
|---|---|
| Receipt number | R000016216 |
| Scientific Title | Randomized clinical trial of an enhanced recovery after surgery protocol in patients undergoing pancreaticoduodenectomy |
| Date of disclosure of the study information | 2014/05/26 |
| Last modified on | 2016/11/18 11:08:53 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Randomized clinical trial of an enhanced recovery after surgery protocol in patients undergoing pancreaticoduodenectomy
Acronym
Randomized clinical trial of an enhanced recovery after surgery protocol in patients undergoing pancreaticoduodenectomy
Scientific Title
Randomized clinical trial of an enhanced recovery after surgery protocol in patients undergoing pancreaticoduodenectomy
Scientific Title:Acronym
Randomized clinical trial of an enhanced recovery after surgery protocol in patients undergoing pancreaticoduodenectomy
Region
| Japan |
Condition
Condition
Patients to require pancreaticoduodenectomy
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficiency of an enhanced recovery after surgery(ERAS) protocol in patients undergoing pancreaticoduodenectomy(PD)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
median length of postoperative hospital stay
Key secondary outcomes
(1)postoperative morbidity/mortality
(2)immune and metabolism response
(3)Compliance with components of the enhanced recovery after surgery (ERAS) protocol
(4)mean medical cost
(5)Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
ERAS group which receive ERAS protocols
Interventions/Control_2
control group which receive standard cares
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients to require pancreaticoduodenectomy
Key exclusion criteria
(1)failure to obtain consent
(2)severe respiratory dysfunction (arterial PaO2 < 70 mmHg)
(3)severe cardiac dysfunction (NYHA > 2)
(4)severe hepatic dysfunction (Child Pugh class C)
(5)severe renal dysfunction (hemodialysis)
(6)pregnancy
(7)preoperative chemotherapy and/or radiation therapy
(8)acute bacterial or viral infections
(9)severe psychiatric disorder
(10)immunocompromised status
(11)advanced malignancy
(12)palliative surgery
(13)emergency surgery
(14)investigator not available
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryuichi Yoshida |
Organization
Okayama University Hospital
Division name
Department of Hepato-biliary-pancreatic Surgery
Zip code
Address
2-5-1, Shikata cho, Kita ku, Okayama city
TEL
086-235-7257
ryuichi-yoshida@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kosei Takagi |
Organization
Okayama University Hospital
Division name
Department of Hepato-biliary-pancreatic Surgery
Zip code
Address
2-5-1, Shikata cho, Kita ku, Okayama city
TEL
086-235-7257
Homepage URL
kosei0913@hotmail.co.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine and Dentistry, Department of Gastroenterological Surgery
Institute
Department
Personal name
Funding Source
Organization
Okayama University Graduate School of Medicine and Dentistry, Department of Gastroenterological Surgery
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 05 | Month | 26 | 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
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
| 2014 | Year | 05 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 26 | Day |
Last modified on
| 2016 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016216
