UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized clinical trial of an enhanced recovery after surgery protocol in patients undergoing pancreaticoduodenectomy
Title of the study (Brief title)	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	Ryuichi Yoshida
Organization	Okayama University Hospital
Division name	Department of Hepato-biliary-pancreatic Surgery
Address	2-5-1, Shikata cho, Kita ku, Okayama city
TEL	086-235-7257
Email	ryuichi-yoshida@md.okayama-u.ac.jp

Public contact
Name of contact person	Kosei Takagi
Organization	Okayama University Hospital
Division name	Department of Hepato-biliary-pancreatic Surgery
Address	2-5-1, Shikata cho, Kita ku, Okayama city
TEL	086-235-7257
Homepage URL
Email	kosei0913@hotmail.co.jp

Sponsor
Institute	Okayama University Graduate School of Medicine and Dentistry, Department of Gastroenterological Surgery
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 05 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016216