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

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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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name