UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011619
Receipt number R000013185
Scientific Title A phase II study of ERAS (Enhanced recovery after surgery) protocol in patients undergoing gastrectomy
Date of disclosure of the study information 2013/09/02
Last modified on 2016/01/28 12:05:22

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Basic information

Public title

A phase II study of ERAS (Enhanced recovery after surgery) protocol in patients undergoing gastrectomy

Acronym

ERAS-GC phase II

Scientific Title

A phase II study of ERAS (Enhanced recovery after surgery) protocol in patients undergoing gastrectomy

Scientific Title:Acronym

ERAS-GC phase II

Region

Japan


Condition

Condition

Gastric cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To clarify the feasibility of ERAS protocol in patients undergoing gastrectomy

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Morbidity

Key secondary outcomes

Length of postoperative hospital stay
Completion rate of ERAS protocol
Starting rate of diet at second day after operation
Incidence of anastomotic leakage
Incidence of postoperative pneumonia
Mortality


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

ERAS protocol

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

20 years-old <=

Age-upper limit

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1)Biopsy specimen from the primary lesion shows adenocarcinoma.
2)Curative resection will be performed. Not having esophageal and duodenal invasion
3)Other organ resection is not needed.
4)No limitation in oral intake
5)Epidural anesthesia is allowed.
6)Eastern clinical oncology group performance status is 0.
7)No previous chemotherapy or radiation including those for other cancers.
8)Fulfill all following conditions
WBC > 3,000/mm3
Plt > 100,000/mm3
AST < 100 IU/L
ALT < 100IU/L
T-Bil < 2.0 g/dl
Cre < 1.5mg/dl

Key exclusion criteria

1)Having other active cancers
2)With Psychiatric disorder
3)Receiving steroids
4)With acute myocardial infarction in 6 months or with unstable angina
5)With uncontrolled hypertension
6)With uncontrolled diabetes mellitus
7)With some damage after cerebral infarction
8)With pulmonary disease and require continuous oxygen therapy

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Terashima Masanori

Organization

Shizuoka Cancer Center

Division name

Division of Gastric Surgery

Zip code


Address

1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan

TEL

055-989-5222

Email

n.sugisawa@scchr.jp


Public contact

Name of contact person

1st name
Middle name
Last name Sugisawa Norihiko

Organization

Shizuoka Cancer Center

Division name

Division of Gastric Surgery

Zip code


Address

1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan

TEL

055-989-5222

Homepage URL


Email

n.sugisawa@scchr.jp


Sponsor or person

Institute

Shizuoka Cancer Center

Institute

Department

Personal name



Funding Source

Organization

Shizuoka Cancer Center

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

2013 Year 09 Month 02 Day


Related information

URL releasing protocol


Publication of results

Published


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

Main results already published

Date of protocol fixation

2013 Year 06 Month 04 Day

Date of IRB


Anticipated trial start date

2013 Year 07 Month 29 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

2013 Year 09 Month 01 Day

Last modified on

2016 Year 01 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013185


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name