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
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
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
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
