UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009163 |
|---|---|
| Receipt number | R000010751 |
| Scientific Title | Randomized phase III trial of benefit of additional cholecystectomy in total gastrectomy for gastric cancer patients |
| Date of disclosure of the study information | 2012/10/25 |
| Last modified on | 2016/02/25 15:13:11 |
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Basic information
Public title
Randomized phase III trial of benefit of additional cholecystectomy in total gastrectomy for gastric cancer patients
Acronym
Randomized phase III trial of benefit of additional cholecystectomy in total gastrectomy for gastric cancer patients
Scientific Title
Randomized phase III trial of benefit of additional cholecystectomy in total gastrectomy for gastric cancer patients
Scientific Title:Acronym
Randomized phase III trial of benefit of additional cholecystectomy in total gastrectomy for gastric cancer patients
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We compare to the additional cholecystectomy in the total gastrectomy for the gastric cancer patients in terms of postoperative complications and postoperative clinical course, and determine the benefit of the additional cholecystectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Incidence of postoperative complications
Key secondary outcomes
Incidence of perioperative complications
Postoperative weight loss
Nutritive conditions
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
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
cholecystectomy
Interventions/Control_2
preservation
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)total gastrectomy
2)curative (R0) resection
3)no severe disturbance of liver function and renal function
4)an age of 85 years or younger
5)writen informed consent
Key exclusion criteria
1)non-curative (R1) resection
2)additional pancreatectomy, hepatectomy
3)severe complication such as interstitial pneumonia, uncontrolled DM, ischemic heart disease, cardiac failure
4)liver cirrhosis, active hapatitis
5)haemodialysis
Target sample size
380
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiyasu Ojima |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
Address
811-1, Kimiidera, 811-1, Kimiidera, Wakayama 641-8510, Japan
TEL
073-441-0613
tojima@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiyasu Ojima |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
Address
811-1, Kimiidera, Wakayama 641-8510, Japan
TEL
073-441-0613
Homepage URL
tojima@wakayama-med.ac.jp
Sponsor or person
Institute
Second Department of Surgey
Wakayama Medical Univesity
Institute
Department
Personal name
Funding Source
Organization
Second Department of Surgey
Wakayama Medical Univesity
Organization
Division
Category of Funding Organization
Other
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
| 2012 | Year | 10 | Month | 25 | 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
| 2011 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | 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
| 2012 | Year | 10 | Month | 22 | Day |
Last modified on
| 2016 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010751
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
