UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001513 |
|---|---|
| Receipt number | R000001817 |
| Scientific Title | Laparoscopy Versus Open Distal Gastrectomy for Early Gastric Cancer: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2013/02/20 |
| Last modified on | 2008/11/18 16:55:46 |
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Basic information
Public title
Laparoscopy Versus Open Distal Gastrectomy for Early Gastric Cancer: A Randomized Controlled Trial
Acronym
Laparoscopy-Assisted Distal Gastrectomy
Scientific Title
Laparoscopy Versus Open Distal Gastrectomy for Early Gastric Cancer: A Randomized Controlled Trial
Scientific Title:Acronym
Laparoscopy-Assisted Distal Gastrectomy
Region
| Japan |
Condition
Condition
Early gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to compare, with the use of a randomized control trial (RCT), laparoscopy-assisted distal gastrectomy (LADG) and conventional open distal gastrectomy (ODG) for gastric cancer regarding clinical outcomes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
The short term primary outcome measure was defined as the intensity of post-operative use of analgesics. Long term primary outcome was overall survival.
Key secondary outcomes
Short term secondary outcomes were intraoperative and postoperative complication rates, days of post-operative hospitalization, and post-operative inconveniences such as days of fever (> 37 degrees Celsius), days to first flatus, VAS pain scores, and blood loss.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
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
| Medicine |
Interventions/Control_1
Laparoscopy assisted distal gasterctomy
Interventions/Control_2
Open distal gastrectomy
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
Patients were eligible for inclusion if they were over 20 years of age and under 75 and if they were diagnosed as having gastric cancer in the mid or lower parts of the stomach with indication for distal gastrectomy.
Key exclusion criteria
Exclusion criteria were past history of gastric cancer, having received open surgery of the upper abdomen, past history of other types of cancers and cancer treatmentd, serious heart, lung, kidney, blood and/or metabolic diseases, Class III or IV of the New York Heart Association classification of cardiac patients, and Class III of Hugh-Jones dyspnea criteria.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Sakuramoto |
Organization
Kitasato University School of Medicine
Division name
Department of Surgery
Zip code
Address
2-1-1 Asamizodai, Sagamihara, Kanagawa 228-8520, Japan
TEL
+81-42-748-9111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Leon Bax |
Organization
Kitasato University School of Medicine
Division name
Kitasato Clinical Research Center
Zip code
Address
1-15-1 Kitasato, Sagamihara, Kanagawa 228-8555, Japan
TEL
+81-42-778-8111
Homepage URL
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
None
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 | 02 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2005 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 11 | Month | 18 | Day |
Last modified on
| 2008 | 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=R000001817
