UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039807 |
|---|---|
| Receipt number | R000045398 |
| Scientific Title | Prospective study for evaluating the safety of LECS as the option treatment for elderly gastric cancer |
| Date of disclosure of the study information | 2020/03/13 |
| Last modified on | 2022/03/16 14:16:32 |
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Basic information
Public title
Prospective study for evaluating the safety of LECS as the option treatment for elderly gastric cancer
Acronym
A prospective study of the LECS for elderly gastric cancer
Scientific Title
Prospective study for evaluating the safety of LECS as the option treatment for elderly gastric cancer
Scientific Title:Acronym
A prospective study of the LECS for elderly gastric cancer
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of LECS for elderly gastric cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence rate of postoperative complications (Clavien Dindo III or above)
Key secondary outcomes
Overall survival (OS), Disease specific survival (DSS), Blood loss, Operation time,
Postoperative hospital stay, Lean body mass, QOL
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
LECS
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
| 75 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Histologically proven gastric cancer
2) Preoperatively diagnosed as "advanced gastric cancer within 5cm" or "early gastric cancer with relative indication according to guideline or early gastric cancer indicative of ESD treatment, but technically difficult for ESD"
3) Neither Borrmann type 4 nor large (>=8 cm) type 3
4) Patient who can do oral intake
5) With written informed consent before surgery
Key exclusion criteria
1) Patients who can not be applied general aneshtesia
2) Patients without preoperative informed consent
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Hiki |
Organization
Kitasato University School of Medicine
Division name
Department of Upper Gastrointestinal Surgery
Zip code
2520374
Address
1-15-1 Kitasato, Minamiku, Sagamihara, Kanagawa, Japan
TEL
042-778-8111
nhiki@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Ethics Examination Office |
| Middle name | |
| Last name | Kitasato University Hospital |
Organization
Kitasato University Hospital
Division name
Ethics Examination Office
Zip code
2520374
Address
1-15-1 Kitasato, Minamiku, Sagamihara, Kanagawa, Japan
TEL
042-778-8111
Homepage URL
rinrib@med.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kitasato University School of Medicine
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
Kitasato University School of Medicine
Address
1-15-1 Kitasato, Minamiku, Sagamihara, Kanagawa, Japan
Tel
042-778-8111
mwashio@kitasato-u.ac.jp
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
| 2020 | Year | 03 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 13 | Day |
Last modified on
| 2022 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045398
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
