UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019547 |
|---|---|
| Receipt number | R000022607 |
| Scientific Title | Exploratory study of laparoscopic palliative gastric surgery for Stage IV gastric cancer |
| Date of disclosure of the study information | 2015/11/18 |
| Last modified on | 2019/05/01 23:29:36 |
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Basic information
Public title
Exploratory study of laparoscopic palliative gastric surgery for Stage IV gastric cancer
Acronym
Exploratory study of laparoscopic palliative gastric surgery for Stage IV gastric cancer
Scientific Title
Exploratory study of laparoscopic palliative gastric surgery for Stage IV gastric cancer
Scientific Title:Acronym
Exploratory study of laparoscopic palliative gastric surgery for Stage IV gastric cancer
Region
| Japan |
Condition
Condition
Stage IV gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Safety of laparoscopic palliative surgery for Stage IV gastric cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The ratio of the patients who completed the treatment
Key secondary outcomes
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
| Maneuver |
Interventions/Control_1
Laparoscopic palliative gastric surgery
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Pathologically diagnosed gastric cancer.
2)Stage Iv gastric cancer diagnosed by CT or laparoscopic diagnosis.
3)Patients who con not take food by
tumor bleeding or tumor stenosis.
4) Written informed consent must be taken by patients
Key exclusion criteria
1)Mental disease.
2)Sever respiratory complication.
3)Sever abdominal adhesion.
4)Severe circulationg complication.
5)Physician concludes that the patient's participation in this trial is inappropriate.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Akinobu |
| Middle name | |
| Last name | Taketomi |
Organization
Hokkaido University Graduate School of Medicine
Division name
Gastroenterological Surgery I
Zip code
060-8638
Address
Kita 15, Nishi 7, Kita-ku, Sapporo, Japan
TEL
011-706-5927
taketomi@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Yoshida |
Organization
Hokkaido University Graduate School of Medicine
Division name
Gastroenterological Surgery I
Zip code
060-8638
Address
Kita 15, Nishi 7, Kita-ku, Sapporo, Japan
TEL
011-706-5927
Homepage URL
ta73825@dg7.so-net.ne.jp
Sponsor or person
Institute
Gastroenterological Surgery I,Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Gastroenterological Surgery I,Hokkaido University Graduate School of Medicine
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
Hokkaido University Graduate School of Medicine
Address
Kita 15, Nishi 7, Kita-ku, Sapporo, Japan
Tel
011-706-5927
h.kawamura@med.hokudai.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
北海道大学大学院医学研究科消化器外科学分野Ｉ（北海道）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 18 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 09 | Month | 29 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2019 | Year | 12 | 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
| 2015 | Year | 10 | Month | 28 | Day |
Last modified on
| 2019 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022607
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
