UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044467 |
|---|---|
| Receipt number | R000050798 |
| Scientific Title | Phase I study for feasibility of less-invasive laparoscopic endoscopic cooperative surgery |
| Date of disclosure of the study information | 2021/07/01 |
| Last modified on | 2021/12/08 11:58:17 |
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Basic information
Public title
Pilot study of less-invasive laparoscopic endoscopic cooperative surgery
Acronym
Pilot study of less-invasive laparoscopic endoscopic cooperative surgery
Scientific Title
Phase I study for feasibility of less-invasive laparoscopic endoscopic cooperative surgery
Scientific Title:Acronym
Phase I study for feasibility of less-invasive laparoscopic endoscopic cooperative surgery
Region
| Japan |
Condition
Condition
Gastric submucosal tumors
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate feasibility and safety of laparoscopic endoscopic cooperative surgery with minimal assistance of laparoscopy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Completeness of endoscopic resection
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
Endoscopic resection and defect closure
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Gastric submucosal tumors that are diagnosed or suspected with GIST, 3cm or less in size
2) Intraluminally- or intramurally-growing type tumors
3) 20 years-old or more
Key exclusion criteria
1) Bleeding tendency
2) Liver cirrhosis with Child-Pugh C
3) Chronic kidney disease on hemodialysis
4) Patient whom doctors in charge determine as an inappropriate for inclusion of the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Goto |
Organization
Nippon Medical School Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
1138603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
0338222131
o-goto@nms.ac.jp
Public contact
Name of contact person
| 1st name | Osamu |
| Middle name | |
| Last name | Goto |
Organization
Nippon Medical School Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
1138603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
0338222131
Homepage URL
o-goto@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Nippon Medical School Hospital Center for Clinical Research
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
Tel
0338222131
o-goto@nms.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
| 2021 | Year | 07 | Month | 01 | 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
| 2021 | Year | 06 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 08 | 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
| 2021 | Year | 06 | Month | 08 | Day |
Last modified on
| 2021 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050798
