UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004722 |
|---|---|
| Receipt number | R000005208 |
| Scientific Title | Assessment of gastrectomy for gastrointestinal stromal tumor(GIST) in the stomach by hybrid natural orifice transluminal endoscopic surgery(NOTES). |
| Date of disclosure of the study information | 2010/12/14 |
| Last modified on | 2018/10/11 17:01:59 |
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Basic information
Public title
Assessment of gastrectomy for gastrointestinal stromal tumor(GIST) in the stomach by hybrid natural orifice transluminal endoscopic surgery(NOTES).
Acronym
Pure NOTES
Scientific Title
Assessment of gastrectomy for gastrointestinal stromal tumor(GIST) in the stomach by hybrid natural orifice transluminal endoscopic surgery(NOTES).
Scientific Title:Acronym
Pure NOTES
Region
| Japan |
Condition
Condition
Gastric GIST(gastrointestinal stromaltumor) or SMT(submucosal tumor)
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Assess the efficacy and safety of gastrectomy by hybrid NOTES for the type of GIST in the stomach which lesions are clearly visible by endoscope but difficult by laparoscope.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Relapse free survival
Key secondary outcomes
Intra and post-operative morbidity
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Combined endoscopic and laparoscopic gastrectomy for gastrointestinal stromal tumor in the stomach.
Closing the site of gastrotomy by closure device for full-thickness suturing.
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those who have gastric submucosal tumor of endogastric type, larger than 3 cm in diameter or less than 3 cm in diameter with ulcer.
Those who signed informed consent.
Key exclusion criteria
Those who are judged unable to withstand surgery by the investigators with the preoperative assessment.
Those who have history of postoperative ileus.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mori Hirohito |
Organization
Kagawa university
Division name
Dept.Gastroenterology and Neurology
Zip code
Address
1750-1 Miki,Kida, Kagawa
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mori Hirohito |
Organization
Kagawa university
Division name
Dept.Gastroenterology and Neurology
Zip code
Address
1750-1 Miki Kida Kagawa Japan
TEL
Homepage URL
Sponsor or person
Institute
Kagawa university
Institute
Department
Personal name
Funding Source
Organization
Kagawa university
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
| 2010 | Year | 12 | Month | 14 | 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
| 2010 | Year | 03 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | Month | 19 | Day |
Last follow-up date
Date of closure to data entry
| 2018 | Year | 09 | Month | 10 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 14 | Day |
Last modified on
| 2018 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005208
