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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004722
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Kagawa university
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005208

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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