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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044467
Receipt No. 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 2021/06/08

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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
Email 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
Email o-goto@nms.ac.jp

Sponsor
Institute Nippon Medical School Hospital
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2021 Year 06 Month 08 Day
Date of IRB
Anticipated trial start date
2021 Year 07 Month 01 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 06 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050798

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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