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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035907
Receipt No. R000040905
Scientific Title The effectiveness of Per oral Endoscopic Tumor Resection for gastrointestinal submucosal tumor
Date of disclosure of the study information 2019/02/18
Last modified on 2019/02/18

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Basic information
Public title The effectiveness of Per oral Endoscopic Tumor Resection for gastrointestinal submucosal tumor
Acronym The effectiveness of Per oral Endoscopic Tumor Resection for SMT

Scientific Title The effectiveness of Per oral Endoscopic Tumor Resection for gastrointestinal submucosal tumor
Scientific Title:Acronym The effectiveness of Per oral Endoscopic Tumor Resection for SMT

Region
Japan

Condition
Condition Gastrointestinal submucosal tumor
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The safety of Peroral submucosal tumor resection for SMT
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Complete resection rate for Per oral Endoscopic Tumor Resection
Key secondary outcomes Complication rate by endoscopic resection, tumor diameter, localization of lesion, treatment time, hospital stay, tumor recurrence

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 Per oral endoscopic tumor resection
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Patients who were diagnosed with submucosal tumors of the digestive tract by upper and lower gastrointestinal endoscopy and Endoscopic ultrasound.

Patients who are not on surgical indications on guidelines, but who pathological tissue diagnosis is desired for

Patients who are expected to have difficulty collecting tissues by endoscopic ultrasound guided fine needle aspiration

Patients who are considered to be useful for endoscopic resection as a diagnostic treatment
Key exclusion criteria Patients who can not stop two or more anti-thrombotic medications

Patients with bleeding tendency

Patients judged inappropriate by the attending physician

Patients who can not obtain informed consent
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yorinobu Sumida
Organization National Hospital Organization Kyushu Medical Center
Division name Department of Gastroenterology and Clinical Research Institute
Zip code
Address 1-8-1 Jigyohama, Chuo-Ku, Fukuoka
TEL 0928520700
Email y.raisin@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yorinobu Sumida
Organization National Hospital Organization Kyushu Medical Center
Division name Department of Gastroenterology and Clinical Research Institute
Zip code
Address 1-8-1 Jigyohama, Chuo-Ku, Fukuoka
TEL 0928520700
Homepage URL
Email y.raisin@gmail.com

Sponsor
Institute National Hospital Organization Kyushu Medical Center, Department of Gastroenterology and Clinical Research Institute
Institute
Department

Funding Source
Organization National Hospital Organization Kyushu Medical Center, Department of Gastroenterology and Clinical Research Institute
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
2019 Year 02 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 Open public recruiting
Date of protocol fixation
2018 Year 03 Month 10 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2024 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2019 Year 02 Month 17 Day
Last modified on
2019 Year 02 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040905

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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