UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035907 |
|---|---|
| Receipt number | 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 | 2021/03/07 10:30:48 |
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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 | Sumida |
| Middle name | |
| Last name | Yorinobu |
Organization
National Hospital Organization Kyushu Medical Center
Division name
Department of Gastroenterology and Clinical Research Institute
Zip code
8108563
Address
1-8-1 Jigyohama, Chuo-Ku, Fukuoka
TEL
0928520700
y.raisin@gmail.com
Public contact
Name of contact person
| 1st name | Sumida |
| Middle name | |
| Last name | Yorinobu |
Organization
National Hospital Organization Kyushu Medical Center
Division name
Department of Gastroenterology and Clinical Research Institute
Zip code
8108563
Address
1-8-1 Jigyohama, Chuo-Ku, Fukuoka
TEL
0928520700
Homepage URL
y.raisin@gmail.com
Sponsor or person
Institute
National Hospital Organization Kyushu Medical Center, Department of Gastroenterology and Clinical Research Institute
Institute
Department
Personal name
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
National Hospital Organization Kyushu Medical Center
Address
1-8-1 Jigyohama, Chuo-Ku, Fukuoka
Tel
0928520700
y.raisin@gmail.com
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
| 2021 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040905
