UMIN-CTR Clinical Trial

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
Email	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
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	National Hospital Organization Kyushu Medical Center
Address	1-8-1 Jigyohama, Chuo-Ku, Fukuoka
Tel	0928520700
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040905