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

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 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

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

Value
https://center6.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