UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004722
Receipt number R000005208
Scientific Title Assessment of gastrectomy for gastrointestinal stromal tumor(GIST) in the stomach by hybrid natural orifice transluminal endoscopic surgery(NOTES).
Date of disclosure of the study information 2010/12/14
Last modified on 2018/10/11 17:01:59

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Basic information

Public title

Assessment of gastrectomy for gastrointestinal stromal tumor(GIST) in the stomach by hybrid natural orifice transluminal endoscopic surgery(NOTES).

Acronym

Pure NOTES

Scientific Title

Assessment of gastrectomy for gastrointestinal stromal tumor(GIST) in the stomach by hybrid natural orifice transluminal endoscopic surgery(NOTES).

Scientific Title:Acronym

Pure NOTES

Region

Japan


Condition

Condition

Gastric GIST(gastrointestinal stromaltumor) or SMT(submucosal tumor)

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Assess the efficacy and safety of gastrectomy by hybrid NOTES for the type of GIST in the stomach which lesions are clearly visible by endoscope but difficult by laparoscope.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I


Assessment

Primary outcomes

Relapse free survival

Key secondary outcomes

Intra and post-operative morbidity


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Single blind -participants are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

Combined endoscopic and laparoscopic gastrectomy for gastrointestinal stromal tumor in the stomach.
Closing the site of gastrotomy by closure device for full-thickness suturing.

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

85 years-old >

Gender

Male and Female

Key inclusion criteria

Those who have gastric submucosal tumor of endogastric type, larger than 3 cm in diameter or less than 3 cm in diameter with ulcer.
Those who signed informed consent.

Key exclusion criteria

Those who are judged unable to withstand surgery by the investigators with the preoperative assessment.
Those who have history of postoperative ileus.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mori Hirohito

Organization

Kagawa university

Division name

Dept.Gastroenterology and Neurology

Zip code


Address

1750-1 Miki,Kida, Kagawa

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Mori Hirohito

Organization

Kagawa university

Division name

Dept.Gastroenterology and Neurology

Zip code


Address

1750-1 Miki Kida Kagawa Japan

TEL


Homepage URL


Email



Sponsor or person

Institute

Kagawa university

Institute

Department

Personal name



Funding Source

Organization

Kagawa university

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

2010 Year 12 Month 14 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

Completed

Date of protocol fixation

2010 Year 03 Month 10 Day

Date of IRB


Anticipated trial start date

2010 Year 03 Month 19 Day

Last follow-up date


Date of closure to data entry

2018 Year 09 Month 10 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 12 Month 14 Day

Last modified on

2018 Year 10 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005208


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name