UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of gastrectomy for gastrointestinal stromal tumor(GIST) in the stomach by hybrid natural orifice transluminal endoscopic surgery(NOTES).
Title of the study (Brief title)	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	Mori Hirohito
Organization	Kagawa university
Division name	Dept.Gastroenterology and Neurology
Address	1750-1 Miki,Kida, Kagawa
TEL
Email

Public contact
Name of contact person	Mori Hirohito
Organization	Kagawa university
Division name	Dept.Gastroenterology and Neurology
Address	1750-1 Miki Kida Kagawa Japan
TEL
Homepage URL
Email

Sponsor
Institute	Kagawa university
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 03 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005208