UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Observational study of feasibility of efficacy and safety of laparoscopy endoscopy cooperative surgery for gastric submucosal tumors
Title of the study (Brief title)	Observational study of feasibility of efficacy and safety of laparoscopy endoscopy cooperative surgery for gastric submucosal tumors
Region	Japan

Condition
Condition	Gastric submucosal tumors
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of efficacy and safety in laparoscopy endoscopy cooperative surgery for gastric submucosal tumors
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Postoperative complication rates in laparoscopy endoscopy cooperative surgery
Key secondary outcomes	Surgical process (operative time, intraoperative bleeding, the number of ports, the use of the saturation, cost, the rates of laparotomy transition), postoperative course (oral intake, length of stay, inflammatory findings, the rates of late complications, stenosis).

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	1. Gastric submucosal tumors 2. Performance status o and 1 3. Plt => 100,000/mm3 Creatinine <= 2.0 mg/dl AST <= 200 IU/L ALT <= 200 IU/L T-bil <= 2.0 mg/dl Hb => 8.0 g/dl 4. Patients who gave written informed consent before entry in this study
Key exclusion criteria	1. Ischemic heart disease 2. Liver cirrhosis, active hepatitis 3. Interstitial pneumonia 4. Haemodialysis 5. Both malignant disorder 6. Severe abdominal adhesion 7. Doctor's decision not to register to this regimen
Target sample size	20

Research contact person
Name of lead principal investigator	Ojima Toshiyasu
Organization	Wakayama Medical University School of Medicine
Division name	Second Department of Surgery
Address	811-1 Kimiidera, Wakayama
TEL	073-441-0613
Email	tojima@wakayama-med.ac.jp

Public contact
Name of contact person	Ojima Toshiyasu
Organization	Wakayama Medical University School of Medicine
Division name	Second Department of Surgery
Address	811-1 Kimiidera, Wakayama
TEL	073-441-0613
Homepage URL
Email	tojima@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University School of Medicine, Second Department of Surgery
Institute
Department

Funding Source
Organization	Wakayama Medical University School of Medicine, Second Department of Surgery
Organization
Division
Category of Funding Organization	Self funding
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	2017 Year 03 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 21 Day
Anticipated trial start date	2017 Year 03 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	Laparoscopic and endoscopic cooperative surgery is a feasible treatment procedure for intraluminal gastric gastrointestinal stromal tumors compared to endoscopic intragastric surgery. Ojima T, Nakamura M, Nakamori M, Takifuji K, Hayata K, Katsuda M, Takei Y, Yamaue H. Surg Endosc. 2018 Jan;32(1):351-357.
Other related information	We collect data.

Management information
Registered date	2017 Year 03 Month 21 Day
Last modified on	2018 Year 03 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030581