UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026631
Receipt number R000030581
Scientific Title Observational study of feasibility of efficacy and safety of laparoscopy endoscopy cooperative surgery for gastric submucosal tumors
Date of disclosure of the study information 2017/03/22
Last modified on 2018/03/22 13:31:49

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Basic information

Public title

Observational study of feasibility of efficacy and safety of laparoscopy endoscopy cooperative surgery for gastric submucosal tumors

Acronym

Observational study of feasibility of efficacy and safety of laparoscopy endoscopy cooperative surgery for gastric submucosal tumors

Scientific Title

Observational study of feasibility of efficacy and safety of laparoscopy endoscopy cooperative surgery for gastric submucosal tumors

Scientific Title:Acronym

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

1st name
Middle name
Last name Ojima Toshiyasu

Organization

Wakayama Medical University School of Medicine

Division name

Second Department of Surgery

Zip code


Address

811-1 Kimiidera, Wakayama

TEL

073-441-0613

Email

tojima@wakayama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ojima Toshiyasu

Organization

Wakayama Medical University School of Medicine

Division name

Second Department of Surgery

Zip code


Address

811-1 Kimiidera, Wakayama

TEL

073-441-0613

Homepage URL


Email

tojima@wakayama-med.ac.jp


Sponsor or person

Institute

Wakayama Medical University School of Medicine, Second Department of Surgery

Institute

Department

Personal name



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)



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

2017 Year 03 Month 22 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


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.

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

2017 Year 03 Month 21 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030581


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name