UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory study of laparoscopic palliative gastric surgery for Stage IV gastric cancer
Acronym	Exploratory study of laparoscopic palliative gastric surgery for Stage IV gastric cancer
Scientific Title	Exploratory study of laparoscopic palliative gastric surgery for Stage IV gastric cancer
Scientific Title:Acronym	Exploratory study of laparoscopic palliative gastric surgery for Stage IV gastric cancer
Region	Japan

Condition
Condition	Stage IV gastric cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Safety of laparoscopic palliative surgery for Stage IV gastric cancer
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The ratio of the patients who completed the treatment
Key secondary outcomes

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	Laparoscopic palliative gastric surgery
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Pathologically diagnosed gastric cancer. 2)Stage Iv gastric cancer diagnosed by CT or laparoscopic diagnosis. 3)Patients who con not take food by tumor bleeding or tumor stenosis. 4) Written informed consent must be taken by patients
Key exclusion criteria	1)Mental disease. 2)Sever respiratory complication. 3)Sever abdominal adhesion. 4)Severe circulationg complication. 5)Physician concludes that the patient's participation in this trial is inappropriate.
Target sample size	50

Research contact person
Last name of lead principal investigator	1st name Akinobu Middle name Last name Taketomi
Organization	Hokkaido University Graduate School of Medicine
Division name	Gastroenterological Surgery I
Zip code	060-8638
Address	Kita 15, Nishi 7, Kita-ku, Sapporo, Japan
TEL	011-706-5927
Email	taketomi@med.hokudai.ac.jp

Public contact
1st name of contact person	1st name Tadashi Middle name Last name Yoshida
Organization	Hokkaido University Graduate School of Medicine
Division name	Gastroenterological Surgery I
Zip code	060-8638
Address	Kita 15, Nishi 7, Kita-ku, Sapporo, Japan
TEL	011-706-5927
Homepage URL
Email	ta73825@dg7.so-net.ne.jp

Sponsor
Institute	Gastroenterological Surgery I,Hokkaido University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Gastroenterological Surgery I,Hokkaido University Graduate School of Medicine
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	Hokkaido University Graduate School of Medicine
Address	Kita 15, Nishi 7, Kita-ku, Sapporo, Japan
Tel	011-706-5927
Email	h.kawamura@med.hokudai.ac.jp

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	北海道大学大学院医学研究科消化器外科学分野Ｉ（北海道）

Other administrative information
Date of disclosure of the study information	2015 Year 11 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	Enrolling by invitation
Date of protocol fixation	2015 Year 09 Month 29 Day
Date of IRB	2015 Year 11 Month 18 Day
Anticipated trial start date	2015 Year 11 Month 18 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 10 Month 28 Day
Last modified on	2019 Year 05 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022607