UMIN-CTR Clinical Trial

Basic information
Public title	A randomized controlled trial of single-incision versus conventional multi-port laparoscopic gastrectomy for clinical stage I gastric cancer
Acronym	A randomized trial of SLG vs. MLG for clinical stage I gastric cancer
Scientific Title	A randomized controlled trial of single-incision versus conventional multi-port laparoscopic gastrectomy for clinical stage I gastric cancer
Scientific Title:Acronym	A randomized trial of SLG vs. MLG for clinical stage I gastric cancer
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the safety and efficacy of single-incision laparoscopic gastrectomy compared to conventional multi-port laparoscopic gastrectomy for clinical stage I gastric cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Degree of postoperative pain
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation	YES
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Single-incision laparoscopic gastrectomy
Interventions/Control_2	Multi-port laparoscopic gastrectomy
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Histologically confirmed gastric adenocarcinoma. (2) Indication of distal gastrectomy. (3) c Stage I gastric cancer. (4) No invasion to the duodenum (5) Body mass index <30. (6) Written informed consent.
Key exclusion criteria	(1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ. (2) Women during pregnancy or breast-feeding. (3) Severe mental disease. (4) Continuous systemic steroid therapy. (5) History of myocardial infarction or unstable angina pectoris within six months. (6) Uncontrollable hypertension. (7) Uncontrollable diabetes millutus. (8) Severe respiratory disease requiring continuous oxygen therapy.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takeshi Omori
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Gastroenterological Surgery
Zip code
Address	1-3-3 Nakamichi, Higashinari-ku, Osaka, Japan
TEL	+81669721181
Email	oomori-ta@mc.pref.osaka.jp

Public contact
Name of contact person	1st name Middle name Last name Takeshi Omori
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Gastroenterological Surgery
Zip code
Address	1-3-3 Nakamichi, Higashinari-ku, Osaka, Japan
TEL	+81669721181
Homepage URL
Email	oomori-ta@mc.pref.osaka.jp

Sponsor
Institute	Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department

Funding Source
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
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	大阪府立成人病センター

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 09 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 30 Day
Date of IRB	2016 Year 02 Month 17 Day
Anticipated trial start date	2016 Year 05 Month 09 Day
Last follow-up date	2021 Year 03 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	2016 Year 05 Month 06 Day
Last modified on	2019 Year 08 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025239