UMIN-CTR Clinical Trial

Basic information
Public title	Feasibility and safety of laparoscopic gastrectomy for clinical Stage II or more advanced gastric cancer
Acronym	Feasibility and safety of laparoscopic gastrectomy for clinical Stage II or more advanced gastric cancer
Scientific Title	Feasibility and safety of laparoscopic gastrectomy for clinical Stage II or more advanced gastric cancer
Scientific Title:Acronym	Feasibility and safety of laparoscopic gastrectomy for clinical Stage II or more advanced gastric cancer
Region	Japan

Condition
Condition	clinical Stage II or more advanced gastric cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the feasibility and safety of laparoscopic gastrectomy for clinical Stage II or more advanced gastric cancer
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Incidence of anastomotic leakage or pancreatic fistula
Key secondary outcomes	Incidence of adverse events, proportion of laparoscopic gastrectomy completion, relapse-free survival

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 gastrectomy
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	1) Aged 20 to 85 year 2) PS (ECOG) 0 or 1 3) Body mass index < 30 4) Histologically proven gastric adenocarcinoma 5) Clinical Stage II or III advanced gastric cancer 6) Written informed consent
Key exclusion criteria	1)Previous laparotomy (excluding appendectomy and laparoscopic surgery) 2)Indication for emergent surgery 3)With active intestinal bleeding 4)With bowel obstruction 5)With heart disease associated with symptoms(including unstable ungina or acute myocardial infarction or heart failure) 6)With pulmonary disease requiring continuous oxygen therapy 7)With uncontrolled diabetes mellitus 8)With uncontrolled hypertension 9)With Acute myocardial infarction in 6 months 10)With a history of previous deep thrombophlebitis or pulmonary embolism
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Eigo Middle name Last name Otsuji
Organization	Kyoto Prefectural University of Medicine
Division name	Division of Digestive Surgery
Zip code	602-8566
Address	465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL	075-251-5527
Email	otsuji@koto.kpu-m.ac.jp

Public contact
Name of contact person	1st name Atsushi Middle name Last name Shiozaki
Organization	Kyoto Prefectural University of Medicine
Division name	Division of Digestive Surgery
Zip code	602-8566
Address	465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL	075-251-5527
Homepage URL
Email	shiozaki@koto.kpu-m.ac.jp

Sponsor
Institute	Division of Digestive Surgery, Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	Division of Digestive Surgery, Kyoto Prefectural University 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	Kyoto Prefectural University of Medicine
Address	465 Kajii-cho, Kamigyo-ku, Kyoto
Tel	075-251-5337
Email	rinri@koto.kpu-m.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	京都府立医科大学

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 02 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	Terminated
Date of protocol fixation	2015 Year 11 Month 04 Day
Date of IRB	2015 Year 11 Month 04 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date	2016 Year 04 Month 01 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 11 Month 04 Day
Last modified on	2021 Year 05 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022683