UMIN-CTR Clinical Trial

Basic information
Public title	Cohort study of laparoscopic gastrectomy for advanced gastric cancer
Acronym	Cohort study of laparoscopic gastrectomy for advanced gastric cancer
Scientific Title	Cohort study of laparoscopic gastrectomy for advanced gastric cancer
Scientific Title:Acronym	Cohort study of laparoscopic gastrectomy for advanced 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 of laparoscopic gastrectomy for advanced gastric cancer
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Positive rate of peritoneal cytology for carcinoma cells after surgery
Key secondary outcomes	Numbers of Group 2 lymph nodes, Proportion of laparoscopic gastrectomy completion, Incidence of adverse events, Incidence of anastomotic leakage or pancreatic fistula, Relapse-free survival, Overall 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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Aged 20 year over 2)PS (ECOG) 0 or 1 3)BMI < 30 4)Histologically proven gastric adenocarcinoma 5)Clinical T2, T3, T4a 6)Clinical N0-2, H0, P0, M0 without bulky N2 7)Resectability of RO 8)Written informed consent
Key exclusion criteria	1)With heart disease associated with symptoms 2)Wiht pulmorary disease requiring continuous oxygen therapy
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Keiji Middle name Last name Hayata
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Zip code	641-8510
Address	811-1 Kimiidera, Wakayama, Japan
TEL	073-441-0613
Email	keiji@wakayama-med.ac.jp

Public contact
Name of contact person	1st name Keiji Middle name Last name Hayata
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Zip code	641-8510
Address	811-1 Kimiidera, Wakayama, Japan
TEL	073-441-0613
Homepage URL
Email	keiji@wakayama-med.ac.jp

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

Funding Source
Organization	Second Department of Surgery, Wakayama Medical University
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	Wakayama Medical University
Address	811-1 Kimiidera Wakayama
Tel	073-447-2300
Email	keiji@wakayma-med.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

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 01 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 11 Month 12 Day
Date of IRB	2015 Year 11 Month 20 Day
Anticipated trial start date	2015 Year 12 Month 01 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 11 Month 28 Day
Last modified on	2019 Year 12 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028781