UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II study of laparoscopy assisted total / proximal gastrectomy for gastric cancer
Title of the study (Brief title)	A phase II study of laparoscopy assisted total / proximal gastrectomy for gastric cancer
Region	Japan

Condition
Condition	cStage I gastric cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety of laparoscopy assisted total or prioximal gastrectomy (LATG/PG) with nodal dissection for clinical stage IA or IB 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
Key secondary outcomes	proportion of LAG completion, proportion of conversion to open surgery, proportion of anastomotic stenosis, Incidence of anastomotic stenosis, pancreatic fistula or peritoneal abscess, overall survival, recurrence-free survival, adverse events, short-term clinical outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Laparoscopy assisted total and proximal 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) Histologically proven gastric adenocarcinoma. 2) cStage IA or IB. 3) No indication of endoscopic mucosal resection (EMR) in a cN0 case. 4) Tumor located in the upper 1/3 of the stomach and indication for total or proximal gastrectomy. 5) No invasion to duodenum. 6) Aged 20 to 85 year. 7) Body mass index <30. 8) 13) 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	50

Research contact person
Name of lead principal investigator	Kazunari Misawa
Organization	Aichi Cancer Center Hospital
Division name	Department of Gastroenterological Surgery
Address	1-1 Kanokoden Chikuda-ku Nagoya Japan
TEL	0527626111
Email	misawakzn@aichi-cc.jp

Public contact
Name of contact person	Kazunari Misawa
Organization	Aichi Cancer Center Hospital
Division name	Department of Gastroenterological Surgery
Address	1-1 Kanokoden Chikuda-ku Nagoya Japan
TEL	0527626111
Homepage URL
Email	misawakzn@aichi-cc.jp

Sponsor
Institute	Aichi Cancer Center Hospital
Institute
Department

Funding Source
Organization	Aichi Cancer Center Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	愛知県がんセンター（愛知県）

Other administrative information
Date of disclosure of the study information	2014 Year 08 Month 22 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2009 Year 09 Month 01 Day
Anticipated trial start date	2009 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 08 Month 22 Day
Last modified on	2018 Year 07 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017353