UMIN-CTR Clinical Trial

Basic information
Public title	A prospective safety study of laparoscopic total gastrectomy for clinical stageII or III gastric cancer
Acronym	A prospective study of laparoscopic total gastrectomy for advanced gastric cancer
Scientific Title	A prospective safety study of laparoscopic total gastrectomy for clinical stageII or III gastric cancer
Scientific Title:Acronym	A prospective study of laparoscopic total 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 and feasibility of laparoscopic total gastrectomy for clinical stage II/III
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	postoperative complication rate
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	Device,equipment Maneuver
Interventions/Control_1	laparoscopic total 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) Histologically proven gastric adenocarcinoma. (2) Clinical stage II or III according to the 14th edition of Japanese Classification of Gastric Carcinoma. (3) Aged over 20. (4) PS (ECOG) of 0 or 1. (5) No history of upper abdominal surgery and no history of intestinal resection except for appendectomy. (6) No prior treatment of chemotherapy or radiation therapy against any other malignancies. History of adjuvant hormone therapy after more than 1 year from the last administration is eligible. (7) Written informed consent.
Key exclusion criteria	(1) Synchronous or metachronous malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy. (2) concurrent resection of other organ. (3) Body mass index less than 30. (4) Infectious disease with systemic therapy indicated. (5) Body temperature of 38 or more degrees Celsius. (6) Pregnancy, possible pregnancy, within 28 days after delivery or breast-feeding. (7) Severe psychiatric disease. (8) Unstable angina pectoris, or history of myocardial infarction within six months. (9) Poorly controlled hypertension. (10) Poorly controlled diabetes mellitus in spite of continuous use of insulin. (11) Severe respiratory disease requiring continuous oxygen therapy.
Target sample size	135

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yasuhiro Kodera
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterological Surgery
Zip code
Address	65, Tsurumai-cho, Showa-ku, Nagoya, Aiti 466-8550, JAPAN
TEL	052-744-2249
Email	ykodera@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Chie Tanaka
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterological Surgery
Zip code
Address	65, Tsurumai-cho, Showa-ku, Nagoya, Aiti 466-8550, JAPAN
TEL	052-744-2249
Homepage URL
Email	chtanaka@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization	none
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

Other administrative information
Date of disclosure of the study information	2016 Year 01 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	Completed
Date of protocol fixation	2016 Year 01 Month 01 Day
Date of IRB	2015 Year 07 Month 03 Day
Anticipated trial start date	2016 Year 01 Month 01 Day
Last follow-up date	2022 Year 12 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 05 Month 28 Day
Last modified on	2022 Year 12 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020467