UMIN-CTR Clinical Trial

Basic information
Public title	A prospective feasibility study of reduced-port laparoscopic distal gastrectomy for clinical stage I gastric cancer
Acronym	A prospective feasibility study of reduced-port laparoscopic distal gastrectomy for clinical stage I gastric cancer
Scientific Title	A prospective feasibility study of reduced-port laparoscopic distal gastrectomy for clinical stage I gastric cancer
Scientific Title:Acronym	A prospective feasibility study of reduced-port laparoscopic distal gastrectomy 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 demonstrate the non-inferiority of incidence of postoperative complication of reduced-port laparoscopic distal gastrectomy with lymph node dissection compared with conventional laparoscopic distal gastrectomy for clinical stage IA or IB gastric cancer.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	incidence of postoperative complication
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	Maneuver
Interventions/Control_1	Reduced-port 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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Histologically proven gastric adenocarcinoma. 2) cStage IA(T1N0) or IB(T1N1, T2[MP]N0). 3) Tumor located in the middle or lower third of the stomach, and curative resection is expected to be achivable by distal gastrectomy. 4) Aged 20 to 80 years. 5) Body mass index less than 30. 6) PS (ECOG) of 0 or 1. 7) No history of upper abdominal surgery. 8) No prior treatment of chemotherapy or radiation therapy against any other malignancies.
Key exclusion criteria	1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ. 2) Infectious disease with systemic therapy indicated. 3) Body temperature of 38 or more degrees Celsius. 4) Women during pregnancy or breast-feeding. 5) Severe mental disease. 6) Continuous systemic steroid therapy. 7) Unstable angina pectoris, or history of myocardial infarction within six months. 8) Uncontrollable hypertension. 9) Uncontrollable diabetes millutus. 10) Severe respiratory disease requiring continuous oxygen therapy.
Target sample size	55

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yasuhiro Kodera
Organization	Graduate School of Medicine, Nagoya University
Division name	Department of Gastroenterological Surgery
Zip code
Address	65, Tsurumai-cho, Showa-ku, Nagoya, Aiti 466-8550, JAPAN
TEL	052-744-2250
Email	ykodera@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Chie TANAKA
Organization	Graduate School of Medicine, Nagoya University
Division name	Department of Gastroenterological Surgery
Zip code
Address	65, Tsurumai-cho, Showa-ku, Nagoya, Aiti 466-8550, JAPAN
TEL	052-744-2250
Homepage URL
Email	chtanaka@med.nagoya-u.ac.jp

Sponsor
Institute	Department of Gastroenterological Surgery, Graduate School of Medicine, Nagoya University
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	2013 Year 10 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	Open public recruiting
Date of protocol fixation	2013 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date	2013 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 08 Month 06 Day
Last modified on	2014 Year 12 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013340

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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