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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000015956
Receipt No. R000018564
Scientific Title A prospective feasibility study of laparoscopic and endoscopic cooperative surgery for gastric cancer
Date of disclosure of the study information 2015/12/01
Last modified on 2015/12/15

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Basic information
Public title A prospective feasibility study of laparoscopic and endoscopic cooperative surgery for gastric cancer
Acronym A prospective feasibility study of laparoscopic and endoscopic cooperative surgery for gastric cancer
Scientific Title A prospective feasibility study of laparoscopic and endoscopic cooperative surgery for gastric cancer
Scientific Title:Acronym A prospective feasibility study of laparoscopic and endoscopic cooperative surgery for gastric cancer
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the safety of laparoscopic and endoscopic cooperative surgery for gastric cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes postoperative complications
Key secondary outcomes recurrence rate, operation time, postoperative hospital stay, postoperative quality of life

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 laparoscopic and endoscopic cooperative surgery
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Histologically proven gastric adenocarcinoma.
2) Indication of local resection of stomach for early gastric cancer.
3) Written informed consent.
Key exclusion criteria 11) Synchronous or metachronous malignancies other than carcinoma in situ.
2) Infectious disease with systemic therapy indicated.
3) Severe mental disease.
Target sample size 96

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michitaka Fujiwara
Organization Nagoya University Graduate School of Medicine
Division name Nagoya University Clinical Simulation Center
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL 052-744-2245
Email mfuji@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, Aichi, Japan
TEL 052-744-2250
Homepage URL
Email chtanaka@med.nagoya-u.ac.jp

Sponsor
Institute Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization none
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
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
2015 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 Preinitiation
Date of protocol fixation
2016 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 07 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
2014 Year 12 Month 15 Day
Last modified on
2015 Year 12 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018564

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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