UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of outcomes between robotic and conventional (laparoscopic and open) gastrectomy
Acronym	Comparison of results between robotic and conventional gastrectomy
Scientific Title	Comparison of outcomes between robotic and conventional (laparoscopic and open) gastrectomy
Scientific Title:Acronym	Comparison of results between robotic and conventional gastrectomy
Region	Japan

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

Objectives
Narrative objectives1	Robotic gastrectomy (RG) has been incereased in recent years, but a different method of dissection than conventional laparoscopic gastrectomy (LG) and open gastrectomy (OG) is the suprarenal pancreatic lymph node dissection. We will compare the short-term results of RG and LG,OG.
Basic objectives2	Others
Basic objectives -Others	In addition to a retrospective review of the short-term results of RG and LG/OG, the number of lymph node dissections will be compared by site.
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase IV

Assessment
Primary outcomes	Comparison of the number of lymph node dissection between RG and LG/OG
Key secondary outcomes	Comparison of surgical outcomes (operative time, blood loss, postoperative complications, etc.) and number of lymph node dissections between RG and LG/OG by site

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) Histologically diagnosed with gastric cancer. (3) Resectability of RO
Key exclusion criteria	(1) Patients who are unable to give consent for the study.
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Sachiko Middle name Last name Kaida
Organization	Shiga University of Medical Science
Division name	Department of Surgery
Zip code	520-2192
Address	Tsukinowa-cho, Seta, Otsu, Shiga
TEL	077-548-2238
Email	kaida@belle.shiga-med.ac.jp

Public contact
Name of contact person	1st name Sachiko Middle name Last name Kaida
Organization	Shiga University of Medical Science
Division name	Department of Surgery
Zip code	520-2192
Address	Tsukinowa-cho, Seta, Otsu, Shiga
TEL	077-548-2238
Homepage URL
Email	kaida@belle.shiga-med.ac.jp

Sponsor
Institute	Department of Surgery, Shiga University of Medical Science
Institute
Department

Funding Source
Organization	Department of Surgery, Shiga University of Medical Science
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Shiga University of Medical Science
Address	Tsukinowa-cho, Seta, Otsu, Shiga
Tel	077-548-2238
Email	kaida@belle.shiga-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	滋賀医科大学　医学部附属病院

Other administrative information
Date of disclosure of the study information	2020 Year 09 Month 25 Day

Related information
URL releasing protocol	http://www.shiga-med.ac.jp/~hqsurge1/pg288.html
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	2017 Year 11 Month 20 Day
Date of IRB	2018 Year 11 Month 20 Day
Anticipated trial start date	2017 Year 12 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry	2023 Year 06 Month 30 Day
Date trial data considered complete	2023 Year 06 Month 30 Day
Date analysis concluded	2023 Year 09 Month 30 Day

Other

Other related information

An observational study using existing materials. The following information will be collected. 1) Preoperative patient status (gender, age, weight, BMI, preoperative complications, clinical stage, etc.) 2) Surgical results (blood loss, surgical time, number of dissected lymph nodes, length of stay, etc.) 3) Postoperative course (postoperative stage, short-term complications, postoperative nutritional status, etc.)

Management information
Registered date	2020 Year 09 Month 22 Day
Last modified on	2020 Year 09 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047785