UMIN-CTR Clinical Trial

Basic information
Public title	Impact of guidelines and clinical trials on the surgeon's decision
Acronym	Impact of guidelines and clinical trials on the surgeon's decision
Scientific Title	Impact of guidelines and clinical trials on the surgeon's decision
Scientific Title:Acronym	Impact of guidelines and clinical trials on the surgeon's decision
Region	Japan

Condition
Condition	Gastric cancer
Classification by specialty	Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	to investigate the impact of the results of Phase III clinical trials and the publication of guidelines on surgeons' surgical decisions and on surgical outcomes.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Percentage of laparoscopic gastrectomy performed per month Number of gastrectomy performed for Stage IV gastric cancer patients per month
Key secondary outcomes

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	Patients who underwent gastrectomy for Stage I gastric cancer Patients who underwent gastrectomy for Stage IV gastric cancer
Key exclusion criteria	Surgical procedure unknown Date of surgery unknown
Target sample size	10000

Research contact person
Name of lead principal investigator	1st name Michitaka Middle name Last name Honda
Organization	Fukushima Medical University
Division name	Minimally Invasive Surgical and Medical University
Zip code	960-1295
Address	Fukushima
TEL	0245471111
Email	mhonda@fukushimamed.com

Public contact
Name of contact person	1st name Michitaka Middle name Last name Honda
Organization	Fukushima Medical University
Division name	Minimally Invasive Surgical and Medical University
Zip code	9601295
Address	Fukushima
TEL	0245471111
Homepage URL
Email	mhonda@fukushimamed.com

Sponsor
Institute	Fukushima Medical University Minimally Invasive Surgical and Medical University
Institute
Department

Funding Source
Organization	Self funding
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	Fukushima medhical University
Address	Fukushima
Tel	0245471111
Email	mhonda@fukushimamed.com

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	2022 Year 08 Month 16 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	64910
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	2020 Year 07 Month 01 Day
Date of IRB	2020 Year 07 Month 27 Day
Anticipated trial start date	2021 Year 07 Month 01 Day
Last follow-up date	2022 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	DPC data were retrospectively analyze

Management information
Registered date	2022 Year 08 Month 16 Day
Last modified on	2022 Year 08 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055469