UMIN-CTR Clinical Trial

Basic information
Public title	Endoscopic submucosal dissection appropriate interval observation study
Acronym	AI study
Scientific Title	Endoscopic submucosal dissection appropriate interval observation study
Scientific Title:Acronym	AI study
Region	Japan

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

Objectives
Narrative objectives1	After endoscopic submucosal dissection (ESD) for gastric cancer, to clarify the appropriate endoscopic test interval in order to discover the metachronous gastric cancer in endoscopic therapy adaptive.
Basic objectives2	Others
Basic objectives -Others	After early gastric cancer ESD, metachronous gastric cancer at a constant rate is for generating, regular endoscopy is performed. Usually, as surveillance of stomach cancer that occurs in metachronous, is often carried out every 12 months, it has been found beyond the endoscopic healing adaptation with 0-15% of metachronous gastric cancer. So we, the interval at which to implement the upper gastrointestinal endoscopy after ESD test for gastric cancer is assigned to 6 months and 12 months do the prospective study, found in the off-label of endoscopic therapy by reducing the inspection interval It is possible to reduce the frequency of occurrence of metachronous gastric cancer to examine whether it is possible that.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Occurrence rate of metachronous gastric cancer to be found beyond the endoscopic therapy adaptation
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	After endoscopic curative resection of gastric cancer, performed upper gastrointestinal endoscopy and every 6 months to 5 years.
Interventions/Control_2	After endoscopic curative resection of gastric cancer, performed upper gastrointestinal endoscopy and every 12 months to 5 years.
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	Patients who have been determined to curative resection with endoscopic therapy for the initial of early gastric cancer (adenocarcinoma).
Key exclusion criteria	Patients who have received a treatment of gastric cancer in the past. In addition to endoscopic resection healing lesions, patients with different tumor lesions. Patients with gastric adenoma. Patients with surgical esophagus and stomach resection history. Others, patients principal investigator and research personnel was judged to be inappropriate as a target.
Target sample size	1500

Research contact person
Name of lead principal investigator	1st name Shuichi Middle name Last name Kaneko
Organization	Kanazawa University
Division name	Department of gastroenterology
Zip code	920-8641
Address	13-1,Takaramachi,Kanazawa
TEL	076-265-2235
Email	skaneko@m-kanazawa.jp

Public contact
Name of contact person	1st name Hajime Middle name Last name Takatori
Organization	Kanazawa University
Division name	Department of gastroenterology
Zip code	920-8641
Address	13-1, Takara-machi, Kanazawa
TEL	076-265-2235
Homepage URL
Email	takatori@m-kanazawa.jp

Sponsor
Institute	Hokuriku branch of Japan Gastroenterological Endoscopy Society
Institute
Department

Funding Source
Organization	Hokuriku Branch of Japan Gastroenterological Endoscopy Society
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	iCREK
Address	13-1, Takara-machi, Kanazawa
Tel	076-265-2090
Email	crc.irb-knz@esct.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	金沢大学附属病院、金沢医科大学病院、石川県立中央病院、公立松任石川中央病院、市立砺波総合病院、福井県立病院、金沢医療センター、富山県立中央病院、小松市民病院、福井県済生会病院、やわたメディカルセンター、恵寿総合病院、富山市民病院、公立能登総合病院、公立羽咋病院、市立敦賀病院、金沢市立病院、金沢赤十字病院、福井赤十字病院、済生会金沢病院、浅ノ川病院

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 29 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	Enrolling by invitation
Date of protocol fixation	2016 Year 08 Month 26 Day
Date of IRB	2016 Year 07 Month 28 Day
Anticipated trial start date	2016 Year 10 Month 01 Day
Last follow-up date	2026 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 08 Month 29 Day
Last modified on	2019 Year 09 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027156