UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023804 |
|---|---|
| Receipt number | R000027156 |
| Scientific Title | Endoscopic submucosal dissection appropriate interval observation study |
| Date of disclosure of the study information | 2016/08/29 |
| Last modified on | 2019/09/02 08:38:16 |
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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
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
takatori@m-kanazawa.jp
Sponsor or person
Institute
Hokuriku branch of Japan Gastroenterological Endoscopy Society
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027156
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