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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000027638 |
Receipt No. | R000031663 |
Scientific Title | Two Electrosurgical Mode for Endoscopic Submucosal Dissection of Colorectal Superficial Neoplasms: A Prospective Randomised Study |
Date of disclosure of the study information | 2017/07/01 |
Last modified on | 2020/11/06 |
Basic information | ||
Public title | Two Electrosurgical Mode for Endoscopic Submucosal Dissection of Colorectal Superficial Neoplasms: A Prospective Randomised Study | |
Acronym | Two Electrosurgical Mode for Colorectal ESD | |
Scientific Title | Two Electrosurgical Mode for Endoscopic Submucosal Dissection of Colorectal Superficial Neoplasms: A Prospective Randomised Study | |
Scientific Title:Acronym | Two Electrosurgical Mode for Colorectal ESD | |
Region |
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Condition | ||
Condition | Colorectal Superficial Neoplasms: | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | We compared the performances of the Endo-cut I mode and Swift-coagulation mode |
Basic objectives2 | Safety |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | procedure time required for submucosal dissection |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Placebo |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | performed ESD with Endo-cut I mode | |
Interventions/Control_2 | performed ESD with Swift-coagulation mode | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | (a)tumour diagnosed with colonoscopy before ESD
(b)lesions of 20-50 mm in diameter (c)colorectal intra-mucosal or minutes-invaded cancer (d)no lymph node or distant metastasis |
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Key exclusion criteria | (a) non-correctable coagulopathy
(b) severe organ failure (c) a comorbidity requiring continuous antithrombotic medication |
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Target sample size | 128 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Okayama University Graduate School of Medicine | ||||||
Division name | Division of Endoscopy | ||||||
Zip code | |||||||
Address | 2-5-1 Shikata-cho, Kita-ku, Okayama, Japan | ||||||
TEL | 086-235-7219 | ||||||
keita818@cc.okayama-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Okayama University Graduate School of Medicine | ||||||
Division name | general medicine | ||||||
Zip code | |||||||
Address | 2-5-1 Shikata-cho, Kita-ku, Okayama, Japan | ||||||
TEL | 086-235-7219 | ||||||
Homepage URL | |||||||
y.sugi117@gmail.com |
Sponsor | |
Institute | Division of Endoscopy
Okayama University Graduate School of Medicine |
Institute | |
Department |
Funding Source | |
Organization | none |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
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IRB Contact (For public release) | |
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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 |
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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 | |
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Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031663 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |