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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035145
Receipt No. R000040052
Official scientific title of the study Local Recurrence after Endoscopic Resection for Sessile serrated polyp: A Multicenter Prospective Study by the Osaka Gut Forum
Date of disclosure of the study information 2018/12/05
Last modified on 2018/12/05

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Basic information
Official scientific title of the study Local Recurrence after Endoscopic Resection for Sessile serrated polyp: A Multicenter Prospective Study by the Osaka Gut Forum
Title of the study (Brief title) Local Recurrence after Endoscopic Resection for SSP
Region
Japan

Condition
Condition Sessile serrated polyp(SSP)
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine local recurrence rate after endoscopic resection for sessile serrated polyp
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Local Recurrence Rate after Endoscopic Resection for Sessile serrated polyp
Key secondary outcomes Local Recurrence Rate after Endoscopic Resection for hyperplastic polyp
Association between endoscopic and pathological diagnosis in each facility, and central pathological review
En bloc resection rate
Pathological negative resection margin rate
Adverse events rate

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) Colonic polyp equal to or larger than 10mm was resected endoscopically, and diagnosed SSP or hyperplastic polyp pathologically.
2) Informed consent was obtained from the patient.
Key exclusion criteria 1) The lesion is adjacent to post treatment scar.
2) Inflammatory bowel disease, familial adenomatous polyposis, Lynch syndrome, or Serrated polyposis syndrome
3) Mental disorder
Target sample size 124

Research contact person
Name of lead principal investigator Tetsuo Takehara
Organization Osaka University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Address 2-2 Yamadaoka Suita, Osaka,Japan.
TEL 06-6879-3621
Email takehara@gh.med.osaka-u.ac.jp

Public contact
Name of contact person Satoki Shichijo
Organization Osaka International Cancer Institute
Division name Department of Gastrointestinal Oncology
Address 3-1-69, Otemae, Chuo-ku, Osaka
TEL 06-6945-1181
Homepage URL
Email sitijyo-sa@mc.pref.osaka.jp

Sponsor
Institute Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Osaka, Japan
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

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
2018 Year 12 Month 05 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 09 Month 26 Day
Anticipated trial start date
2018 Year 09 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information To diagnose local recurrence, we perform colonoscopy one year after endoscopic resection.

Management information
Registered date
2018 Year 12 Month 05 Day
Last modified on
2018 Year 12 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040052

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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