UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035145 |
|---|---|
| Receipt number | R000040052 |
| Scientific Title | 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 | 2023/01/04 17:09:22 |
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Basic information
Public title
Local Recurrence after Endoscopic Resection for Sessile serrated polyp: A Multicenter Prospective Study by the Osaka Gut Forum
Acronym
Local Recurrence after Endoscopic Resection for SSP
Scientific Title
Local Recurrence after Endoscopic Resection for Sessile serrated polyp: A Multicenter Prospective Study by the Osaka Gut Forum
Scientific Title:Acronym
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
| 1st name | Tetsuo |
| Middle name | |
| Last name | Takehara |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
5650871
Address
2-2 Yamadaoka Suita, Osaka,Japan.
TEL
06-6879-3621
takehara@gh.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoki |
| Middle name | |
| Last name | Shichijo |
Organization
Osaka International Cancer Institute
Division name
Department of Gastrointestinal Oncology
Zip code
5418567
Address
3-1-69, Otemae, Chuo-ku, Osaka
TEL
06-6945-1181
Homepage URL
sitijyo-sa@mc.pref.osaka.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Osaka, Japan
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Review board, Osaka University
Address
2-2, Yamadaoka, Suita-shi, Osaka
Tel
06-6210-8296
handai-nintei@hp-crc.med.osaka-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 05 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1111/jgh.16032
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/jgh.16032
Number of participants that the trial has enrolled
105
Results
The cases of local recurrence were identified.
Results date posted
| 2023 | Year | 01 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This prospective, single-arm, observational study was performed at eight Japanese tertiary institutions. Colorectal lesions >=10 mm were resected endoscopically, and the pathological diagnosis was either an SSL or hyperplastic polyp (HP). Follow-up colonoscopy was performed 1 year later, and the local recurrence was evaluated by biopsy.
Participant flow
Those patients who resected polyps >=10mm, pathologically diagnosed either as SSL or HP were recruited.
Adverse events
Two post EMR bleedings were managed by endoscopy.
Outcome measures
Among the 95 patients with 113 lesions who underwent follow-up colonoscopy, resection scars were identified in 95 (84%) lesions. Three (3.1%; 95% confidence interval 0.6-8.7%) local recurrences were diagnosed pathologically among 98 pathologically diagnosed SSLs.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
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
| 2023 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040052
