UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051414 |
|---|---|
| Receipt number | R000058527 |
| Scientific Title | Safety of intensive downstaging polypectomy (IDP) with low power pure-cut current (LPPC) in patients with familial adenomatous polyposis (FAP) |
| Date of disclosure of the study information | 2023/06/23 |
| Last modified on | 2023/06/29 17:03:58 |
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Basic information
Public title
Safety of intensive downstaging polypectomy with low power pure-cut current in patients with familial adenomatous polyposis
Acronym
Safety of intensive downstaging polypectomy with low power pure-cut current in patients with familial adenomatous polyposis
Scientific Title
Safety of intensive downstaging polypectomy (IDP) with low power pure-cut current (LPPC) in patients with familial adenomatous polyposis (FAP)
Scientific Title:Acronym
Safety of intensive downstaging polypectomy with low power pure-cut current in patients with familial adenomatous polyposis
Region
| Japan |
Condition
Condition
Familial adenomatous polyposis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the safety of intensive downstaging polypectomy with low power pure-cut current in patients with familial adenomatous polyposis
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Incidence of severe adverse events (delayed bleeding and perforation)
Key secondary outcomes
adverse events related to IDP, procedure time, degree of abdominal pain on the day following IDP, presence of hematochezia after IDP, emergency colonoscopy and readmission to the hospital
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed with familial adenomatous polyposis and undergoing or scheduled to undergo IDP
2) Those who have not undergo colectomy, or those who had undergone colectomy and had 10 cm or more of large intestine remaining
3) Patients aged 18 to 80 years old
4) Patients with ECOG PS 0 or 1
5) Patients with written informed consent
Key exclusion criteria
1) Patients known to have colorectal lesion larger than 15 mm
2) Those who had dense polyps
3) Patients with serious other organ disease
4) Patients continuing antithrombotic drugs, for whom IDP should not be carried out according to the Japanese guidelines
5) Patients continuing systemic administration of steroid
6) Patients receiving anticancer agents
7) Those who have psychosis or psychiatric symptoms that would make participation in the study difficult
8) Patients with active infection disease
9) Patients deemed by the investigator to be inappropriate to participate
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Satoki |
| Middle name | |
| Last name | Shichijo |
Organization
Osaka International Cancer Institute
Division name
Department of Gastrointestinal Oncology
Zip code
541-8567
Address
3-1-69 Otemae, Chuo-ku, Osaka 541-8567, Japan
TEL
06-6945-1181
7satoki@gmail.com
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Tani |
Organization
Osaka International Cancer Institute
Division name
Department of Gastrointestinal Oncology
Zip code
541-8567
Address
3-1-69 Otemae, Chuo-ku, Osaka 541-8567, Japan
TEL
06-6945-1181
Homepage URL
y.tani1646@gmail.com
Sponsor or person
Institute
Department of Gastrointestinal Oncology, Osaka International Cancer Institute
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Osaka International Cancer Institute
Address
3-1-69 Otemae, Chuo-ku, Osaka 541-8567, Japan
Tel
06-6945-1181
rinri01@opho.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
| 2023 | Year | 06 | Month | 23 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center, prospective, observational study.
Included patients are diagnosed with familial adenomatous polyposis and undergoing or scheduled to undergo intensive downstaging polypectomy between June 2023 and June 2024.
Management information
Registered date
| 2023 | Year | 06 | Month | 22 | Day |
Last modified on
| 2023 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058527
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| Registered date | File name |
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| Registered date | File name |
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