UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056525 |
|---|---|
| Receipt number | R000064574 |
| Scientific Title | A Single-Center Prospective Study on the Safety of Cold Snare Polypectomy (CSP) in Intensive Downstaging Polypectomy (IDP) for Multiple Colorectal Polyps in Familial Adenomatous Polyposis (FAP) |
| Date of disclosure of the study information | 2025/01/01 |
| Last modified on | 2025/06/20 17:03:03 |
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Basic information
Public title
A Single-Center Prospective Study on the Safety of Cold Snare Polypectomy (CSP) in Intensive Downstaging Polypectomy (IDP) for Multiple Colorectal Polyps in Familial Adenomatous Polyposis (FAP)
Acronym
A Single-Center Prospective Study on the Safety of Cold Snare Polypectomy (CSP) in Intensive Downstaging Polypectomy (IDP) for Multiple Colorectal Polyps in Familial Adenomatous Polyposis (FAP)
Scientific Title
A Single-Center Prospective Study on the Safety of Cold Snare Polypectomy (CSP) in Intensive Downstaging Polypectomy (IDP) for Multiple Colorectal Polyps in Familial Adenomatous Polyposis (FAP)
Scientific Title:Acronym
A Single-Center Prospective Study on the Safety of Cold Snare Polypectomy (CSP) in Intensive Downstaging Polypectomy (IDP) for Multiple Colorectal Polyps in Familial Adenomatous Polyposis (FAP)
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 Cold Snare Polypectomy (CSP) in Intensive Downstaging Polypectomy (IDP) for multiple colorectal polyps in Familial Adenomatous Polyposis (FAP)
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence rate of severe complications (post-procedural bleeding and gastrointestinal perforation)
Key secondary outcomes
All adverse events, the severity of abdominal pain on the day following the procedure, postoperative hematochezia, the need for emergency endoscopic intervention, and the occurrence of readmission
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
Inclusion Criteria:
1 Patients diagnosed with Familial Adenomatous Polyposis (FAP) who are undergoing or scheduled to undergo Intensive Downstaging Polypectomy (IDP).
2 Patients who have not undergone colectomy (excluding appendectomy) or those who have undergone surgery but have at least 10 cm of the colon remaining.
3 Patients aged between 18 and 80 years at the time of consent.
4 Patients with an ECOG Performance Status (PS) of 0 or 1.
5 Patients who have provided written informed consent for participation in the study.
Key exclusion criteria
Exclusion Criteria:
1 Presence of colorectal lesions >=10mm identified before endoscopic treatment.
2 Diagnosis of severe-type Familial Adenomatous Polyposis (FAP).
3 Pre-treatment blood tests showing a hemoglobin level <10 g/dL.
4 Presence of severe diseases in other organs.
5 Use of anticoagulants where management according to the latest guidelines of the Japan Gastroenterological Endoscopy Society is not feasible.
6 Ongoing systemic steroid therapy.
7 Undergoing chemotherapy.
8 Presence of an active infection.
9 Previous enrollment in this study.
10 Other cases deemed unsuitable for inclusion by the principal investigator or the responsible investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Minoru |
| Middle name | |
| Last name | Kato |
Organization
Osaka International Cancer Institute
Division name
Department of Gastrointestinal Oncology
Zip code
541-8567
Address
1-69, Otemae 3-chome, Chuo-ku, Osaka, Japan
TEL
+81-6-6945-1181
minoru.kato@oici.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Matsuyama |
Organization
Osaka International Cancer Institute
Division name
Department of Gastrointestinal Oncology
Zip code
541-8567
Address
1-69, Otemae 3-chome, Chuo-ku, Osaka, Japan
TEL
+81-6-6945-1181
Homepage URL
matsuyama.kazuki.kyotomed@gmail.com
Sponsor or person
Institute
Osaka International Cancer Institute
Institute
Department
Personal name
Funding Source
Organization
None
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
Osaka International Cancer Institute
Address
1-69, Otemae 3-chome, Chuo-ku, Osaka, Japan
Tel
+81-6-6945-1181
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
| 2025 | Year | 01 | Month | 01 | 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
| 2024 | Year | 11 | Month | 21 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Collected Data:
Patient Background: Age, gender, history of colorectal surgery, and pre-procedural blood test results.
Endoscopic Treatment Details: Date of procedure, endoscopist, number of lesions treated, maximum polyp size, presence of cancer, highest grade of dysplasia, treatment duration, intraoperative adverse events, pre-procedure preparation, etc.
Post-Treatment Course: Adverse events, blood test results on the day after treatment, spontaneous abdominal pain (NRS), tenderness in four abdominal areas (epigastric, umbilical, left, and right abdomen; NRS), presence of hematochezia, and readmission status.
Follow-Up Colonoscopy Findings: Number of polyps >= 10 mm.
Pre-procedural blood tests are defined as those performed within 7 months prior to the procedure date. Follow-up colonoscopy is defined as a colonoscopy performed within 6-18 months after the procedure.
The definition of post-procedural bleeding in this study includes cases where invasive hemostasis procedures (e.g., endoscopy, angiographic intervention, or surgery) were performed or where >= 2 units of packed red blood cells were transfused. Cases treated conservatively (e.g., fasting, fluid replacement, or hemostatic agents) for hematochezia are not included as post-procedural bleeding. Prophylactic hemostasis for non-active bleeding ulcers without Forrest classification I or IIa findings is also excluded from post-procedural bleeding.
Adverse events are evaluated for occurrences within 14 days post-procedure. However, events beyond 14 days are also considered if deemed clearly related to endoscopic treatment by the study investigator.
Management information
Registered date
| 2024 | Year | 12 | Month | 20 | Day |
Last modified on
| 2025 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064574
