UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046432 |
|---|---|
| Receipt number | R000052981 |
| Scientific Title | Self-assembling peptide for local hemostasis during Endoscopic Treatment of Duodenum: A Observation Study |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2024/05/20 11:14:04 |
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Basic information
Public title
Self-assembling peptide for local hemostasis during Endoscopic Treatment of Duodenum: A Observation Study
Acronym
Self-assembling peptide for local hemostasis during Endoscopic Treatment of Duodenum: A Observation Study
Scientific Title
Self-assembling peptide for local hemostasis during Endoscopic Treatment of Duodenum: A Observation Study
Scientific Title:Acronym
SAMPLE study
Region
| Japan |
Condition
Condition
Non-papillary superficial duodenal tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To conduct an observational study on the efficacy of Self-assembling peptide for bleeding during endoscopic treatment of the duodenum and to evaluate the rate of hemostasis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hemostasis rate of bleeding during duodenal CSP and ESD using Self-assembling peptide
Key secondary outcomes
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)The patient has a lesion diagnosed as a superficial tumor (adenoma or intramucosal carcinoma) of the non-papillary part of the duodenum by endoscopy and is scheduled for CSP or ESD.
(2) The lesion is located in the bulb, descending part, or horizontal part of the duodenum, and there is no continuity with the papilla.
(3) In case of multiple lesions, the maximum number of lesions to be treated is 10.
(4) The patient's age at the time of enrollment should be 20 years or older.
(5) The patient has been fully informed about the participation in the study and has given his/her consent.
Key exclusion criteria
(1) In accordance with the "Guidelines for Gastrointestinal Endoscopy for Patients Taking Antithrombotic Drugs (2017 Supplement on Anticoagulants)", temporary discontinuation of antithrombotic medication is not possible and endoscopic treatment cannot be performed (discontinuation of medication is not mandatory if endoscopic treatment is possible).
(2) Patients with infections that require systemic treatment
(3) Pregnant or lactating women
(4) Patients for whom follow-up after 4 weeks is not possible
(5) Patients who are judged inappropriate by the investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Dohi |
Organization
Kyoto Prefectural University of Medicine
Division name
Gastroenterology
Zip code
602-8566
Address
465 Kajii-cho, Kamigyo-ku, Kyoto-city, Kyoto
TEL
075-251-5519
osamu-d@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Osamu |
| Middle name | |
| Last name | Dohi |
Organization
Kyoto Prefectural University of Medicine
Division name
Gastroenterology
Zip code
602-8566
Address
465 Kajii-cho, Kamigyo-ku, Kyoto-city, Kyoto
TEL
075-251-5519
Homepage URL
osamu-d@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Institutional Review Board of Kyoto Prefectural University of Medicine
Address
465 Kajii-cho, Kamigyo-ku, Kyoto-city, Kyoto
Tel
075-251-5537
rinri@koto.kpu-m.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
| 2022 | Year | 04 | 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
25
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
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To conduct an observational study on the efficacy of Self-assembling peptide for bleeding during endoscopic treatment of the duodenum and to evaluate the rate of hemostasis.
Management information
Registered date
| 2021 | Year | 12 | Month | 21 | Day |
Last modified on
| 2024 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052981
