UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051301 |
|---|---|
| Receipt number | R000058516 |
| Scientific Title | Observational study on the safety and usefulness of a novel hemostatic agent for endoscopic sphincterotomy |
| Date of disclosure of the study information | 2023/06/12 |
| Last modified on | 2023/12/11 20:45:15 |
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Basic information
Public title
Observational study on the safety and usefulness of a novel hemostatic agent for endoscopic sphincterotomy
Acronym
Observational study on the safety and usefulness of a novel hemostatic agent for endoscopic sphincterotomy
Scientific Title
Observational study on the safety and usefulness of a novel hemostatic agent for endoscopic sphincterotomy
Scientific Title:Acronym
Observational study on the safety and usefulness of a novel hemostatic agent for endoscopic sphincterotomy
Region
| Japan |
Condition
Condition
obstructive jaundice
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the safety and usefulness of a novel hemostatic agent, PuraStat, for endoscopic sphincterotomy-related hemorrhage.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of post EST bleeding
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
Patients who meet all of the following criteria
1. Patients who require biliary drainage for treatment of common bile duct stones, cholangitis, and obstructive jaundice, etc. based on various diagnostic imaging studies.
2. Patients must be at least 20 years old and have good ADL (ECOG performance status 0-1). 3.
3. Informed consent in the study has been obtained from the patient or the patient's surrogate
Key exclusion criteria
Patients with any of the following conditions will not be included in this study
1. Patients with a history of endoscopic sphincterotomy or endoscopic papillectomy
2. Patients with duodenal stenosis.
3. Patients who are scheduled for endoscopic papillectomy
4. Patients deemed inappropriate for the study by the investigator.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Ishida |
Organization
Fukuoka University, Faculty of Medicine
Division name
Department of Gastroenterology and Medicine
Zip code
814-0180
Address
7-45-1 Nanakuma, Johnan-ku, Fukuoka, Japan
TEL
+81-92-801-1011
y.ishida.cb@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Ishida |
Organization
Fukuoka University, Faculty of Medicine
Division name
Department of Gastroenterology and Medicine
Zip code
814-0180
Address
7-45-1 Nanakuma, Johnan-ku, Fukuoka, Japan
TEL
+81-92-801-1011
Homepage URL
y.ishida.cb@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University
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
Medical Ethics Committee of Fukuoka University
Address
7-45-1 Nanakuma, Johnan-ku, Fukuoka, Japan
Tel
+81-92-801-1011
fumed-ethics@fukuoka-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
| 2023 | Year | 06 | Month | 12 | 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
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
EST is performed as usual, and if bleeding occurs following EST, PureStat is applied endoscopically to the incision site using a catheter. PureStat should be added until hemostasis is confirmed endoscopically. If hemostasis is not achieved with PureStat application, other hemostatic methods such as balloon tamponade may be used, but there are no restrictions on these methods. One week after the completion of the procedure will be used as the observation period to check for adverse events such as re-bleeding. In patients who have given consent to participate in the study and who did not bleed during EST, their data will only be collected as a control group.
Management information
Registered date
| 2023 | Year | 06 | Month | 08 | Day |
Last modified on
| 2023 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058516
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
