UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052706 |
|---|---|
| Receipt number | R000060069 |
| Scientific Title | Further complete clearance of main pancreatic duct stones using basket catheter |
| Date of disclosure of the study information | 2023/11/06 |
| Last modified on | 2023/11/06 16:46:39 |
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Basic information
Public title
Further complete clearance of main pancreatic duct stones using basket catheter
Acronym
Main pancreatic duct stones extraction using basket catheter
Scientific Title
Further complete clearance of main pancreatic duct stones using basket catheter
Scientific Title:Acronym
Main pancreatic duct stones extraction using basket catheter
Region
| Japan |
Condition
Condition
Main pancreatic duct stones
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Usefulness of biliary basket for residual/micro pancreatic duct stone extraction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome is the evaluation of technical success rate.
Key secondary outcomes
The secondary outcome was evaluation of symptom improvement after stone extraction and therapeutic details of stone extraction.
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
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with/without previous therapy including ERCP/EHL/ESWL and having suspected residual/micro stones because of their abdominal symptoms, mainly pain and CT examination after that were eligible.
Key exclusion criteria
Patients who underwent repeated pancreatic stent exchange due to severe MPD stenosis were excluded.
Target sample size
7
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Sagami |
Organization
Oita San-ai Medical Center
Division name
Department of Gastroenterology
Zip code
8701151
Address
1213 Ichi, Oita
TEL
0975411311
sagami1985@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Sagami |
Organization
Oita San-ai Medical Center
Division name
Department of Gastroenterology
Zip code
8701151
Address
1213 Ichi, Oita
TEL
0975411311
Homepage URL
sagami1985@yahoo.co.jp
Sponsor or person
Institute
Oita San-ai Medical Center
Institute
Department
Personal name
Ryota Sagami
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Oita San-ai Medical Center
Address
1213 Ichi, Oita
Tel
0975411311
sagami1985@yahoo.co.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 | 11 | Month | 06 | 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 | 10 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Technical success was defined as achievement of residual/micro stone extraction using 8-wire basket. Improvement of symptoms and concerned stone clearance on pacreatography/CT were also evaluated with follow-up period. Procedure related adverse event was evaluated according to the consensus guideline. The primary outcome is the evaluation of technical success rate. The secondary outcome was evaluation of symptom improvement after final 8-wire stone extraction and therapeutic details of 8-wire stone extraction.
Management information
Registered date
| 2023 | Year | 11 | Month | 06 | Day |
Last modified on
| 2023 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060069
