UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050959 |
|---|---|
| Receipt number | R000058086 |
| Scientific Title | Long-term transmural plastic stent placement versus stent-free after successful endoscopic transmural management of peripancreatic fluid collections: A systematic review and meta-analysis |
| Date of disclosure of the study information | 2023/04/30 |
| Last modified on | 2023/04/28 21:04:48 |
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Basic information
Public title
Long-term transmural plastic stent placement versus stent-free after successful endoscopic transmural management of peripancreatic fluid collections
Acronym
Long-term transmural plastic stent placement versus stent-free after successful treatment
Scientific Title
Long-term transmural plastic stent placement versus stent-free after successful endoscopic transmural management of peripancreatic fluid collections: A systematic review and meta-analysis
Scientific Title:Acronym
Meta-analysis of Long-term transmural plastic stent placement versus stent-free after successful treatment
Region
| Japan |
Condition
Condition
Pancreatic fluid collections
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy of long-term transmural plastic stent placement versus stent-free after successful endoscopic transmural management of peripancreatic fluid collections
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A recurrence rate of pancreatic fluid collections
Key secondary outcomes
Adverse events
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The search terms include ("pancreatic fluid collection" or "walled-off necrosis" or "pseudocyst" or "pancreatic necrosis" or "necrotizing pancreatitis") AND ("endoscopy" or "endoscopic ultrasound" or "endoscopic ultrasonography" or "endosonography") AND ("stent" or "drainage")
Key exclusion criteria
No exclusion criteria
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Takuji |
| Middle name | |
| Last name | Iwashita |
Organization
Gifu University Hospital
Division name
First Department of Internal Medicine
Zip code
501-1194
Address
1-1 Yanagido, Gifu, Japan
TEL
058-230-6308
takuji@w7.dion.ne.jp
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Uemura |
Organization
Gifu University Hospital
Division name
First Department of Internal Medicine
Zip code
501-1194
Address
1-1 Yanagido, Gifu, Japan
TEL
058-230-6308
Homepage URL
ueshin550621@gmail.com
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
Takuji Iwashita
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
Not applicable
Address
Not applicable
Tel
Not applicable
Not applicable
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 | 04 | Month | 30 | 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
586
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 12 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 31 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Long-term transmural plastic stent placement versus stent-free were compared after successful endoscopic transmural management of peripancreatic fluid collections with a meta-analysis.
Management information
Registered date
| 2023 | Year | 04 | Month | 28 | Day |
Last modified on
| 2023 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058086
