UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049891 |
|---|---|
| Receipt number | R000056823 |
| Scientific Title | Early vs. delayed interventions for postoperative pancreatic fistula: Protocol of a meta-analysis |
| Date of disclosure of the study information | 2023/01/01 |
| Last modified on | 2023/12/24 11:19:54 |
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Basic information
Public title
Timing of endoscopic interventions and treatment outcomes of postoperative pancreatic fistula
Acronym
Timing of endoscopic interventions and treatment outcomes of postoperative pancreatic fistula
Scientific Title
Early vs. delayed interventions for postoperative pancreatic fistula: Protocol of a meta-analysis
Scientific Title:Acronym
Meta-analysis of early vs. delayed endoscopic interventions for postoperative pancreatic fistula
Region
| Japan |
Condition
Condition
Postoperative pancreatic fistula
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate treatment outcomes of postoperative pancreatic fistula according to the timing of endoscopic interventions
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
adverse events
Key secondary outcomes
Technical success, clinical success, number and types of interventions, time to clinical success, length of stay, medical costs, mortality, recurrence, and others.
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 fistula" "fluid collection", "postoperative", "postsurgical", "pancreatectomy", "pancreatic surgery",""endoscopy", "endoscopic", "EUS", "drainage", "stent", "management" with their word variations.
Key exclusion criteria
We exclude studies reporting treatment outcomes only for pancreatic fluid collection after acute pancreatitis
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Yousuke |
| Middle name | |
| Last name | Nakai |
Organization
The University of Tokyo Hospital
Division name
Department of Endoscopy and Endoscopic Surgery
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo City, Tokyo
TEL
81-3-3815-5411
ynakai-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Tomotaka |
| Middle name | |
| Last name | Saito |
Organization
The University of Tokyo Hospital
Division name
Department of Gastroenterology
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo City, Tokyo
TEL
81-3-3815-5411
Homepage URL
tomsaito-gi@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
N/A
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
N/A
Address
N/A
Tel
N/A
ynakai-tky@umin.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 | 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
Main results already published
Date of protocol fixation
| 2023 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Through electrical search of the literature, we identify studies published until December 2022 with data on treatment outcomes of ppost operative pancreatic fistula according to the timing of interventions. We pool data on treatment outcomes using the random-effects model.
Management information
Registered date
| 2022 | Year | 12 | Month | 24 | Day |
Last modified on
| 2023 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056823
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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