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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043758
Receipt No. R000049954
Scientific Title Disconnected pancreatic duct syndrome (DPDS) and treatment outcomes of pancreatic fluid collections: protocol of a meta-analysis
Date of disclosure of the study information 2021/03/30
Last modified on 2021/04/01

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Basic information
Public title Pancreatic duct disconnection and treatment outcomes of pancreatic fluid collections
Acronym Pancreatic duct disconnection and treatment outcomes
Scientific Title Disconnected pancreatic duct syndrome (DPDS) and treatment outcomes of pancreatic fluid collections: protocol of a meta-analysis
Scientific Title:Acronym Meta-analysis of treatment outcomes of DPDS
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 treatment outcomes of pancreatic fluid collections according to the presence of DPDS.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Recurrence of pancreatic fluid collection after successful treatment
Key secondary outcomes Technical success, clinical success, number of interventions, time to clinical success, length of stay, medical costs, adverse events, mortality, 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 "pancreatitis", "pancreatic pseudocyst", "walled-off necrosis", "disconnection", "disruption", and "pancreatic juice leak" with their word variations.
Key exclusion criteria We exclude studies reporting treatment outcomes only for surgical management of DPDS.
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
Email ynakai-tky@umin.ac.jp

Public contact
Name of contact person
1st name Tomotaka
Middle name
Last name Saito
Organization Graduate School of Medicine, The University of Tokyo
Division name Department of Gastroenterology
Zip code 113-8655
Address 7-3-1 Hongo, Bunkyo City, Tokyo
TEL 81-3-3815-5411
Homepage URL
Email tomsaito-gi@umin.ac.jp

Sponsor
Institute Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
Institute
Department

Funding Source
Organization Not applicable.
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 0
Email tomsaito-gi@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
2021 Year 03 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
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 Preinitiation
Date of protocol fixation
2021 Year 03 Month 26 Day
Date of IRB
Anticipated trial start date
2021 Year 03 Month 31 Day
Last follow-up date
2021 Year 03 Month 31 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 January 2021 with data comparing treatment outcomes of pancreatic fluid collections between DPDS and non-DPDS patients. We pool data on treatment outcomes using the random-effects model.

Management information
Registered date
2021 Year 03 Month 26 Day
Last modified on
2021 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049954

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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