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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044130
Receipt No. R000050320
Scientific Title A multicenter clinical study on walled-off necrosis and peripancreatic fluid collection after acute pancreatitis
Date of disclosure of the study information 2021/05/07
Last modified on 2021/05/07

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Basic information
Public title A multicenter clinical study on walled-off necrosis and peripancreatic fluid collection after acute pancreatitis
Acronym WONDERFUL (WON anD pERipancreatic FlUid coLlection) study
Scientific Title A multicenter clinical study on walled-off necrosis and peripancreatic fluid collection after acute pancreatitis
Scientific Title:Acronym WONDERFUL (WON anD pERipancreatic FlUid coLlection) study
Region
Japan

Condition
Condition Patients who were diagnosed as local complications of acute pancreatitis and were treated by conservative management or non-surgical and/or surgical interventions. Local complications are classified into four types according to the revised Atlanta classification; acute peripancreatic fluid collection (APFC) and acute necrotic collection (ANC) occurring within 4 weeks of the onset of acute pancreatitis, and pancreatic pseudocyst (PPC) and walled-off necrosis (WON) occurring after 4 weeks of the onset of acute pancreatitis.
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Emergency medicine
Intensive care medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate clinical features and treatment outcomes of local complications of acute pancreatitis by establishing a large multicenter cohort of patients with pancreatic fluid collection
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Clinical success
Key secondary outcomes Interventions including procedure time and duration, technical success, adverse events, costs, recurrence, long-term outcomes, prognosis, association of concomitant medications with clinical 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 were diagnosed with local complications of acute pancreatitis and needed treatment including conservative management and non-surgical and/or surgical interventions between 01/01/2010 and 11/30/2020.
Key exclusion criteria Patients who did not want to be included in the study.
Target sample size 600

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-ku, Tokyo, JAPAN
TEL 03-3815-5411
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-ku, Tokyo, JAPAN
TEL 03-3815-5411
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 None
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 Graduate School of Medicine, The University of Tokyo, Office for Human Research Studies
Address 7-3-1, Hongo Bunkyo-ku, Tokyo, JAPAN
Tel 03-3815-5411
Email ethics@m.u-tokyo.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 東京大学医学部附属病院(東京都)、富山大学附属病院(富山県)、岐阜大学医学部附属病院(岐阜県)、神戸大学医学部附属病院(兵庫県)、近畿大学医学部附属病院(大阪府)、兵庫医科大学病院(兵庫県)、順天堂大学医学部附属順天堂医院(東京都)、金沢医科大学病院(石川県)、岐阜県総合医療センター(岐阜県)、岐阜市民病院(岐阜県)、埼玉医科大学総合医療センター(埼玉県)。今後参加施設は増やしていく予定である。

Other administrative information
Date of disclosure of the study information
2021 Year 05 Month 07 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
2020 Year 12 Month 22 Day
Date of IRB
2021 Year 02 Month 08 Day
Anticipated trial start date
2021 Year 02 Month 09 Day
Last follow-up date
2025 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study are conducted by the WONDERFUL (WON anD pERipancreatic FlUid coLlection) study group, which consists of endoscopists, gastroenterologists, interventional radiologists, and epidemiologists at high-volume centers in Japan.

Management information
Registered date
2021 Year 05 Month 07 Day
Last modified on
2021 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050320

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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