UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051446 |
|---|---|
| Receipt number | R000058673 |
| Scientific Title | A multicenter clinical study on local complications after acute pancreatitis and surgical resection |
| Date of disclosure of the study information | 2023/06/27 |
| Last modified on | 2023/06/26 07:52:55 |
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Basic information
Public title
A multicenter clinical study on local complications after acute pancreatitis and surgical resection
Acronym
WONDERFUL (WON anD pERipancreatic FlUid coLlection) study
Scientific Title
A multicenter clinical study on local complications after acute pancreatitis and surgical resection
Scientific Title:Acronym
WONDERFUL (WON anD pERipancreatic FlUid coLlection) study
Region
| Japan |
Condition
Condition
Patients who were diagnosed as local complications of acute pancreatitis or postoperative pancreatic fistula (POPF) and were treated by conservative management or non-surgical and/or surgical interventions. Local complications of acute pancreatitis 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. POPF are classified into three types; pancreatic fluid collection (PFC), internal pancreatic fistula (IPF) and external pancreatic fistula (EPF).
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 and surgical resection by establishing a large multicenter cohort.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who were diagnosed with local complications of acute pancreatitis or surgical resection and needed treatment including conservative management and non-surgical and/or surgical interventions between 01/01/2006 and 4/30/2023.
Key exclusion criteria
Patients who did not want to be included in the study.
Target sample size
1500
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
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
tomsaito-gi@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Yousuke Nakai
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
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）、がん研究会有明病院（東京都）、国立がん研究センター中央病院（東京都）、静岡県立静岡がんセンター（静岡県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 27 | 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
423
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
| 2023 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 02 | Day |
Last follow-up date
| 2028 | Year | 04 | 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
| 2023 | Year | 06 | Month | 26 | Day |
Last modified on
| 2023 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058673
