UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062276 |
|---|---|
| Receipt number | R000071266 |
| Scientific Title | A multicenter prospective registry-based observational study of the clinical characteristics and treatment outcomes of thoracoabdominal complications associated with acute pancreatitis, including acute exacerbation of chronic pancreatitis, and surgical procedures |
| Date of disclosure of the study information | 2026/07/20 |
| Last modified on | 2026/07/18 21:19:36 |
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Basic information
Public title
A multicenter prospective registry study of the clinical features and treatment outcomes of thoracoabdominal complications associated with acute pancreatitis and surgical procedures
Acronym
WONDERFUL (WON anD pERipancreatic FlUid coLlection) study
Scientific Title
A multicenter prospective registry-based observational study of the clinical characteristics and treatment outcomes of thoracoabdominal complications associated with acute pancreatitis, including acute exacerbation of chronic pancreatitis, and surgical procedures
Scientific Title:Acronym
WONDERFUL (WON anD pERipancreatic FlUid coLlection) study
Region
| Japan |
Condition
Condition
Thoracoabdominal local complications associated with acute pancreatitis, including acute exacerbation of chronic pancreatitis, or surgical procedures. These include acute peripancreatic fluid collection (APFC), acute necrotic collection (ANC), pancreatic pseudocyst (PPC), and walled-off necrosis (WON) according to the revised Atlanta classification, as well as pleural effusion, ascites, and fluid collections or abscesses remote from the pancreas.
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 establish a large multicenter prospective registry cohort and comprehensively clarify the clinical characteristics and treatment outcomes of thoracoabdominal complications associated with acute pancreatitis and surgical procedures.
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
Treatment strategies, time to treatment, procedure time and treatment duration, number of procedures, technical success, need for step-up treatment, adverse events, length of hospital stay, medical costs, recurrence, reintervention, long-term outcomes and prognosis, and associations of patient factors, treatment factors, imaging findings, pancreatic duct findings, and microbiological findings 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
1. Patients with thoracoabdominal local complications associated with acute pancreatitis, including acute exacerbation of chronic pancreatitis, or surgical procedures, who receive routine clinical care.
2. Patients aged 18 years or older, irrespective of sex.
3. Outpatients or inpatients managed by the participating departments, including co-managed cases.
Patients referred after resolution of the acute inflammatory phase with persistent local complications are also eligible.
Key exclusion criteria
Patients considered inappropriate for inclusion by the treating physician.
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Naminatsu |
| Middle name | |
| Last name | Takahara |
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 113-8655, Japan
TEL
03-3815-5411
takaharan-int@h.u-tokyo.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 113-8655, Japan
TEL
03-3815-5411
Homepage URL
tomsaito-gi@umin.ac.j
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Departmental operating funds of the Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
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
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
1. 東京大学大学院医学系研究科・消化器内科
2. 富山大学学術研究部医学系内科学第三講座・消化器内科
3. 順天堂大学医学部附属順天堂医院・消化器内科
4. 岐阜大学医学部附属病院・第一内科
5. 神戸大学・消化器内科
6. 近畿大学病院・消化器内科
7. 兵庫医科大学・肝胆膵内科
8. 岐阜県総合医療センター・消化器内科
9. 岐阜市民病院・消化器内科
10. 埼玉医科大学総合医療センター・消化器・肝臓内科
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2028 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multicenter prospective registry-based observational study conducted by the WONDERFUL study group for thoracoabdominal complications associated with acute pancreatitis and surgical procedures. Machine-learning and deep-learning analyses using clinical and imaging data are also planned.
Management information
Registered date
| 2026 | Year | 07 | Month | 18 | Day |
Last modified on
| 2026 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071266
