UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058676 |
|---|---|
| Receipt number | R000067083 |
| Scientific Title | A multicenter randomized controlled trial investigating the timing of EUS-guided drainage for necrotizing pancreatitis after acute pancreatitis (WONDER-03 study) |
| Date of disclosure of the study information | 2025/08/11 |
| Last modified on | 2025/08/04 16:17:58 |
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Basic information
Public title
A multicenter randomized controlled trial comparing EUS-guided drainage strategies for necrotizing pancreatitis after acute pancreatitis (WONDER-03 study)
Acronym
WONDER-03 study
Scientific Title
A multicenter randomized controlled trial investigating the timing of EUS-guided drainage for necrotizing pancreatitis after acute pancreatitis (WONDER-03 study)
Scientific Title:Acronym
WONDER-03 study
Region
| Japan |
Condition
Condition
Necrotizing pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare outcomes of EUS-guided drainage performed after encapsulation versus before encapsulation in patients with necrotizing pancreatitis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical success rate within 180 days after randomization
Key secondary outcomes
1. Incidence of adverse events during the follow-up period
2. All-cause mortality during the follow-up period
3. Days from randomization to clinical success
4. Technical success rate of initial EUS-guided drainage
5. Incidence of biliary and gastrointestinal strictures during the follow-up period
6. Total number and duration of interventions related to necrotizing pancreatitis treatment
7. Duration of placement of endoscopic and percutaneous drainage stents
8. Success rate and total duration of surgical procedures related to necrotizing pancreatitis treatment
9. Total hospital stay and ICU stay related to necrotizing pancreatitis treatment
10. Total number of days of antibiotic administration during treatment and follow-up
11. Costs related to interventions and hospitalization for necrotizing pancreatitis treatment
12. Recurrence rate of pancreatic fluid collection (PFC) during the follow-up period
13. Days to PFC recurrence
14. Duration of treatment for recurrent PFC
15. Incidence of new-onset diabetes, exocrine pancreatic insufficiency (e.g., steatorrhea, constipation, diarrhea, indigestion, bloating, tenesmus), and pancreatic cancer
16. Use of pancreatic enzyme replacement therapy and initiation date
17. Incidence and onset date of sarcopenia
18. Changes in pancreatic morphology (measured by pancreatic volume)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Imaging preferably contrast-enhanced CT is performed every 7-10 days to assess the degree of encapsulation EUS-guided drainage is performed when >=80 percent encapsulation is confirmed and the patient is symptomatic The procedure is conducted within 72 hours after the latest imaging A single LAMS is placed and a nasocystic drain is generally added If no improvement is observed step-up interventions such as endoscopic necrosectomy or additional drainage are performed within 24-96 hours Consultation with the expert panel is conducted as needed.
Interventions/Control_2
EUS-guided drainage is performed at 4-5 weeks preferably 4 weeks after the onset of acute pancreatitis if the patient is symptomatic Imaging preferably contrast-enhanced CT is conducted and drainage is performed within 72 hours of the latest imaging A single LAMS is placed and a nasocystic drain is generally added If there is no improvement step-up interventions are performed within 24-96 hours If conservative therapy fails due to severe inflammation earlier intervention before 4 weeks is permitted with expert panel consultation as necessary.
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. Diagnosed with necrotizing pancreatitis based on contrast-enhanced CT (or plain CT/MRI if contrast is not feasible), according to the revised Atlanta classification
2. Within 28 days from the onset of acute pancreatitis
3. Age >=18 years at the time of consent; no restriction on sex
4. Provided written informed consent by the subject or legally authorized representative after sufficient explanation of the study
5. Currently hospitalized or receiving outpatient care at a participating study center
Key exclusion criteria
1. Unknown onset date** of acute pancreatitis
2. Already received transmural drainage stent placement for necrotizing pancreatitis
3. Diagnosed with chronic pancreatitis
4. Deemed ineligible for safe endoscopic treatment by the investigator
5. Pregnant at the time of enrollment
6. Judged by the principal or sub-investigator to be inappropriate for inclusion
Target sample size
214
Research contact person
Name of lead principal investigator
| 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 113-8655
TEL
03-3815-5411
tomsaito-gi@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 113-8655
TEL
0338155411
Homepage URL
tomsaito-gi@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
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
Research Ethics Committee, Graduate School ofMedicine and Faculty ofMedicine, The University ofTokyo
Address
7-3-1, Hongo Bunkyo-ku, Tokyo, Japan, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2025002P
Org. issuing International ID_1
Research Ethics Committee, Graduate School ofMedicine and Faculty of Medicine, The University ofTokyo
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（富山県）, 順天堂大学医学部附属順天堂医院（東京都）, 東京女子医科大学（東京都）, 兵庫医科大学（兵庫県）, 近畿大学（大阪府）, 滋賀医科大学（滋賀県）, 神戸大学（兵庫県）, 岐阜大学医学部附属病院（岐阜県）, 岐阜市民病院（岐阜県）, 岐阜県総合医療センター（岐阜県）, 埼玉医科大学総合医療センター（埼玉県）, 松波総合病院（岐阜県）, 大阪医科薬科大学（大阪府）, 帝京大学医学部附属溝口病院（神奈川県）, 鹿児島大学（鹿児島県）, 愛知医科大学（愛知県）, 北海道大学病院（北海道）, 香川大学（香川県）, 千葉大学（千葉県）, 亀田総合病院（千葉県）, 日本大学医学部（東京都）, 三重大学病院（三重県）, 九州大学病院（福岡県）, 岡山大学病院（岡山県）, 和歌山県立医科大学附属病院（和歌山県）, 聖マリアンナ医科大学（神奈川県）, 名古屋市立大学大学院（愛知県）, 関西医科大学総合医療センター（大阪府）, 横浜市立大学附属市民総合医療センター（神奈川県）, 福岡大学（福岡県）, 久留米大学（福岡県）, 名古屋大学（愛知県）, JA尾道総合病院（広島県）, 広島大学（広島県）, 仙台市医療センター仙台オープン病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 11 | 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
| 2025 | Year | 07 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 11 | Day |
Last follow-up date
| 2034 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 02 | Day |
Last modified on
| 2025 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067083
