Acute PancreatitisWONDERFULNCT07862088
Management and Outcomes of Local Complications of Acute Pancreatitis and Postoperative Pancreatic Fistula
An observational study of Acute Pancreatitis and Pancreatic Fluid Collection, run by Tokyo University at 12 sites in Japan.
Trial summary
This multicenter prospective observational registry will evaluate the clinical characteristics and treatment outcomes of adults with local complications of acute pancreatitis or postoperative pancreatic fistula. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis, Pancreatic Fluid Collection, Postoperative Pancreatic Fistula
- What is being tested?
- Routine Clinical Management of Local Complications
- Type of treatment
- Surgery or procedure
- How many people
- 5,000 participants
- Where
- 12 sitesJapan
- Study dates
- 14 Sep 2023to 31 Jul 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults receiving routine inpatient or outpatient care at participating institutions for local complications of acute pancreatitis or postoperative pancreatic fistula.
Who may be able to join
- Age 18 years or older.
- Diagnosed with a local complication of acute pancreatitis, including acute exacerbation of chronic pancreatitis, or postoperative pancreatic fistula requiring routine clinical management.
- Receiving inpatient or outpatient care at a participating institution.
Who cannot join
- Considered unsuitable for participation by the treating investigator.
- Declines participation through the opt-out process.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
Japan12 sites, 12 recruiting
- Recruiting
Department of Gastroenterology, Graduate School of Medicine, Juntendo University
Bunkyō-Ku, Tokyo
Hiroyuki Isayama
Toshio Fujisawa
- Recruiting
Department of Gastroenterology, Gifu Municipal Hospital
Gifu
Keisuke Iwata
- Recruiting
Department of Gastroenterology, Gifu Prefectural General Medical Center
Gifu
Hironao Ichikawa, ichi.hiro.m.0814@gmail.com
Naoki Mita, mitanao8@yahoo.co.jp
- Recruiting
First Department of Internal Medicine, Gifu University Hospital
Gifu
Shinya Uemura
Akinori Maruta
- Recruiting
Division of Hepatobiliary and Pancreatic Diseases, Department of Gastroenterology, Hyogo Medical University
Hyōgo
Hideyuki Shiomi
- Recruiting
Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University
Kawagoe
Saburo Matsubara
Keito Nakagawa
- Recruiting
Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine
Kobe
Mitsuhiro Masuda
Atsuhiro Masuda
- Recruiting
Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine
Ōsaka-sayama
Mamoru Takenaka
Shunsuke Omoto
- Recruiting
Department of Gastroenterology, Shiga University of Medical Science
Ōtsu, Shiga, 520-2192
Shuhei Shintani, +81-77-548-2111, s.shuhei513@gmail.com
- Recruiting
The University of Tokyo Hospital
Tokyo, Tokyo, 113-8655
Tomotaka Saito, MD, PhD, +81-3-3815-5411 ext. 37199, tomsaito-gi@umin.ac.jp
- Recruiting
Department of Gastroenterology, Tokyo Women's Medical University
Tokyo, Tokyo, 162-8666
Ryunosuke Hakuta, +81-3-3353-8111, ryuhakuta@gmail.com
- Recruiting
Third Department of Internal Medicine, University of Toyama
Toyama
Ichiro Yasuda
Nobuhiko Hayashi
About this study
Official title: WONDERFUL Registry: A Multicenter Prospective Observational Study of Local Complications of Acute Pancreatitis and Postoperative Pancreatic Fistula
This multicenter prospective observational registry will evaluate the clinical characteristics and treatment outcomes of adults with local complications of acute pancreatitis or postoperative pancreatic fistula. Data generated during routine clinical care, including patient characteristics, imaging findings, treatments, adverse events, recurrence, and clinical outcomes, will be collected. Treatment is determined by the treating physicians and is not assigned by the study protocol.
Read the detailed description
Local complications of acute pancreatitis, including pancreatic and peripancreatic fluid collections, may require conservative management, endoscopic or percutaneous drainage, necrosectomy, or surgery. Similar fluid collections may occur after pancreatic surgery as a result of postoperative pancreatic fistula. Evidence regarding treatment selection, timing, and outcomes remains limited because individual centers encounter relatively few cases.
This prospective multicenter registry will collect clinical, laboratory, imaging, treatment, and outcome data generated during routine care. The primary objective is to evaluate clinical success within 180 days after enrollment. Secondary objectives include technical success, adverse events, additional interventions, recurrence, mortality, and healthcare utilization.
Exploratory analyses will evaluate patient, disease, imaging, and treatment factors associated with clinical outcomes. No diagnostic or therapeutic intervention is assigned by the study protocol.
- Being tested
- Routine Clinical Management of Local Complications
- Keywords
- acute peripancreatic fluid collection, acute necrotic collection, walled-off necrosis, pancreatic pseudocyst, endoscopic drainage, percutaneous drainage, necrosectomy, postoperative pancreatic fistula
- Medical subject headings
- Pancreatitis, Pancreatic Pseudocyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Clinical Management of Local ComplicationsProcedure or surgery
Participants receive routine clinical management selected by their treating clinicians. Management may include conservative treatment, endoscopic or percutaneous drainage, necrosectomy, stent placement, or surgery when clinically indicated. No diagnostic or therapeutic procedure is assigned by the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Patients With Local Complications of Acute Pancreatitis or Postoperative Pancreatic Fistula | Adults receiving routine clinical care for local complications of acute pancreatitis or postoperative pancreatic fistula. Management may include conservative care, endoscopic or percutaneous intervention, or surgery. No intervention is assigned by the study. Receives: Procedure: Routine Clinical Management of Local Complications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Achieving Clinical Success Within 180 Days
Clinical success is defined as resolution of the symptoms and clinical signs that required treatment, together with resolution or marked reduction of the target fluid collection on follow-up imaging. For infection-related cases, improvement in at least two of body temperature, white blood cell count, and C-reactive protein is required.
Measured: Within 180 days after enrollment
Secondary outcomes (7)
Proportion of Participants With Technical Success of the Initial Intervention
Technical success is defined as successful completion of the intended endoscopic, percutaneous, or surgical procedure. This measure will be assessed only among participants who undergo an intervention.
Measured: On the day of the initial intervention (1 day per participant)
Procedure-Related Adverse Events
Proportion of participants experiencing an adverse event considered related to an endoscopic, percutaneous, or surgical procedure.
Measured: Within 180 days after enrollment
Need for Additional Intervention
Proportion of participants requiring an additional endoscopic, percutaneous, or surgical intervention for the index local complication.
Measured: Within 180 days after enrollment
Recurrence of the Target Fluid Collection
Proportion of participants with recurrence of a symptomatic target fluid collection requiring treatment after initial clinical success.
Measured: Within 180 days after enrollment
All-Cause Mortality
Proportion of participants who die from any cause.
Measured: Within 180 days after enrollment
Number of Interventions
Total number of endoscopic, percutaneous, and surgical interventions performed for the index local complication.
Measured: Within 180 days after enrollment
Total Duration of Hospitalization
Total number of inpatient days related to management of the index local complication.
Measured: Within 180 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start14 Sep 2023
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Tokyo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yousuke Nakai, Tokyo Women's Medical University
- Investigators
- Tomotaka Saito, MD, PhD, Principal investigator, Graduate School of Medicine, The University of Tokyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07862088
- Sponsor's protocol ID
- 2023131NI
- Other IDs
- UMIN000062276
- Acronym
- WONDERFUL
- Status last verified
- Oct 2026
- First submitted
- 16 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.
PubMed 23100216
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WONDERFUL Registry: A Multicenter Prospective Observational Study of Local Complications of Acute Pancreatitis and Postoperative Pancreatic Fistula
- ClinicalTrials.gov ID
- NCT07862088
- Acronym / sponsor ID
- WONDERFUL / 2023131NI
- Keywords
- acute peripancreatic fluid collection, acute necrotic collection, walled-off necrosis, pancreatic pseudocyst, endoscopic drainage, percutaneous drainage, necrosectomy, postoperative pancreatic fistula
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Tokyo UniversityUniversity, hospital or other
- Study start
- 14 Sep 2023 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicenter prospective observational registry will evaluate the clinical characteristics and treatment outcomes of adults with local complications of acute pancreatitis or postoperative pancreatic fistula. Data generated during routine clinical care, including patient characteristics, imaging findings, treatments, adverse events, recurrence, and clinical outcomes, will be collected. Treatment is determined by the treating physicians and is not assigned by the study protocol.
Detailed description
Local complications of acute pancreatitis, including pancreatic and peripancreatic fluid collections, may require conservative management, endoscopic or percutaneous drainage, necrosectomy, or surgery. Similar fluid collections may occur after pancreatic surgery as a result of postoperative pancreatic fistula. Evidence regarding treatment selection, timing, and outcomes remains limited because individual centers encounter relatively few cases.
This prospective multicenter registry will collect clinical, laboratory, imaging, treatment, and outcome data generated during routine care. The primary objective is to evaluate clinical success within 180 days after enrollment. Secondary objectives include technical success, adverse events, additional interventions, recurrence, mortality, and healthcare utilization.
Exploratory analyses will evaluate patient, disease, imaging, and treatment factors associated with clinical outcomes. No diagnostic or therapeutic intervention is assigned by the study protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients With Local Complications of Acute Pancreatitis or Postoperative Pancreatic Fistula | – | Procedure: Routine Clinical Management of Local ComplicationsAdults receiving routine clinical care for local complications of acute pancreatitis or postoperative pancreatic fistula. Management may include conservative care, endoscopic or percutaneous intervention, or surgery. No intervention is assigned by the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults receiving routine inpatient or outpatient care at participating institutions for local complications of acute pancreatitis or postoperative pancreatic fistula.
Key inclusion criteria (3 listed)
- Age 18 years or older.
- Diagnosed with a local complication of acute pancreatitis, including acute exacerbation of chronic pancreatitis, or postoperative pancreatic fistula requiring routine clinical management.
- Receiving inpatient or outpatient care at a participating institution.
Key exclusion criteria (2 listed)
- Considered unsuitable for participation by the treating investigator.
- Declines participation through the opt-out process.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine Clinical Management of Local ComplicationsParticipants receive routine clinical management selected by their treating clinicians. Management may include conservative treatment, endoscopic or percutaneous drainage, necrosectomy, stent placement, or surgery when clinically indicated. No diagnostic or therapeutic procedure is assigned by the study protocol. | Procedure or surgery | Patients With Local Complications of Acute Pancreatitis or Postoperative Pancreatic Fistula |
Primary outcome
Proportion of Participants Achieving Clinical Success Within 180 Days
Time frame: Within 180 days after enrollment
Clinical success is defined as resolution of the symptoms and clinical signs that required treatment, together with resolution or marked reduction of the target fluid collection on follow-up imaging. For infection-related cases, improvement in at least two of body temperature, white blood cell count, and C-reactive protein is required.
7 secondary outcomes
Proportion of Participants With Technical Success of the Initial Intervention
Time frame: On the day of the initial intervention (1 day per participant)
Procedure-Related Adverse Events
Time frame: Within 180 days after enrollment
Need for Additional Intervention
Time frame: Within 180 days after enrollment
Recurrence of the Target Fluid Collection
Time frame: Within 180 days after enrollment
All-Cause Mortality
Time frame: Within 180 days after enrollment
Number of Interventions
Time frame: Within 180 days after enrollment
Total Duration of Hospitalization
Time frame: Within 180 days after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Background: PubMed 23100216Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.
- UMIN Clinical Trials Registry record UMIN000062276Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tomotaka Saito, MD, PhD principal investigator
Graduate School of Medicine, The University of Tokyo
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pancreatitis and Pancreatic Fluid Collection, run by Tokyo University at 12 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yousuke Nakai, MD, PhD (+81-3-3353-8111, ynakai-tky@umin.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Achieving Clinical Success Within 180 Days (time frame: Within 180 days after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07862088, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.