Local complications of acute pancreatitis and postoperative pancreatic fistula: what happens in real life
Official title: WONDERFUL Registry: A Multicenter Prospective Observational Study of Local Complications of Acute Pancreatitis and Postoperative Pancreatic Fistula
Run by Tokyo University · NCT07862088 · Data updated 2026-11-12
This multicenter registry tests how local pancreatic complications are managed in routine care and what outcomes look like over 180 days for adults.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 5000 (estimated) |
| Sponsor | Tokyo University Academic / other |
| Locations | 12 sites (Ōtsu, Shiga and 11 other locations) |
| Status | Recruiting |
| Started | September 14, 2023 |
| Main results expected | July 31, 2028 |
| Study ends | July 31, 2028 |
| Registry record updated | October 7, 2026 |
| Trial ID | NCT07862088 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older with a local complication of acute pancreatitis or postoperative pancreatic fistula requiring routine clinical management at participating centers.
✕Probably not a fit
Patients not experiencing local digestive complications or not receiving routine management at a participating site may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter prospective observational registry collecting data from routine clinical care. It documents patient characteristics, imaging, treatments, adverse events, recurrence, and outcomes for adults with local complications of acute pancreatitis or postoperative pancreatic fistula. Treatment decisions are made by treating physicians, not by the study protocol. The primary goal is to describe clinical success within 180 days, with secondary aims including technical success, adverse events, additional interventions, mortality, and healthcare use. Exploratory analyses will explore factors associated with outcomes without assigning any diagnostic or therapeutic interventions.
Why it matters
Potential benefit: If successful, the registry could clarify which management approaches are common and what outcomes look like across institutions.
How similar studies have gone: Prior work with similar observational registries in pancreatology suggest feasibility and can reveal real-world patterns, though direct benefit is not guaranteed by the registry.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Considered unsuitable for participation by the treating investigator. * Declines participation through the opt-out process.
Where it's running
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Department of Gastroenterology, Shiga University of Medical Science
Ōtsu, Shiga, Japan Recruiting -
Department of Gastroenterology, Graduate School of Medicine, Juntendo University
Bunkyō-Ku, Tokyo, Japan Recruiting -
The University of Tokyo Hospital
Tokyo, Tokyo, Japan Recruiting -
Department of Gastroenterology, Tokyo Women's Medical University
Tokyo, Tokyo, Japan Recruiting -
Department of Gastroenterology, Gifu Municipal Hospital
Gifu, Japan Recruiting -
Department of Gastroenterology, Gifu Prefectural General Medical Center
Gifu, Japan Recruiting
Show 6 more locations
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First Department of Internal Medicine, Gifu University Hospital
Gifu, Japan Recruiting -
Division of Hepatobiliary and Pancreatic Diseases, Department of Gastroenterology, Hyogo Medical University
Hyōgo, Japan Recruiting -
Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University
Kawagoe, Japan Recruiting -
Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine
Kobe, Japan Recruiting -
Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine
Ōsaka-sayama, Japan Recruiting -
Third Department of Internal Medicine, University of Toyama
Toyama, Japan Recruiting
Study contacts
- Principal investigator: Tomotaka Saito, MD, PhD — Graduate School of Medicine, The University of Tokyo
- Study coordinator: Yousuke Nakai, MD, PhD
- Email: ynakai-tky@umin.ac.jp
- Phone: +81-3-3353-8111
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Tissue-glue injection into the pancreas during pancreaticoduodenectomy
This trial will test whether injecting a tissue glue called N-butyl-2-cyanoacrylate into the pancreatic remnant during pancreaticoduodenectomy reduces postoperative pancreatic fistulas in patients with a soft pancreas and a small main duct.
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This trial will test whether a fecal microbiota transplant (FMT) can reduce late complications in adults with moderate to severe acute pancreatitis.
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This procedure will try injecting a tissue glue (Histoacryl) into the pancreas during pancreaticoduodenectomy to see if it reduces pancreatic leaks in people with a soft pancreas and a small pancreatic duct.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.