Necrotizing pancreatitis
Conditions
Interventions
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 ad
Sponsors
The University of Tokyo
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical success rate within 180 days after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Japan
Contacts
Public ContactTomotaka Saito
Graduate School of Medicine, The University of Tokyo Department of Gastroenterology
Outcome results
None listed