Walled off necrosis Necrotizing pancreatitis, acute pancreatitis
Conditions
Interventions
Encapsulation-oriented group
Patients will undergo EUS-guided drainage when necrotizing pancreatitis shows greater than or equal to 80 percent encapsulation on imaging, preferably contrast-enhanced CT
Sponsors
Saito Tomotaka
Nakai Yousuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosed with necrotizing pancreatitis based on contrast-enhanced CT (or plain CT/MRI if contrast is not feasible), according to the revised Atlanta classification Within 28 days from the onset of acute pancreatitis Age >=18 years at the time of consent; no restriction on sex Provided written informed consent by the subject or legally authorized representative after sufficient explanation of the study Currently hospitalized or receiving outpatient care at a participating study center
Exclusion criteria
Exclusion criteria: Unknown onset date of acute pancreatitis Already received transmural drainage stent placement for necrotizing pancreatitis Diagnosed with chronic pancreatitis Deemed ineligible for safe endoscopic treatment by the investigator Pregnant at the time of enrollment Judged by the principal or sub-investigator to be inappropriate for inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Success rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events during the follow-up period All-cause mortality during the follow-up period Days from randomization to clinical success Technical success rate of initial EUS-guided drainage Incidence of biliary and gastrointestinal strictures during the follow-up period Total number and duration of interventions related to necrotizing pancreatitis treatment Duration of placement of endoscopic and percutaneous drainage stents Success rate and total duration of surgical procedures related to necrotizing pancreatitis treatment Total hospital stay and ICU stay related to necrotizing pancreatitis treatment Total number of days of antibiotic administration during treatment and follow-up Costs related to interventions and hospitalization for necrotizing pancreatitis treatment Recurrence rate of pancreatic fluid collection (PFC) during the follow-up period Days to PFC recurrence Duration of treatment for recurrent PFC Incidence of new-onset diabetes, exocrine pancreatic insufficiency (e.g., steatorrhea, constipation, diarrhea, indigestion, bloating, tenesmus), and pancreatic cancer Use of pancreatic enzyme replacement therapy and initiation date Incidence and onset date of sarcopenia Changes in pancreatic morphology (measured by pancreatic volume) | — |
Contacts
Public ContactShuichi Tange
The University of Tokyo
Outcome results
None listed