Sever Acute Pancreatitis
Conditions
Interventions
Early on-demand PCD group:In addition to the standard treatment, ultrasound or computed tomography(CT) guided PCD will be performed within 24 hours of randomization. Early on demand endoscopic drainag
Standard-care group: standard treatment
Sponsors
Jinling Hospital affiliated to Nanjing University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years; 2. Able to provide informed consent; 3. Confirmed diagnosis of AP; 4. CT diagnosis of acute necrotic collection (ANC); 5. Technically able to be drained percutaneously, by ultrasound or CT guidance. 6. Confirmed persistent organ failure (either respiratory, renal and/or cardiovascular lasting for more than 48 hours) that had not resolved by Day 7; 7. During Day 8-Day 21, one or more of these criteria: (a) New-onset organ failure not present on Day 7 (no alleviation within 24 hours); (b) Organ failure (either single or multiple, modified Marshall score or SOFA score >= 2) persist for seven natural days from Day 1; (c) Aggravation of organ failure from that on Day 7 evidenced by increased modified Marshall score or SOFA score (no alleviation within 24 hours).
Exclusion criteria
Exclusion criteria: 1. Pregnant pancreatitis; 2. Chronic pancreatitis; 3. Pancreatic tumor-related pancreatitis; 4. Percutaneous or transluminal drainage or surgery is undertaken before admission; 5. Patients had a history of cardio-pulmonary resuscitation during this episode; 6. Patients with a known history of severe cardiovascular, respiratory, renal or hepatic disease defined as (1) greater than New York Heart Association class II heart failure, (2) active myocardial ischemia or (3) cardiovascular intervention within previous 60 days, (4) history of cirrhosis or (5) chronic kidney disease with creatinine clearance< 40 mL/min, or (6) chronic obstructive pulmonary disease with requirement for home oxygen.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Death and/or major complications during the index admission; | — |
Secondary
| Measure | Time frame |
|---|---|
| New-onset organ failure;Bleeding requiring intervention;Gastrointestinal perforation or fistula requiring intervention;Deteriorated organ failure;Organ failure score assessed at 14 and 21 days after randomization;Organ failure-free days during the 21-day period following randomization,;Intra-abdominal pressure for seven consecutive days after randomization and 14, 21 days after randomization;Incidence of infected pancreatic necrosis;Incidence of sepsis;New prescription of mechanical ventilation, renal replacement therapy and vasoactive agents;;Incidence of pancreatic fistula;Incidence of symptomatic SVT,;Requirement of minimally invasive debridement,;Requirement of open surgery,;Duration of ICU admission;Duration of hospital admission;Total cost;vital status of 90 days after randomzation; | — |
Countries
China
Contacts
Public ContactZhihui Tong
Jinling Hospital affiliated to Nanjing University
Outcome results
None listed