Acute pancreatitis Digestive System Acute pancreatitis
Conditions
Interventions
Current interventions as of 18/06/2020:
This randomized, controlled, multi-center study, aims to compare the effect of the early on-demand drainage of ANC and standard treatment (delay
Sponsors
Department of science and technology of Jiangsu province
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 18/06/2020: 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: 7.1. New-onset organ failure not present on Day 7 (no alleviation within 24 hours) 7.2. Organ failure (either single or multiple, modified Marshall score or SOFA score=2) persist for seven natural days from Day 1 7.3. Aggravation of organ failure from that on Day 7 evidenced by increased modified Marshall score or SOFA score (no alleviation within 24 hours) Previous inclusion criteria: Inclusion criteria for the screening period Screening period starts from day 8 and extends to the end of the third week (day 21) consisting of 14 days: 1. Symptoms and signs of acute pancreatitis based on abdominal pain suggestive of AP, serum amylase at least three times the upper limit of normal, and/or characteristic findings of AP on computed tomography 2. Necrotic collection with available routes for ultrasound or CT guided percutaneous no matter sterile or infected 3. Confirmed persistent organ failure (either respiratory, renal or cardiovascular lasting for more than 48 hours), the organ failure score at day7 will be set as the baseline for the screening period 4. Age between 18 to 70 years old Inclusion Criteria for randomization during screening period: 1. Patients in the screening period 2. Signs of deterioration from the baseline during the screening period including: 2.1. New-onset organ failure (no alleviation within 24 hours) 2.2. Unalleviated organ failure (either single or multiple, modified Marshall score=2) lasting for at least seven days including the duration before the screening period 2.3. Aggravation of organ failure from the baseline (either single or multiple) evidence by increased modified Marshall score (no alleviation within 24 hours)
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 18/06/2020: 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 Previous exclusion criteria: 1. Pregnant 2. Chronic pancreatitis, recurrent acute pancreatitis or pancreatic tumor-related pancreatitis 3. Percutaneous or transluminal drainage or surgery undertaken before admission 4. Previous history of cardio-pulmonary resuscitation 5. History of severe cardiovascular, respiratory, renal, hepatic, hematologic, or immunologic disease defined as: 5.1. Greater than New York Heart Association class II heart failure 5.2. Active myocardial ischemia 5.3. Cardiovascular intervention within the previous 60 days 5.4. History of cirrhosis 5.5 Chronic kidney disease with creatinine clearance< 40 mL/min 5.6 Chronic obstructive pulmonary disease with requirement for home oxygen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 18/06/2020: Death and/ or major complications during the index admission from randomization to hospital discharge or death. Major complications refer to new-onset organ failure (cardiovascular, renal and respiratory), bleeding requiring intervention and gastrointestinal perforation or fistula requiring intervention. Previous primary outcome measure: 1. All-cause mortality in hospital 2. Major complications during the observational period | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 18/06/2020: 1. New-onset organ failure before the time of hospital discharge or death 2. Bleeding requiring intervention before the time of hospital discharge or death 3. Gastrointestinal perforation or fistula requiring intervention before the time of hospital discharge or death 4. Deteriorated organ failure before the time of hospital discharge or death 5. Organ failure score assessed at 14 and 21 days after randomization 6. Organ failure-free days during the 21-day period following randomization 7. Intra-abdominal pressure for seven consecutive days after randomization and 14, 21 days after randomization 8. Incidence of infected pancreatic necrosis before the time of hospital discharge or death 9. Incidence of sepsis before the time of hospital discharge or death 10. New prescription of mechanical ventilation, renal replacement therapy and vasoactive agents before the time of hospital discharge or death 11. Incidence of pancreatic fistula before the time of hospital discharge or death 12. Incidence of symptomatic splenic vein thrombosis before the time of hospital discharge or death 13. Requirement of minimally inv supraventricular tachycardia asive debridement before the time of hospital discharge or death 14. Requirement of open surgery before the time of hospital discharge or death 15. Duration of ICU admission before the time of hospital discharge or death 16. Duration of hospital admission before the time of hospital discharge or death 17. Total cost before the time of hospital discharge or death 18. Vital status on 90 days after randomization Previous secondary outcome measures: 1. The fluctuation of o | — |
Countries
China
Contacts
Public ContactQu Cheng
Outcome results
None listed