Early on-demand drainage versus standard management in acute necrotizing pancreatitis with early persistent organ failure

Not Applicable

Completed

• Conditions: Acute pancreatitis; Digestive System

• Registration Number: ISRCTN16728921
• Lead Sponsor: Jinling Hospital affiliated to Nanjing University

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33595879/ (added 20/01/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-23
• Study Completion: 2020-12-31
• Last Update Posted: 1 February 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Current participant inclusion criteria as of 16/06/2020:
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. Admitted within 7 days from onset of abdominal pain
3. Confirmed persistent organ failure (respiratory, circulatory, renal) failure (revised Marshall score = 2 points for at least 48 h) and still unresolved 7 days after onset
4. Age between 18 to 70 years old
5. Acute necrotic collection with available routes for ultrasound or CT guided percutaneous drainage

Previous participant inclusion criteria:
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. The duration of disease up to 1 week (starting with abdominal pain)
3. Confirmed persistent organ failure (respiratory, circulatory, renal) failure (revised Marshall score = 2 points and the duration of up to 48 hours)
4. Age between 18 to 70 years old
5. Necrotic collection with available routes for ultrasound or CT guided percutaneous no matter sterile or infected

Exclusion Criteria

Current participant exclusion criteria as of 16/06/2020:
1. Pregnancy
2. Chronic pancreatitis or pancreatic tumor-related pancreatitis
3. Percutaneous or transluminal drainage or surgery undertaken before admission
4. Previous history of cardio-pulmonary resuscitation during the present admission for AP
5. Expected to die within 48 h
6. Emergency surgery required due to active bleeding, bowel ischemia or necrosis, etc.
7. History of severe co-morbidities:
7.1. Greater than New York Heart Association class II heart failure
7.2. Active myocardial ischemia
7.3. History of cirrhosis
7.4 Chronic kidney disease with creatinine clearance <40 mL/min
7.5 Chronic obstructive pulmonary disease requiring home oxygen

Previous participant 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified