ISRCTN16728921
Completed
未知
The timing and indications for drainage in acute pancreatitis patients with acute necrotic collections and persistent organ failure: a pilot randomized controlled trial comparing early on-demand drainage and standard management
Jinling Hospital affiliated to Nanjing University0 sites30 target enrollmentStarted: January 23, 2020Last updated:
Overview
- Phase
- 未知
- Status
- Completed
- Sponsor
- Jinling Hospital affiliated to Nanjing University
- Enrollment
- 30
Overview
Brief Summary
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33595879/ (added 20/01/2022)
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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)
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
Investigators
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