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Clinical Trials/ISRCTN16728921
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

Sponsor
Jinling Hospital affiliated to Nanjing University

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