Fluid Collections Management in Severe Acute Pancreatitis

Not Applicable

• Conditions: Acute Pancreatitis; Acute Pancreatic Fluid Collection
• Interventions: Procedure: Catheter drainage; Drug: Conservative treatment; Procedure: Aspiration

• Registration Number: NCT01321060
• Lead Sponsor: Nanjing University School of Medicine

Brief Summary

Acute fluid collections is common in patients with severe acute pancreatitis (SAP). But the treatment for this is controversial. In this study, the investigators aim to evaluate the different effects of three different treatment protocols which is repeated aspiration, continuous catheter drainage and conservative treatment. The investigators suppose repeated aspiration could not only solve acute fluid collections, but also lower the rate of pancreatic infection.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-01
• Study Start: 2011-01
• Study First Submitted: 2011-03-22
• Study First Submitted QC: 2011-03-22
• Study First Posted: 2011-03-23
• Last Update Submitted: 2012-06-16
• Last Update Posted: 2012-06-19
• Primary Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

• Symptoms and signs of acute pancreatitis according to Atlanta criteria and if pancreatic or/and peripancreatic fluid collections were confirmed by ultrasound and computed tomography examination
• CT density < 30Hu
• Within 7 days from the onset of the disease
• Available approach for percutaneous penetrate

Exclusion Criteria

• Pregnant pancreatitis
• Receiving surgery or aspiration before;need of early surgery
• Infected fluid collection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous catheter drainage	Catheter drainage	Once the diameter of the fluid collection is more than 6cm, continuous catheter drainage will be applied.
Conservative treatment	Conservative treatment	Conservative treatment group with only drugs.
Repeated aspiration	Aspiration	Once the diameter of the fluid collection is more than 6cm, aspiration is applied and draw the tube out immediately after aspiration.

Primary Outcome Measures

Name	Time	Method
pancreatic infection	28 days
mortality	28 days

Secondary Outcome Measures

Name	Time	Method
inflammation parameters	28 days
intra abdominal pressure	28 days
complications	28 days	intestinal fistula , major bleeding, etc.
ICU duration	day one until discharge
hospital duration	day one until discharge
SIRS	28 days
MODS	28 days

Trial Locations

Locations (1)

Department of SICU, Research Institute of General Surgery Jinling Hospital,; 🇨🇳 Nanjing, Jiangsu, China