Fluid Collections Management in Severe Acute Pancreatitis

Study Overview
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Brief Summary
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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.

Official Title
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Management of Sterile Fluid Collections in Patients With Severe Acute Pancreatitis:a Randomized Controlled Trial

Conditions
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Acute Pancreatitis, Acute Pancreatic Fluid Collection

Intervention / Treatment
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* Procedure: Aspiration
* Procedure: Catheter drainage
* Drug: Conservative treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conservative treatment<br>Conservative treatment group with only drugs. | Drug: Conservative treatment<br>* Including antibiotics,somatostatin, proton pump inhibitors and sufficient fluid resuscitation<br>|
| Experimental: Continuous catheter drainage<br>Once the diameter of the fluid collection is more than 6cm, continuous catheter drainage will be applied. | Procedure: Catheter drainage<br> <br> |
| Experimental: Repeated aspiration<br>Once the diameter of the fluid collection is more than 6cm, aspiration is applied and draw the tube out immediately after aspiration. | Procedure: Aspiration<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pancreatic infection |  | 28 days | 
| mortality |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inflammation parameters |  | 28 days | 
| intra abdominal pressure |  | 28 days | 
| complications | intestinal fistula , major bleeding, etc. | 28 days | 
| ICU duration |  | day one until discharge | 
| hospital duration |  | day one until discharge | 
| SIRS |  | 28 days | 
| MODS |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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severe acute pancreatitis, acute fluid collection, catheter drainage, repeated aspiration