Fluid Collections Management in Severe Acute Pancreatitis (FCMSAP)

Nanjing University School of Medicine

Status: Unknown

Conditions: Acute Pancreatitis; Acute Pancreatic Fluid Collection

Treatments: Procedure: Catheter drainage; Drug: Conservative treatment; Procedure: Aspiration

Study type: Interventional

Funder types: Other

Identifiers

NCT01321060

RIGS

Details and patient eligibility

About

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.

Enrollment: 87 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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87 participants in 3 patient groups

Conservative treatment

Active Comparator group

Description:

Conservative treatment group with only drugs.

Treatment:

Drug: Conservative treatment

Continuous catheter drainage

Experimental group

Description:

Once the diameter of the fluid collection is more than 6cm, continuous catheter drainage will be applied.

Treatment:

Procedure: Catheter drainage

Repeated aspiration

Experimental group

Description:

Once the diameter of the fluid collection is more than 6cm, aspiration is applied and draw the tube out immediately after aspiration.

Treatment:

Procedure: Aspiration