Acute Pancreatitis and Acute Fluid Collections

Pancreatitis Clinical Trial

Official title:

Randomized Controlled Trial on Sterile Fluid Collections Management in Acute Pancreatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00786929
• Other study ID #: MB-68/02
• Status: Completed
• Phase: Phase 4
• First received: November 5, 2008
• Last updated: February 3, 2009
• Start date: March 2003
• Est. completion date: December 2007

Study information

• Verified date: November 2008
• Source: University Medical Center, Tuzla
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bosnia and Herzegovina: Federal Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate if percutaneous drainage of sterile fluid collections recurring after initial aspiration in acute pancreatitis yielded better results than their conservative management.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: December 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Symptoms and signs of acute pancreatitis and if pancreatic or/and peripancreatic fluid collections were confirmed by ultrasound and computed tomography examination

Exclusion Criteria:

• Collections resulting from pancreatic surgery, chronic pancreatitis and encapsulated collections and collections with uncertainty about the relationship between the collections and clinical symptoms and signs of acute pancreatitis were excluded.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatitis

Intervention

Procedure:
• Catheter drainage

Drug:
• Conservative treatment

Locations

Country	Name	City	State
Bosnia and Herzegovina	University Clinical Center	Tuzla	TK

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center, Tuzla

Country where clinical trial is conducted

Bosnia and Herzegovina, 

References & Publications (1)

Bradley EL 3rd. A clinically based classification system for acute pancreatitis. Ann Chir. 1993;47(6):537-41. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conversion to more aggressive procedure		Sep 2007	Yes
Secondary	Number of patients turning culture positive, length of hospital stay, catheter dwell time, catheter problems and changes per patient		Oct 2007	Yes

External Links

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