Acute Pancreatitis and Acute Fluid Collections

This study has been completed.
Sponsor:
Information provided by:
University Medical Center, Tuzla
ClinicalTrials.gov Identifier:
NCT00786929
First received: November 5, 2008
Last updated: February 3, 2009
Last verified: November 2008
  Purpose

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.


Condition Intervention Phase
Pancreatitis
Procedure: Catheter drainage
Drug: Conservative treatment
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial on Sterile Fluid Collections Management in Acute Pancreatitis

Resource links provided by NLM:


Further study details as provided by University Medical Center, Tuzla:

Primary Outcome Measures:
  • Conversion to more aggressive procedure [ Time Frame: Sep 2007 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of patients turning culture positive, length of hospital stay, catheter dwell time, catheter problems and changes per patient [ Time Frame: Oct 2007 ] [ Designated as safety issue: Yes ]

Enrollment: 63
Study Start Date: March 2003
Study Completion Date: December 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: drainage Procedure: Catheter drainage
Active Comparator: 2
Conservative treatment
Drug: Conservative treatment

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00786929

Locations
Bosnia and Herzegovina
University Clinical Center
Tuzla, TK, Bosnia and Herzegovina, 75000
Sponsors and Collaborators
University Medical Center, Tuzla
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00786929     History of Changes
Other Study ID Numbers: MB-68/02
Study First Received: November 5, 2008
Last Updated: February 3, 2009
Health Authority: Bosnia and Herzegovina: Federal Ministry of Health

Keywords provided by University Medical Center, Tuzla:
Conversion to more aggressive treatment of recurrent fluid collection

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 23, 2014