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Acute Pancreatitis and Acute Fluid Collections

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00786929
First Posted: November 6, 2008
Last Update Posted: February 4, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Medical Center, Tuzla
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: November 5, 2008
First Posted: November 6, 2008
Last Update Posted: February 4, 2009
Last Verified: November 2008

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