Acute Pancreatitis and Acute Fluid Collections

February 3, 2009 updated by: University Medical Center, Tuzla

Randomized Controlled Trial on Sterile Fluid Collections Management in Acute Pancreatitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: drainage
Procedure: Catheter drainage
Active Comparator: 2
Conservative treatment
Drug: Conservative treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Conversion to more aggressive procedure
Time Frame: Sep 2007
Sep 2007

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients turning culture positive, length of hospital stay, catheter dwell time, catheter problems and changes per patient
Time Frame: Oct 2007
Oct 2007

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center, Tuzla

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

November 5, 2008

First Submitted That Met QC Criteria

November 5, 2008

First Posted (Estimate)

November 6, 2008

Study Record Updates

Last Update Posted (Estimate)

February 4, 2009

Last Update Submitted That Met QC Criteria

February 3, 2009

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MB-68/02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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