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Acute Pancreatitis and Acute Fluid Collections

Primary Purpose

Pancreatitis

Status
Completed
Phase
Phase 4
Locations
Bosnia and Herzegovina
Study Type
Interventional
Intervention
Catheter drainage
Conservative treatment
Sponsored by
University Medical Center, Tuzla
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatitis focused on measuring Conversion to more aggressive treatment of recurrent fluid collection

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Clinical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

drainage

2

Arm Description

Conservative treatment

Outcomes

Primary Outcome Measures

Conversion to more aggressive procedure

Secondary Outcome Measures

Number of patients turning culture positive, length of hospital stay, catheter dwell time, catheter problems and changes per patient

Full Information

First Posted
November 5, 2008
Last Updated
February 3, 2009
Sponsor
University Medical Center, Tuzla
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1. Study Identification

Unique Protocol Identification Number
NCT00786929
Brief Title
Acute Pancreatitis and Acute Fluid Collections
Official Title
Randomized Controlled Trial on Sterile Fluid Collections Management in Acute Pancreatitis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Medical Center, Tuzla

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis
Keywords
Conversion to more aggressive treatment of recurrent fluid collection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
drainage
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Arm Description
Conservative treatment
Intervention Type
Procedure
Intervention Name(s)
Catheter drainage
Intervention Type
Drug
Intervention Name(s)
Conservative treatment
Primary Outcome Measure Information:
Title
Conversion to more aggressive procedure
Time Frame
Sep 2007
Secondary Outcome Measure Information:
Title
Number of patients turning culture positive, length of hospital stay, catheter dwell time, catheter problems and changes per patient
Time Frame
Oct 2007

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
University Clinical Center
City
Tuzla
State/Province
TK
ZIP/Postal Code
75000
Country
Bosnia and Herzegovina

12. IPD Sharing Statement

Citations:
PubMed Identifier
8105746
Citation
Bradley EL 3rd. A clinically based classification system for acute pancreatitis. Ann Chir. 1993;47(6):537-41. No abstract available.
Results Reference
background
Links:
URL
http://mc.manuscriptcentral.com/surgendosc
Description
Related Info
URL
http://pancreas.edmgr.com/
Description
Related Info
URL
http://ees.elsevier.com/jvir/
Description
Related Info

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Acute Pancreatitis and Acute Fluid Collections

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