NCT00786929

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2003

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2008

Completed
Last Updated

February 4, 2009

Status Verified

November 1, 2008

Enrollment Period

3.9 years

First QC Date

November 5, 2008

Last Update Submit

February 3, 2009

Conditions

Pancreatitis

Keywords

Conversion to more aggressive treatment of recurrent fluid collection

Outcome Measures

Primary Outcomes (1)

  • Conversion to more aggressive procedure

    Sep 2007

Secondary Outcomes (1)

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

    Oct 2007

Study Arms (2)

drainage

EXPERIMENTAL
Procedure: Catheter drainage

2

ACTIVE COMPARATOR

Conservative treatment

Drug: Conservative treatment

Interventions

Catheter drainagePROCEDURE
drainage
Conservative treatmentDRUG
2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinical Center

Tuzla, TK, 75000, Bosnia and Herzegovina

Location

Related Publications (1)

  • Bradley EL 3rd. A clinically based classification system for acute pancreatitis. Ann Chir. 1993;47(6):537-41. No abstract available.

    PMID: 8105746BACKGROUND

Related Links

MeSH Terms

Conditions

Pancreatitis

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 5, 2008

First Posted

November 6, 2008

Study Start

March 1, 2003

Primary Completion

February 1, 2007

Study Completion

December 1, 2007

Last Updated

February 4, 2009

Record last verified: 2008-11

Locations

BO(1)