Acute Pancreatitis and Acute Fluid Collections | NCT00786929

Studies
Acute Pancreatitis and Acute Fluid Collections

NCT00786929

Sponsor

University Medical Center, Tuzla

Status

Completed

Last Update Posted

Feb 4, 2009Estimated

Enrollment

63Actual

Phase

Phase 4

Conditions

Pancreatitis

Interventions

Catheter drainage
Conservative treatment

Countries

Bosnia and Herzegovina

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2003

Primary Completion Date

Feb 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Nov 5, 2008

First Submission Date that Met QC Criteria

Nov 5, 2008

First Posted Date

Nov 6, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2009

Last Update Posted Date

Feb 4, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

63Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
drainage	Experimental		Procedure: Catheter drainage
2	Active Comparator	Conservative treatment	Drug: Conservative treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Catheter drainage	Procedure		drainage
Conservative treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Conversion to more aggressive procedure		Sep 2007

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Clinical Center		Tuzla	TK	75000	Bosnia and Herzegovina

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
8105746	Background	Bradley EL 3rd. A clinically based classification system for acute pancreatitis. Ann Chir. 1993;47(6):537-41. No abstract available.

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases