Fluid Collections Management in Severe Acute Pancreatitis | NCT01321060

Studies
Fluid Collections Management in Severe Acute Pancreatitis

NCT01321060

Sponsor

Nanjing University School of Medicine

Status

Unknown status

Last Update Posted

Jun 19, 2012Estimated

Enrollment

87Estimated

Phase

Not Applicable

Conditions

Acute Pancreatitis
Acute Pancreatic Fluid Collection

Interventions

Aspiration
Catheter drainage
Conservative treatment

Countries

China

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

Jan 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Dec 2012Estimated

Completion Date

Not provided

First Submitted Date

Mar 22, 2011

First Submission Date that Met QC Criteria

Mar 22, 2011

First Posted Date

Mar 23, 2011Estimated

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

Jun 16, 2012

Last Update Posted Date

Jun 19, 2012Estimated

Name	Class
Jinling Hospital, China	OTHER

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

Acute fluid collections is common in patients with severe acute pancreatitis (SAP). But the treatment for this is controversial. In this study, the investigators aim to evaluate the different effects of three different treatment protocols which is repeated aspiration, continuous catheter drainage and conservative treatment. The investigators suppose repeated aspiration could not only solve acute fluid collections, but also lower the rate of pancreatic infection.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

87Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Conservative treatment	Active Comparator	Conservative treatment group with only drugs.	Drug: Conservative treatment
Continuous catheter drainage	Experimental	Once the diameter of the fluid collection is more than 6cm, continuous catheter drainage will be applied.	Procedure: Catheter drainage
Repeated aspiration	Experimental	Once the diameter of the fluid collection is more than 6cm, aspiration is applied and draw the tube out immediately after aspiration.	Procedure: Aspiration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aspiration	Procedure		Repeated aspiration
Catheter drainage

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pancreatic infection		28 days
mortality		28 days

Secondary Outcomes

Measure	Description	Time Frame
inflammation parameters		28 days
intra abdominal pressure		28 days
complications

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Symptoms and signs of acute pancreatitis according to Atlanta criteria and if pancreatic or/and peripancreatic fluid collections were confirmed by ultrasound and computed tomography examination
CT density < 30Hu
Within 7 days from the onset of the disease
Available approach for percutaneous penetrate

Exclusion Criteria:

Pregnant pancreatitis
Receiving surgery or aspiration before;need of early surgery
Infected fluid collection

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Weiqin Li, Dr	Contact	+86-025-80860066		kkb9832@gmail.com
Zhihui Tong, Dr	Contact	+86-025-80860066		njzyantol@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of SICU, Research Institute of General Surgery Jinling Hospital,	Recruiting	Nanjing	Jiangsu	210002	China

Condition Browse Module

MeSH Terms

ID	Term
D010195	Pancreatitis

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided