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Fluid Collections Management in Severe Acute Pancreatitis (FCMSAP)

Primary Purpose

Acute Pancreatitis, Acute Pancreatic Fluid Collection

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Aspiration
Catheter drainage
Conservative treatment
Sponsored by
Nanjing University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pancreatitis focused on measuring severe acute pancreatitis, acute fluid collection, catheter drainage, repeated aspiration

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of SICU, Research Institute of General Surgery Jinling Hospital,Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Conservative treatment

Continuous catheter drainage

Repeated aspiration

Arm Description

Conservative treatment group with only drugs.

Once the diameter of the fluid collection is more than 6cm, continuous catheter drainage will be applied.

Once the diameter of the fluid collection is more than 6cm, aspiration is applied and draw the tube out immediately after aspiration.

Outcomes

Primary Outcome Measures

pancreatic infection
mortality

Secondary Outcome Measures

inflammation parameters
intra abdominal pressure
complications
intestinal fistula , major bleeding, etc.
ICU duration
hospital duration
SIRS
MODS

Full Information

First Posted
March 22, 2011
Last Updated
June 16, 2012
Sponsor
Nanjing University School of Medicine
Collaborators
Jinling Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT01321060
Brief Title
Fluid Collections Management in Severe Acute Pancreatitis
Acronym
FCMSAP
Official Title
Management of Sterile Fluid Collections in Patients With Severe Acute Pancreatitis:a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing University School of Medicine
Collaborators
Jinling Hospital, China

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pancreatitis, Acute Pancreatic Fluid Collection
Keywords
severe acute pancreatitis, acute fluid collection, catheter drainage, repeated aspiration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
87 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conservative treatment
Arm Type
Active Comparator
Arm Description
Conservative treatment group with only drugs.
Arm Title
Continuous catheter drainage
Arm Type
Experimental
Arm Description
Once the diameter of the fluid collection is more than 6cm, continuous catheter drainage will be applied.
Arm Title
Repeated aspiration
Arm Type
Experimental
Arm Description
Once the diameter of the fluid collection is more than 6cm, aspiration is applied and draw the tube out immediately after aspiration.
Intervention Type
Procedure
Intervention Name(s)
Aspiration
Intervention Type
Procedure
Intervention Name(s)
Catheter drainage
Intervention Type
Drug
Intervention Name(s)
Conservative treatment
Intervention Description
Including antibiotics,somatostatin, proton pump inhibitors and sufficient fluid resuscitation
Primary Outcome Measure Information:
Title
pancreatic infection
Time Frame
28 days
Title
mortality
Time Frame
28 days
Secondary Outcome Measure Information:
Title
inflammation parameters
Time Frame
28 days
Title
intra abdominal pressure
Time Frame
28 days
Title
complications
Description
intestinal fistula , major bleeding, etc.
Time Frame
28 days
Title
ICU duration
Time Frame
day one until discharge
Title
hospital duration
Time Frame
day one until discharge
Title
SIRS
Time Frame
28 days
Title
MODS
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weiqin Li, Dr
Phone
+86-025-80860066
Email
kkb9832@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhihui Tong, Dr
Phone
+86-025-80860066
Email
njzyantol@hotmail.com
Facility Information:
Facility Name
Department of SICU, Research Institute of General Surgery Jinling Hospital,
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weiqin Li, Dr
Phone
+86-025-80860066
Email
kkb9832@gmail.com
First Name & Middle Initial & Last Name & Degree
Weiqin Li, Dr

12. IPD Sharing Statement

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Fluid Collections Management in Severe Acute Pancreatitis

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