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Fluid Collections Management in Severe Acute Pancreatitis (FCMSAP)

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ClinicalTrials.gov Identifier: NCT01321060
Recruitment Status : Unknown
Verified January 2011 by Weiqin Li, Nanjing University School of Medicine.
Recruitment status was:  Recruiting
First Posted : March 23, 2011
Last Update Posted : June 19, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Acute Pancreatitis Acute Pancreatic Fluid Collection Procedure: Aspiration Procedure: Catheter drainage Drug: Conservative treatment

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Management of Sterile Fluid Collections in Patients With Severe Acute Pancreatitis:a Randomized Controlled Trial
Study Start Date : January 2011
Estimated Primary Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Conservative treatment
Conservative treatment group with only drugs.
Drug: Conservative treatment
Including antibiotics,somatostatin, proton pump inhibitors and sufficient fluid resuscitation
Experimental: Continuous catheter drainage
Once the diameter of the fluid collection is more than 6cm, continuous catheter drainage will be applied.
Procedure: Catheter drainage
Experimental: Repeated aspiration
Once the diameter of the fluid collection is more than 6cm, aspiration is applied and draw the tube out immediately after aspiration.
Procedure: Aspiration


Outcome Measures

Primary Outcome Measures :
  1. pancreatic infection [ Time Frame: 28 days ]
  2. mortality [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. inflammation parameters [ Time Frame: 28 days ]
  2. intra abdominal pressure [ Time Frame: 28 days ]
  3. complications [ Time Frame: 28 days ]
    intestinal fistula , major bleeding, etc.

  4. ICU duration [ Time Frame: day one until discharge ]
  5. hospital duration [ Time Frame: day one until discharge ]
  6. SIRS [ Time Frame: 28 days ]
  7. MODS [ Time Frame: 28 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01321060


Contacts
Contact: Weiqin Li, Dr +86-025-80860066 kkb9832@gmail.com
Contact: Zhihui Tong, Dr +86-025-80860066 njzyantol@hotmail.com

Locations
China, Jiangsu
Department of SICU, Research Institute of General Surgery Jinling Hospital, Recruiting
Nanjing, Jiangsu, China, 210002
Contact: Weiqin Li, Dr    +86-025-80860066    kkb9832@gmail.com   
Principal Investigator: Weiqin Li, Dr         
Sponsors and Collaborators
Nanjing University School of Medicine
Jinling Hospital, China
More Information

Responsible Party: Weiqin Li, Director of surgical ICU, Nanjing University School of Medicine
ClinicalTrials.gov Identifier: NCT01321060     History of Changes
Other Study ID Numbers: RIGS
First Posted: March 23, 2011    Key Record Dates
Last Update Posted: June 19, 2012
Last Verified: January 2011

Keywords provided by Weiqin Li, Nanjing University School of Medicine:
severe acute pancreatitis
acute fluid collection
catheter drainage
repeated aspiration

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases