Fluid Collections Management in Severe Acute Pancreatitis (FCMSAP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Nanjing University School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Jinling Hospital, China
Information provided by (Responsible Party):
Weiqin Li, Nanjing University School of Medicine
ClinicalTrials.gov Identifier:
NCT01321060
First received: March 22, 2011
Last updated: June 16, 2012
Last verified: January 2011
  Purpose

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 Intervention
Acute Pancreatitis
Acute Pancreatic Fluid Collection
Procedure: Aspiration
Procedure: Catheter drainage
Drug: Conservative treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Management of Sterile Fluid Collections in Patients With Severe Acute Pancreatitis:a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Nanjing University School of Medicine:

Primary Outcome Measures:
  • pancreatic infection [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • inflammation parameters [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • intra abdominal pressure [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • complications [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    intestinal fistula , major bleeding, etc.

  • ICU duration [ Time Frame: day one until discharge ] [ Designated as safety issue: No ]
  • hospital duration [ Time Frame: day one until discharge ] [ Designated as safety issue: No ]
  • SIRS [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • MODS [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 87
Study Start Date: January 2011
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: March 22, 2011
Last Updated: June 16, 2012
Health Authority: China: Ministry of Health

Keywords provided by 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

ClinicalTrials.gov processed this record on July 20, 2014