Fluid Collections Management in Severe Acute Pancreatitis
FCMSAP
Management of Sterile Fluid Collections in Patients With Severe Acute Pancreatitis:a Randomized Controlled Trial
1 other identifier
interventional
87
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 22, 2011
CompletedFirst Posted
Study publicly available on registry
March 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedJune 19, 2012
January 1, 2011
1.9 years
March 22, 2011
June 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
pancreatic infection
28 days
mortality
28 days
Secondary Outcomes (7)
inflammation parameters
28 days
intra abdominal pressure
28 days
complications
28 days
ICU duration
day one until discharge
hospital duration
day one until discharge
- +2 more secondary outcomes
Study Arms (3)
Conservative treatment
ACTIVE COMPARATORConservative treatment group with only drugs.
Continuous catheter drainage
EXPERIMENTALOnce the diameter of the fluid collection is more than 6cm, continuous catheter drainage will be applied.
Repeated aspiration
EXPERIMENTALOnce the diameter of the fluid collection is more than 6cm, aspiration is applied and draw the tube out immediately after aspiration.
Interventions
Including antibiotics,somatostatin, proton pump inhibitors and sufficient fluid resuscitation
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnant pancreatitis
- Receiving surgery or aspiration before;need of early surgery
- Infected fluid collection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nanjing University School of Medicinelead
- Jinling Hospital, Chinacollaborator
Study Sites (1)
Department of SICU, Research Institute of General Surgery Jinling Hospital,
Nanjing, Jiangsu, 210002, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of surgical ICU
Study Record Dates
First Submitted
March 22, 2011
First Posted
March 23, 2011
Study Start
January 1, 2011
Primary Completion
December 1, 2012
Last Updated
June 19, 2012
Record last verified: 2011-01