Fluid Collections Management in Severe Acute Pancreatitis

Acute Pancreatitis Clinical Trial

— FCMSAP  

Official title:

Management of Sterile Fluid Collections in Patients With Severe Acute Pancreatitis:a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01321060
• Other study ID #: RIGS
• Status: Recruiting
• Phase: N/A
• First received: March 22, 2011
• Last updated: June 16, 2012
• Start date: January 2011

Study information

• Verified date: January 2011
• Source: Nanjing University School of Medicine
• Contact: Weiqin Li, Dr
• Phone: +86-025-80860066
• Email: kkb9832[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 87
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pancreatic Fluid Collection
• Acute Pancreatitis
• Pancreatitis

Intervention

Procedure:
• Aspiration

• Catheter drainage

Drug:
• Conservative treatment
Including antibiotics,somatostatin, proton pump inhibitors and sufficient fluid resuscitation

Locations

Country	Name	City	State
China	Department of SICU, Research Institute of General Surgery Jinling Hospital,	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Nanjing University School of Medicine	Jinling Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pancreatic infection		28 days	Yes
Primary	mortality		28 days	No
Secondary	inflammation parameters		28 days	No
Secondary	intra abdominal pressure		28 days	No
Secondary	complications	intestinal fistula , major bleeding, etc.	28 days	Yes
Secondary	ICU duration		day one until discharge	No
Secondary	hospital duration		day one until discharge	No
Secondary	SIRS		28 days	No
Secondary	MODS		28 days	No