Effects of Early Stage Mini-invasive Abdominal Drainage on Complications and Prognosis of SAP

Not Applicable

• Conditions: Pancreatitis
• Interventions: Other: Late stage abdominal drainage; Other: Early stage abdominal drainage

• Registration Number: NCT02002793
• Lead Sponsor: Ruijin Hospital

Brief Summary

This study aims to standardized the process of mini-invasive abdominal draniage of SAP in early stage.To determine the indications and occasion.

Detailed Description

Pancreatitis associated ascetic fluids(PAAF) gather with the beginning of SAP and induced IAP(intra-abdominal pressure) increasement.With an excess of 12mmHg ,IAP presents as IAH(intra-abdominal hypertension) and when a ≥20mmHg IAP accompanied with at least one organ's dysfunction it is ACS(abdominal compartment syndrome).Previous recommended theraphy of ACS is laparotomy.However,with inherited advantages such as ease-to-operate and minimal invassiveness, early stage mini-invasive abdominal drainage therapies , for example, percutaneous catheter drainage(PCD) instructed by ultrasound or CT ,have shown a promised future in recent years. It is reported that patients acquired PCD decreased 81% in operation rate compared to those who did not and had lower mortality rate. Whereas, the operation flow of early stage mini-invasive abdominal drainage remains controversial, and whose validity calls for evidence from large-scale clinical trials.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-11-11
• Status Verified: 2013-12
• Study First Submitted QC: 2013-12-01
• Last Update Submitted: 2013-12-01
• Study First Posted: 2013-12-06
• Last Update Posted: 2013-12-06
• Primary Completion: 2016-09
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.Diagnosis of pancreatitis 2.Onset of abdominal pain within 72h 3.Moderate severe or severe AP according to Atlanta criteria revisited in 2012 4.Intravesical pressure≥20cmH2O 4.CT images:acute peripancreatic liquid collection

Exclusion Criteria

1.Pregnancy 2.Heart function: NYHA >II 3.Pacemaker implantation 4.COPD 5.CKD 6.Pre-existing disease with life expectancy < 3 months 7.CT images:No acute peripancreatic liquid collection 8.Intravesical pressure>25cmH2O 9.At least one organ'S newly emerged dysfunction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Late stage abdominal drainage	Late stage abdominal drainage	Despite that it matches one of the cirteria as the study group:1．Intravesical pressure≥20cmH2O or 2．CT images:acute peripancreatic liquid collection, the patients continue acquire prearranged integrative treatment and will not accept early stage abdominal drainage until any of the followings emerge:1.Intra-abdominal apartment syndrome; 2. Pancreatic pseudocyst;3. Pancreatic or peripancreatic necrosis;
Early stage abdominal drainage	Early stage abdominal drainage	SAP patients who matches one of the following criteria:1．Intravesical pressure≥20cmH2O or 2.CT images:acute peripancreatic liquid collection should have early stage abdominal drainage immediately;

Primary Outcome Measures

Name	Time	Method
Rates of ACS in 28 days since outbreaks	28 days	Time of first attacks of these situations that have to be surgically interfered in 28 days since onsets: ACS or pancreatic necrosis, abdominal hemorrhage, pancreatic abscess or pancreatic pseudocyst which brings symptoms or complications or increase in size;rates of organs' dysfunction, abdominal infection and reuse of drainage;

Secondary Outcome Measures

Name	Time	Method
Rates of surgical interfere, MODS or death in 6 months since outbreaks	6 months	Rates of mortality or organs' dysfunction; rates of complications, including: pancreatic leakage, pancreatic pseudocysts in need of surgical interfere, pancreatic abscess, bile duct stricture and pancreatic insufficiency; times of surgery, hospital stay, time in ICU and hospitalization expense;

Trial Locations

Locations (1)

Ruijin; 🇨🇳 Shanghai, Shanghai, China