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

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

Study Overview

• Status: Unknown
• Conditions: Pancreatitis
• Intervention / Treatment: Other: Early stage abdominal drainage; Other: Late stage abdominal drainage

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 20000
      • Recruiting
      • Ruijin
      • Contact: erzhen Chen, PhD; Phone Number: 665520 66370045; Email: chenerzhen@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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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

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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;	Other: Early stage abdominal drainage; Ultrasound/CT/GUS guided abdominocentesis and drainage with single-chamber deep venous catheters shoule be implemented and the catheter should be removed when abdominal drainage flow≤100ml in two successive days;
Other: 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;	Other: Late stage abdominal drainage; Despite that it matches one of the cirteria as the study group:1．Intravesical pressure≥20cmH2O or 2．CT scan: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;

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of ACS in 28 days since outbreaks	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;	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of surgical interfere, MODS or death in 6 months since outbreaks	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;	6 months

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Collaborators: RenJi Hospital
• Investigators: Study Director: erzhen Chen, Professor, Emergency intensive care unit of Ruijin Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Anticipated): September 1, 2016
• Study Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: November 11, 2013
• First Submitted That Met QC Criteria: December 1, 2013
• First Posted (Estimate): December 6, 2013

Study Record Updates

• Last Update Posted (Estimate): December 6, 2013
• Last Update Submitted That Met QC Criteria: December 1, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: pancreatitis; early stage; mini-invasive abdominal drainage
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis
• Other Study ID Numbers: SAP bundle-abdominal drainage