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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02002793
Recruitment Status : Unknown
Verified December 2013 by Erzhen Chen, Ruijin Hospital.
Recruitment status was:  Recruiting
First Posted : December 6, 2013
Last Update Posted : December 6, 2013
Sponsor:
Collaborator:
RenJi Hospital
Information provided by (Responsible Party):
Erzhen Chen, 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.

Condition or disease Intervention/treatment Phase
Pancreatitis Other: Early stage abdominal drainage Other: Late stage abdominal drainage Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of Early Stage Mini-invasive Abdominal Drainage on Complications and Prognosis of SAP
Study Start Date : August 2013
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
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;

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;




Primary Outcome Measures :
  1. Rates of ACS in 28 days since outbreaks [ Time Frame: 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 :
  1. Rates of surgical interfere, MODS or death in 6 months since outbreaks [ Time Frame: 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;



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02002793


Contacts
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Contact: erzhen Chen, PhD 64370045 ext 665520 chenerzhen@hotmail.com
Contact: enqiang Mao, PhD 64370045 ext 665520 maoenqiang@hotmail.com

Locations
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China, Shanghai
Ruijin Recruiting
Shanghai, Shanghai, China, 20000
Contact: erzhen Chen, PhD    66370045 ext 665520    chenerzhen@hotmail.com   
Sponsors and Collaborators
Ruijin Hospital
RenJi Hospital
Investigators
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Study Director: erzhen Chen, Professor Emergency intensive care unit of Ruijin Hospital
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Responsible Party: Erzhen Chen, Professor, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT02002793    
Other Study ID Numbers: SAP bundle-abdominal drainage
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: December 6, 2013
Last Verified: December 2013
Keywords provided by Erzhen Chen, Ruijin Hospital:
pancreatitis
early stage
mini-invasive abdominal drainage
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases