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

Primary Purpose

Pancreatitis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Early stage abdominal drainage
Late stage abdominal drainage
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatitis focused on measuring pancreatitis, early stage, mini-invasive abdominal drainage

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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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Sites / Locations

  • RuijinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Early stage abdominal drainage

Late stage abdominal drainage

Arm Description

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;

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;

Outcomes

Primary Outcome Measures

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;

Secondary Outcome Measures

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;

Full Information

First Posted
November 11, 2013
Last Updated
December 1, 2013
Sponsor
Ruijin Hospital
Collaborators
RenJi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02002793
Brief Title
Effects of Early Stage Mini-invasive Abdominal Drainage on Complications and Prognosis of SAP
Official Title
Effects of Early Stage Mini-invasive Abdominal Drainage on Complications and Prognosis of SAP
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
Collaborators
RenJi Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis
Keywords
pancreatitis, early stage, mini-invasive abdominal drainage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early stage abdominal drainage
Arm Type
Other
Arm Description
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;
Arm Title
Late stage abdominal drainage
Arm Type
Other
Arm Description
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;
Intervention Type
Other
Intervention Name(s)
Early stage abdominal drainage
Intervention Description
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;
Intervention Type
Other
Intervention Name(s)
Late stage abdominal drainage
Intervention Description
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 Measure Information:
Title
Rates of ACS in 28 days since outbreaks
Description
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;
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Rates of surgical interfere, MODS or death in 6 months since outbreaks
Description
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;
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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 - 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 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
erzhen Chen, PhD
Phone
64370045
Ext
665520
Email
chenerzhen@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
enqiang Mao, PhD
Phone
64370045
Ext
665520
Email
maoenqiang@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
erzhen Chen, Professor
Organizational Affiliation
Emergency intensive care unit of Ruijin Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Ruijin
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
20000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
erzhen Chen, PhD
Phone
66370045
Ext
665520
Email
chenerzhen@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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