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

NCT ID: NCT02002793

Last Updated: 2013-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2017-08-31

Brief Summary

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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

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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.

Conditions

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Pancreatitis

Keywords

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pancreatitis early stage mini-invasive abdominal drainage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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;

Group Type OTHER

Early stage abdominal drainage

Intervention Type OTHER

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;

Group Type OTHER

Late stage abdominal drainage

Intervention Type OTHER

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;

Interventions

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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;

Intervention Type 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;

Intervention Type OTHER

Eligibility Criteria

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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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Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role collaborator

Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Erzhen Chen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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erzhen Chen, Professor

Role: STUDY_DIRECTOR

Emergency intensive care unit of Ruijin Hospital

Locations

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Ruijin

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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erzhen Chen, PhD

Role: CONTACT

Phone: 64370045

Email: [email protected]

enqiang Mao, PhD

Role: CONTACT

Phone: 64370045

Email: [email protected]

Facility Contacts

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erzhen Chen, PhD

Role: primary

Other Identifiers

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SAP bundle-abdominal drainage

Identifier Type: -

Identifier Source: org_study_id