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

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Unknown

Conditions

Pancreatitis

Treatments

Other: Late stage abdominal drainage
Other: Early stage abdominal drainage

Study type

Interventional

Funder types

Other

Identifiers

NCT02002793
SAP bundle-abdominal drainage

Details and patient eligibility

About

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

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

40 participants in 2 patient groups

Early stage abdominal drainage
Other group
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;
Treatment:
Other: Early stage abdominal drainage
Late stage abdominal drainage
Other group
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;
Treatment:
Other: Late stage abdominal drainage

Trial contacts and locations

1

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Central trial contact

erzhen Chen, PhD; enqiang Mao, PhD

Data sourced from clinicaltrials.gov

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