Pancreatitis
Conditions
Keywords
pancreatitis, early stage, mini-invasive abdominal drainage
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.
Interventions
OTHEREarly 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;
OTHERLate 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;
Sponsors
RenJi Hospital
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rates of ACS in 28 days since outbreaks | 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
| Measure | Time frame | Description |
|---|---|---|
| Rates of surgical interfere, MODS or death in 6 months since outbreaks | 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; |
Countries
China
Contacts
Primary Contacterzhen Chen, PhD
Backup Contactenqiang Mao, PhD
Outcome results
None listed