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

NCT02002793 | Unknown DMC

• 1 other identifier: SAP bundle-abdominal drainage
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatitis

Keywords

pancreatitis; early stage; mini-invasive abdominal drainage

Outcome Measures

Primary Outcomes (1)

• 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;

  28 days

Secondary Outcomes (1)

• Rates of surgical interfere, MODS or death in 6 months since outbreaks

  6 months

Study Arms (2)

Early stage abdominal drainage

OTHER

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

Late stage abdominal drainage

OTHER

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

Interventions

Early stage abdominal drainage 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;

Early stage abdominal drainage

Late stage abdominal drainage 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;

Late stage abdominal drainage

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead
• RenJi Hospital: collaborator

Study Sites (1)

Ruijin

Shanghai, Shanghai Municipality, 20000, China

RECRUITING

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Officials

• erzhen Chen, Professor

  Emergency intensive care unit of Ruijin Hospital

  STUDY DIRECTOR

Central Study Contacts

erzhen Chen, PhD

CONTACT

64370045; chenerzhen@hotmail.com

enqiang Mao, PhD

CONTACT

64370045; maoenqiang@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 11, 2013
• First Posted: December 6, 2013
• Study Start: August 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: August 1, 2017
• Last Updated: December 6, 2013

Record last verified: 2013-12

Locations

CN (1)