Viewing Study NCT02002793


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Study NCT ID: NCT02002793
Status: UNKNOWN
Last Update Posted: 2013-12-06
First Post: 2013-11-11
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Effects of Early Stage Mini-invasive Abdominal Drainage on Complications and Prognosis of SAP
Sponsor: Ruijin Hospital
Organization:

Study Overview

Official Title: Effects of Early Stage Mini-invasive Abdominal Drainage on Complications and Prognosis of SAP
Status: UNKNOWN
Status Verified Date: 2013-12
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: