The Study of Laparoscopic-assisted Percutaneous Catheter-directed Drainage to Treat Early Severe Acute Pancreatitis
Primary Purpose
Pancreatitis, Acute Necrotizing
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
laparoscopic-assisted percutaneous catheter drainage
0.5% 5-fluorouracil normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatitis, Acute Necrotizing focused on measuring pancreatitis, laparoscopic, drainage, surgery
Eligibility Criteria
Inclusion Criteria:Possessing the clinical performance and biochemical changes of acute pancreatitis,as well as one of the following items:
- organ dysfunction(one organ or multiple organs)
- local complications(pancreatic necrosis;pancreatic abscess;pancreatic pseudocyst);Ronson score of ≥3;
- APACHE-Ⅱscore of ≥8;
- Balthazar CT grade D or grade E.
Exclusion Criteria:
- mild acute pancreatitis;
- chronic acute pancreatitis;
- on admission has received surgical treatment;
- pregnant and lactating women ;combined with heart,lung,liver,kidney severe primary disease;psychopath;
- malignant tumor
- immunocompromised state.
Sites / Locations
- Department of Hepatobiliary Surgery(I),Zhujiang HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
surgical operation therapy
conventional therapy
Arm Description
Using the method of laparoscopic-assisted percutaneous catheter drainage of SAP.After the surgery,patient's cavity are continuously douched by catheter using 0.5% 5-fluorouracil normal saline.
using the method of conventional conservative therapy without surgical management.
Outcomes
Primary Outcome Measures
mortality
Secondary Outcome Measures
the incidence of local Complications
the local complications include:pancreatic necrosis,pancreatic abscess,pancreatic pseudocyst etc.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02133014
Brief Title
The Study of Laparoscopic-assisted Percutaneous Catheter-directed Drainage to Treat Early Severe Acute Pancreatitis
Official Title
The Study of Laparoscopic-assisted Percutaneous Catheter-directed Drainage to Treat Early Severe Acute Pancreatitis in Chinese Population.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
April 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhujiang Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to analyze the effect of laparoscopic-assisted percutaneous catheter drainage of early SAP(severe acute pancreatitis).We are going to select 60 cases SAP patients from April 2014 to April 2015 who carry on the treatment in our hospital,and divide into the experimental group and control group under respect the wishes of patient in the case.The experimental group use the method of laparoscopic-assisted percutaneous drainage to carry on the treatment,the control group patients use conventional conservative therapy to carry on the treatment.Contrastive analyze two groups of patients clinical care effects.
Research hypothesis:according to compare the mortality,the incidence of complications ,hospital stay and other research indicators of two groups .It is supposed that the research indicators of experimental group are lower than the control group ,difference was statistically significant(P<0.05).We can draw the conclusion that the method of laparoscopic-assisted percutaneous catheter drainage of early SAP is useful and deserve to be promoted on clinical.
Detailed Description
According to the unified inclusion and exclusion criteria,We are going to select 60 cases SAP patients who carry on the treatment in our hospital from April 2014 to April 2015,and divide into the experimental group and control group under respect the wishes of patients.
The experimental group use the method of laparoscopic-assisted percutaneous catheter-directed drainage of SAP.According to different causes,.For patients with simple gallbladder stones,it is going to carry out by laparoscopic cholecystectomy or cholecystotomy.For patients with both gallbladder and common bile duct stones,common bile duct exploration is performed.Removing necrotic pancreatic organizations and putting the catheter around the region of pancreas.After the surgery,patient's cavity are continuously douched by catheter using 0.5% 5-fluorouracil normal saline.The postoperation therapeutic program is same as the control group.
The control group use the method of conventional conservative therapy without surgical management,the principles of treatment include:(1)fasting,insert gastric tube,gastrointestinal decompression;(2)complement of blood volume,keeping water ,electrolyte and acid base balance;(3)inhibiting pancreatic enzyme and acid secretion;(4)using broad-spectrum antibiotic at the early phase;(5)improving microcirculation,dextrans and FuFangdanshen by IV;(6)early parenteral nutrition;(7)treatment by chinese herbs;(8)strengthen the function of important organs.
Contrastive analyse two groups of patient's mortality,the incidence of complications,hospital stay,laboratory tests and other research indicators.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis, Acute Necrotizing
Keywords
pancreatitis, laparoscopic, drainage, surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
surgical operation therapy
Arm Type
Experimental
Arm Description
Using the method of laparoscopic-assisted percutaneous catheter drainage of SAP.After the surgery,patient's cavity are continuously douched by catheter using 0.5% 5-fluorouracil normal saline.
Arm Title
conventional therapy
Arm Type
No Intervention
Arm Description
using the method of conventional conservative therapy without surgical management.
Intervention Type
Procedure
Intervention Name(s)
laparoscopic-assisted percutaneous catheter drainage
Other Intervention Name(s)
surgical therapy
Intervention Description
Removing necrotic pancreatic organizations and putting the catheter around the region of pancreas.After the surgery,patient's cavity are continuously douched by catheter using 0.5% 5-fluorouracil normal saline
Intervention Type
Drug
Intervention Name(s)
0.5% 5-fluorouracil normal saline
Other Intervention Name(s)
5-FU, f5U
Intervention Description
On the one hand,0.5% 5-fluorouracil normal saline directly inhibit DNA synthesis of pancreatic acinar cells which result in the synthesis of amylopsin of and trypsase is restrained.On the other hand,it can induce pancreatic cells apoptosis and alleviate pancreatic necrosis.
Primary Outcome Measure Information:
Title
mortality
Time Frame
one year
Secondary Outcome Measure Information:
Title
the incidence of local Complications
Description
the local complications include:pancreatic necrosis,pancreatic abscess,pancreatic pseudocyst etc.
Time Frame
within the first 30 days (plus or minus 3 days) after surgery
Other Pre-specified Outcome Measures:
Title
hospital stay
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:Possessing the clinical performance and biochemical changes of acute pancreatitis,as well as one of the following items:
organ dysfunction(one organ or multiple organs)
local complications(pancreatic necrosis;pancreatic abscess;pancreatic pseudocyst);Ronson score of ≥3;
APACHE-Ⅱscore of ≥8;
Balthazar CT grade D or grade E.
Exclusion Criteria:
mild acute pancreatitis;
chronic acute pancreatitis;
on admission has received surgical treatment;
pregnant and lactating women ;combined with heart,lung,liver,kidney severe primary disease;psychopath;
malignant tumor
immunocompromised state.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wang li qing, doctor
Phone
+86-02062783391
Email
wliqing07@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fan y fang, Prof.
Organizational Affiliation
Department of Hepatobiliary Surgery(I),Zhujiang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Hepatobiliary Surgery(I),Zhujiang Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510280
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fan y fang, Prof.
12. IPD Sharing Statement
Citations:
PubMed Identifier
9684824
Citation
Echenique AM, Sleeman D, Yrizarry J, Scagnelli T, Guerra JJ Jr, Casillas VJ, Huson H, Russell E. Percutaneous catheter-directed debridement of infected pancreatic necrosis: results in 20 patients. J Vasc Interv Radiol. 1998 Jul-Aug;9(4):565-71. doi: 10.1016/s1051-0443(98)70323-9.
Results Reference
result
Learn more about this trial
The Study of Laparoscopic-assisted Percutaneous Catheter-directed Drainage to Treat Early Severe Acute Pancreatitis
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