The Study of Laparoscopic-assisted Percutaneous Catheter-directed Drainage to Treat Early Severe Acute Pancreatitis

The Study of Laparoscopic-assisted Percutaneous Catheter-directed Drainage to Treat Early Severe Acute Pancreatitis in Chinese Population.

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.

Study Overview

• Status: Unknown
• Conditions: Pancreatitis, Acute Necrotizing
• Intervention / Treatment: Procedure: laparoscopic-assisted percutaneous catheter drainage; Drug: 0.5% 5-fluorouracil normal saline

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wang li qing, doctor; Phone Number: +86-02062783391; Email: wliqing07@gmail.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510280
      • Recruiting
      • Department of Hepatobiliary Surgery(I),Zhujiang Hospital
      • Principal Investigator: Fan y fang, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: surgical operation therapy; 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.	Procedure: laparoscopic-assisted percutaneous catheter drainage; 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; Other Names: surgical therapy; Drug: 0.5% 5-fluorouracil normal saline; 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.; Other Names: 5-FU; f5U
No Intervention: conventional therapy; using the method of conventional conservative therapy without surgical management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
mortality	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence of local Complications	the local complications include:pancreatic necrosis,pancreatic abscess,pancreatic pseudocyst etc.	within the first 30 days (plus or minus 3 days) after surgery

Other Outcome Measures

Outcome Measure	Time Frame
hospital stay	participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Collaborators and Investigators

• Sponsor: Zhujiang Hospital
• Investigators: Principal Investigator: Fan y fang, Prof., Department of Hepatobiliary Surgery(I),Zhujiang Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Anticipated): April 1, 2015
• Study Completion (Anticipated): April 1, 2015

Study Registration Dates

• First Submitted: April 28, 2014
• First Submitted That Met QC Criteria: May 3, 2014
• First Posted (Estimate): May 7, 2014

Study Record Updates

• Last Update Posted (Estimate): May 7, 2014
• Last Update Submitted That Met QC Criteria: May 3, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: surgery; pancreatitis; laparoscopic; drainage
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Pancreatitis, Acute Necrotizing; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Fluorouracil
• Other Study ID Numbers: Fanyingfang1