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

Pancreatitis, Acute Necrotizing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02133014
• Other study ID #: Fanyingfang1
• Status: Recruiting
• Phase: N/A
• First received: April 28, 2014
• Last updated: May 3, 2014
• Start date: April 2014
• Est. completion date: April 2015

Study information

• Verified date: April 2014
• Source: Zhujiang Hospital
• Contact: Wang li qing, doctor
• Phone: +86-02062783391
• Email: wliqing07[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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-?score 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatitis
• Pancreatitis, Acute Necrotizing

Intervention

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

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.

Locations

Country	Name	City	State
China	Department of Hepatobiliary Surgery(I),Zhujiang Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	hospital stay		participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No
Primary	mortality		one year	Yes
Secondary	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	Yes