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

NCT02133014 | Unknown DMC

• 1 other identifier: Fanyingfang1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatitis, Acute Necrotizing

Keywords

pancreatitis; laparoscopic; drainage; surgery

Outcome Measures

Primary Outcomes (1)

• mortality

  one year

Secondary Outcomes (1)

• the incidence of local Complications

  within the first 30 days (plus or minus 3 days) after surgery

Other Outcomes (1)

• hospital stay

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

Study Arms (2)

surgical operation therapy

EXPERIMENTAL

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; Drug: 0.5% 5-fluorouracil normal saline

conventional therapy

NO INTERVENTION

using the method of conventional conservative therapy without surgical management.

Interventions

laparoscopic-assisted percutaneous catheter drainage PROCEDURE

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

Also known as: surgical therapy

surgical operation therapy

0.5% 5-fluorouracil normal saline DRUG

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.

Also known as: 5-FU, f5U

surgical operation therapy

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Department of Hepatobiliary Surgery(I),Zhujiang Hospital

Guangzhou, Guangdong, 510280, China

RECRUITING

Related 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. doi: 10.1016/s1051-0443(98)70323-9.

  PMID: 9684824 RESULT

MeSH Terms

Conditions

Pancreatitis, Acute Necrotizing; Pancreatitis

Interventions

Fluorouracil

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Fan y fang, Prof.

  Department of Hepatobiliary Surgery(I),Zhujiang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang li qing, doctor

CONTACT

+86-02062783391; wliqing07@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2014
• First Posted: May 7, 2014
• Study Start: April 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: May 7, 2014

Record last verified: 2014-04

Locations

CN (1)