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Clinical Trial Summary

Objective:the purpose of this study is to investigate the efficacy,feasibility,reliability,and safety of laparoscope combined air-pressure ballistic lithotripsy in the treatment of patients with bile duct stones.

Methods:We are going to select 60 patients diagnosed with hepatolithiasis who carry on the treatment in our hospital from April 2014 to April 2015.According to the unified inclusion and exclusion criteria,the patients are divided into the experimental group and the control group.The experimental group use the treatment of laparoscope combine with air-pressure ballistic lithotripsy to treat hepatolithiasis,while the control group treat the patients with hepatolithiasis with the method of lobectomy and segmental resection of liver.Contrastive analyzed two group of patients' clinical care effects.

Research hypothesis:according to compare two groups' duration of surgery,blood loss,postoperative complication rate,hospital stay,the stone clearance rate,,the residual stone rate,reoperation rate etc.We suppose that the clinical results of the experimental group are superior to the control group,difference is statistically significant(P<0.05).So we can draw the conclusion that the method of laparoscope combined air-pressure ballistic lithotripsy is useful in treatment of patients with hepatolithiasis.


Clinical Trial Description

To select 60 patients diagnosed with hepatolithiasis who carry on the treatment in our hospital from April 2014 to April 2015.According to the unified inclusion and exclusion criteria,the patients are divided into the experimental group and the control group.The experimental group use the treatment of laparoscope combine with air-pressure ballistic lithotripsy to treat hepatolithiasis,while the control group treat the patients with hepatolithiasis with the method of lobectomy and segmental resection of liver.

The experimental group performed under the situation of tracheal intubation general,placing the ureteroscope into common bile duct and exploring the bile duct after laparoscopic cholecystectomy and choledochotomy.Associated with air-pressure ballistic lithotripsy once discover bile duct stones and retrieve the rubble by flowing it out.To stone's diameter lower than 5 mm,use lithotomy forceps pull it out.Examining the bottom of common bile duct,ensuring that it will not obstructed.Last,placing the T-tube continuous drainage the residual stones.The control group using the way of hepatectomy.Choosing suitable surgical options according to the stones' location and associating with choledochoenterostomy if needed.

Contrastive analyse two groups' clinical indicators,such as operation time,blood loss during the surgery,hospital stay,the stone clearance rate,the residual stone rate,the incidence of postoperative complications and so on. ;


Study Design

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


Related Conditions & MeSH terms


NCT number NCT02127242
Study type Interventional
Source Zhujiang Hospital
Contact Wang Li qing, Doctor
Phone +86-02062783391
Email wliqing07@gmail.com
Status Recruiting
Phase N/A
Start date April 2014
Completion date April 2015

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