Cholelithiasis Clinical Trial
Official title:
The Study of Laparoscope Combined Ureteroscopic Air-pressure Ballistic Lithotripsy to Treat Patients With Hepatolithiasis
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | April 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Patients with hepatolithiasis; - Patients with hepatolithiasis and extrahepatic bile duct stones or gallbladder stones; - Patients with hepatolithiasis and acute cholangitis whose inflammation subside more than one month by conservative therapy. - Regularly visiting our hospital; - Willing to comply with all study procedures and provided signed and dated informed consent. Exclusion Criteria: - Simply gallbladder stones; - Hepatolithiasis with carol's disease; - Hepatolithiasis with bile duct carcinoma; - patients with the clinical performances of severe cholangitis; - patients with biliary stricture obviously; - patients with heart,lungs,hepatic or renal dysfunction. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Department of Hepatobiliary (I),Zhujiang Hospital | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Zhujiang Hospital |
China,
Farooq Qadri SJ, Khan M, Khan N. Use of pneumatic lithotripsy for managing difficult CBD calculi. Int J Surg. 2011;9(1):59-62. doi: 10.1016/j.ijsu.2010.08.009. Epub 2010 Sep 16. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | reoperation rate | one month | No | |
Primary | residual stone rate | 2 weeks | No | |
Primary | the stone clearance rate | 2 weeks | No | |
Secondary | the incidence of postoperative complications | one month | Yes |
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