Clinical trial NCT02127242: Laparoscope Combined Ureteroscopic Air-pressure Ballistic Lithotripsy to Treat Patients With Hepatolithiasis
Official title: The Study of Laparoscope Combined Ureteroscopic Air-pressure Ballistic Lithotripsy to Treat Patients With Hepatolithiasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cholelithiasis
Keywords: hepatolithiasis
ureteroscope
air-pressure ballistic lithotripsy
hepatectomy
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2014-04-30
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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Eligibility criteria: 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.

Primary outcomes:
measure: residual stone rate
timeFrame: 2 weeks
measure: the stone clearance rate
timeFrame: 2 weeks
Secondary outcomes:
measure: the incidence of postoperative complications
timeFrame: one month
Other outcomes:
measure: reoperation rate
timeFrame: one month
Locations:
city: Guangzhou
country: China
facility: Department of Hepatobiliary (I),Zhujiang Hospital
state: Guangdong
Study officials:
affiliation: Department of Hepatobiliary Surgery(I),Zhujiang Hospital
name: Fan y fang, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.