Skip to content

Laparoscope Combined Ureteroscopic Air-pressure Ballistic Lithotripsy to Treat Patients With Hepatolithiasis

The Study of Laparoscope Combined Ureteroscopic Air-pressure Ballistic Lithotripsy to Treat Patients With Hepatolithiasis

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02127242
Enrollment
60
Registered
2014-04-30
Start date
2014-04-30
Completion date
2015-04-30
Last updated
2014-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholelithiasis

Keywords

hepatolithiasis, ureteroscope, air-pressure ballistic lithotripsy, hepatectomy

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. .

Interventions

PROCEDUREureteroscopic air-pressure ballistic lithotripsy

In case of large, hard or impacted stones ureteroscopic air-pressure ballistic lithotripter is used for fragmentation. The probe of the lithotripter target towards the stone and then fragmented.

Sponsors

Zhujiang Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
residual stone rate2 weeks
the stone clearance rate2 weeks

Secondary

MeasureTime frame
the incidence of postoperative complicationsone month

Other

MeasureTime frame
reoperation rateone month

Countries

China

Contacts

Primary ContactWang Li qing, Doctor
wliqing07@gmail.com+86-02062783391

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026