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

April 29, 2014 updated by: Zhujiang Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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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Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510280
        • Recruiting
        • Department of Hepatobiliary (I),Zhujiang Hospital
        • Principal Investigator:
          • Fan y fang, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: ureteroscopic 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.
Other Names:
  • UAPBL
No Intervention: hepatectomy group
Hepatic resection using an open approach is performed for all segments affected by biliary stenosis and the affected bile duct drainage area.Hepaticojejunostomy is performed in patients with common bile duct stenosis and in those considered to be at high risk for recurrence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
residual stone rate
Time Frame: 2 weeks
2 weeks
the stone clearance rate
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
the incidence of postoperative complications
Time Frame: one month
one month

Other Outcome Measures

Outcome Measure
Time Frame
reoperation rate
Time Frame: one month
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhujiang Hospital

Investigators

  • Principal Investigator: Fan y fang, Prof., Department of Hepatobiliary Surgery(I),Zhujiang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

March 1, 2015

Study Completion (Anticipated)

April 1, 2015

Study Registration Dates

First Submitted

April 28, 2014

First Submitted That Met QC Criteria

April 29, 2014

First Posted (Estimate)

April 30, 2014

Study Record Updates

Last Update Posted (Estimate)

April 30, 2014

Last Update Submitted That Met QC Criteria

April 29, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fanyingfang2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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