Laparoscope Combined Ureteroscopic Air-pressure Ballistic Lithotripsy to Treat Patients With Hepa… (NCT02127242) | Clinical Trial Compass
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Laparoscope Combined Ureteroscopic Air-pressure Ballistic Lithotripsy to Treat Patients With Hepatolithiasis
China60 participantsStarted 2014-04
Plain-language 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.
Who can participate
Age range
20 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.