Research of the Key Technology and Standardization of Minimal Invasive Treatment for Hepatolithiasis (NCT01563510) | Clinical Trial Compass
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Research of the Key Technology and Standardization of Minimal Invasive Treatment for Hepatolithiasis
China100 participantsStarted 2012-01
Plain-language summary
The purpose of this research is to investigate the key technology and the related issues of minimal invasive treatment for hepatolithiasis and to build new methods of minimal invasive operation for hepatolithiasis. The validity, feasibility and limitations of the laparoscopic operation were assessed objectively through our clinical prospective study. The technique points, indications and contraindications were summarized to evaluate the status and role of minimal invasive laparoscopic operation in the treatment of hepatolithiasis.
Who can participate
Age range
18 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 regional stones distributed in a segment, lobe or half liver, combined or not combined with extrahepatic biliary calculi, hepatic parenchymal atrophy or fibrosis in the lesion region
. Liver function \> Child-pugh level B, no severe biliary cirrhosis, ICG ≤ 15%, the residual liver volume and standard liver volume ratio ≥ 40%
. Patients with good general condition, the conditions of open Anatomical Hepatectomy were achieved
Exclusion criteria
. Written informed consent
. Age: older than 70 years old, younger than 18 years old
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.
What they're measuring
1
Number of participants with residual stones or cholangitis symptoms
. Patients with bad general condition or important organ lesions, liver resection could not be tolerated
. Complicated case needed to get emergency operation
. Combined with severe liver atrophy hypertrophy syndrome, hepatic portal transposition or hilar biliary fibrosis / stenosis
. Combined with severe biliary cirrhosis and portal hypertension, severe varicose of hepatic portal vein , hepatic insufficiency
. Diagnosed with cholangiocellular carcinoma intraoperatively or by postoperative pathology
. Contraindication of laparoscopy: Combined with complicated acute cholangitis, repeated biliary tract operation, heavy intra-abdominal adhesion, Trocar can not be placed in. Artificial pneumoperitoneum could not be tolerated