Ischemic Preconditioning in Major Hepatectomy (NCT00908245) | Clinical Trial Compass
CompletedPhase 3
Ischemic Preconditioning in Major Hepatectomy
France81 participantsStarted 2003-09
Plain-language summary
To evaluate the accuracy of ischemic preconditioning (IPC) as a protective maneuver against ischemia/reperfusion lesion in patients undergoing major liver resection with intermittent portal triad Clamping (IPTC).
Summary Background Data: For sake of safety and to avoid excessive blood loss during parenchymal transection, vascular inflow occlusion is an effective trick but may cause ischemic damage to the remnant liver and can lead to liver failure in case of chronic liver disease. IPTC has been proven to be superior to continuous hepatic pedicle clamping as it preserve liver remnant from severe ischemia/reperfusion lesion, so does IPC. Yet, if IPC is beneficial if liver resection is performed under IPTC has never been demonstrated in a randomised controlled trial (RCT). The investigators designed a RCT to assess the impact of IPC in patient undergoing major liver resection with intermittent vascular inflow occlusion.
Who can participate
Age range
18 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' age ≥ 18 years old,
* liver resection of 3 segments (as described by Couinaud) or more,
* posterior lesionectomy (segment VI and VII),
* liver resection only or associated with a primary digestive or biliary tumor.
* Portal vein embolisation allowed
Exclusion Criteria:
* Patients with cirrhosis,
* synchronous radiofrequency or cryotherapy ablation,
* undergoing segmentectomy,
* left lateral lesionectomy or laparoscopic liver resection,
* pregnant women
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
The primary outcome was a 50% reduction of transaminases (AST, ALT) level on postoperative day 1 in the preconditioning group.