An interventional study of pneumatic tourniquet and No inflation in Liver Diseases, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-17.
Sponsored by University Hospital, Lille · Not applicable, Interventional, and Other
During hepatic transection, it exists a high risk of perioperative blood loss. The haemorrhage and its consequences (hypovolemia and blood transfusion) might impact the short and long term morbidity The vascular control by hepatic pedicle clamping (Pringle's maneuver) or total hepatic vascular exclusion, helps minimizing blood loss and leads to a more extensive hepatic resection.
Side effects of vascular control result of ischemia-reperfusion injury (IRI) : these reperfusion lesions results of different mechanisms than those responsible for the ischemic one. IRI cause lesions and postoperative dysfunction of the remaining liver.
Among strategies to reduce the adverse effects of IRI : ischaemic preconditioning (IPC) has been described. It can be either mechanical (intermittent hepatic pedicle clamping) or pharmacological (sevoflurane inhalation).
Short intermittent vascular occlusions in a organ might produce a resistance to a longer ischaemic period. It is certainly a physiological organ adaptation to tissue hypoxemia, which has a therapeutic potential when targeted.
During liver resection, ischaemic preconditioning is realised with periods of hepatic pedicle clamping and unclamping. It decrease morbidity and mortality and prevent postoperative hepatocellular insufficiency due to clamping and IRI at day 5.
Ischaemic preconditioning may also be applied remotely. Indeed, it is shown that short ischaemic periods in a target organ can also have a protective effect on distant others. This mechanism involve three signalling pathways : neuronal , humoral and systemic pathways.
In a previous randomized study, Kanoria and al, demonstrated that the remote ischaemic preconditioning group has shown significant lower rates of serum transaminases and higher liver clearance (spectrophotometry method) than the control group.
A latest study, measuring postoperative prothrombin rates has shown improved liver recovery due to halogen agents such as sevoflurane.
2,094 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's enrollment of 46 is close to the median of 50 across 1,328 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →University Hospital, Lille is the lead sponsor of 630 studies on the registry; 141 are open to participants now.
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Exclusion Criteria:
Procedure: pneumatic tourniquet
No inflation of the pneumatic tourniquet placed on the lower limb
Other: No inflation
a pneumatic tourniquet around 200 mmHg after venous chase of the lower limb, during 5 minutes then deflated. Repeated twice after general anaesthesia and prior to incision.
No inflation of the pneumatic tourniquet placed on the lower limb
Indocyanine green clearance
Indocyanine green clearance (%/min) by indocyanine green retention, measured with Limon pulse spectrophotometry method.
Time frame: at 5 days after liver resection
Serum transaminases rates
Time frame: at day 1,day 3 and day 5 post-hepatectomy.
Prothrombin rate
Time frame: at day 5 post-hepatectomy.
the Kidney Disease: Improving Global Outcomes (KDIGO) score
The score varies from 1 to 4.
Time frame: at day 1,day 3 and day 5 post-hepatectomy.
the Clavien & Dindo score
this classification in order to rank a post operative complications. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V)
Time frame: at day 30 post-hepatectomy
duration of stay in the hospital.
Time frame: at day 30 post-hepatectomy
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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