Parenchyma Resection of Cirrhotic Liver by the Clamp Crushing Technique and the Ultrasonic Dissector : Randomized Comparative Study.
Design Multicentric randomized controlled simple blinded trial comparing the clamp crushing
technique vs. the ultrasonic dissector. The trial will last 24 months with 21
Patients Patients will be enrolled in 5 university hospitals in Ile de France. Eligibility
criteria include adults with Child A liver cirrhosis undergoing partial hepatectomy (≥ 1
liver segment). Exclusion criteria include non cirrhotic patients, Child B or C cirrhosis,
portal hypertension and laparoscopic hepatectomy.
Sample size calculation was performed with the expectation of a 250 ml (one red cells pack)
difference in blood loss during parenchyma transection with a level of statistical
significance of 0.05 and a power of 0.80. These calculations indicated to include at least
60 patients in each group.
Secondary endpoints include blood loss standardized to the transection area (ml/cm²), free
margins around the tumor, postoperative liver ischemia-reperfusion injury and postoperative
Course of the study An informed consent will be obtained from each patient prior to surgery.
Each patient will be randomized the day prior to surgery. As usual, each patient will be
followed daily until he will discharge (10 days) and for 2 months at the postoperative
outcome patient clinic, which will end the study period for the patient.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intra-operative blood loss during liver transection (ml).
during liver transection
Mickael LESURTEL, MD-PhD
Assistance Publique - Hôpitaux de Paris
France: French Data Protection Authority