Parenchyma Resection of Cirrhotic Liver by the Clamp Crushing Technique and the Ultrasonic Dissector

Study Overview
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Brief Summary
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To identify the most efficient parenchyma transection technique for cirrhotic liver resection between the clamp crushing technique and the ultrasonic dissector. Primary endpoint is intra-operative blood loss during liver transection (ml). Expected results and implications: If one of the technique is better than the other, surgical teams could prefer it to minimize the morbidity of liver resection in cirrhotic patients.

Detailed Description
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Design Multicentric randomized controlled simple blinded trial comparing the clamp crushing technique vs. the ultrasonic dissector. The trial will last 24 months with 21 month-inclusion time. 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 complications. 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.

Official Title
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Parenchyma Resection of Cirrhotic Liver by the Clamp Crushing Technique and the Ultrasonic Dissector : Randomized Comparative Study.

Conditions
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Liver Cirrhosis, Liver Neoplasms, Carcinoma, Hepatocellular

Intervention / Treatment
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* Device: clamp crushing technique
* Device: ultrasonic dissector


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Child A liver cirrhosis Partial hepatectomy (≥ 1 segment). Patient at least 18 years of age Exclusion Criteria: Non cirrhotic patient Child B or C cirrhosis Portal hypertension Laparoscopic hepatectomy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Liver transection by clamp crushing technique | Device: clamp crushing technique<br>* Liver transection during hepatectomy by clamp crushing technique<br>|
| Other: 2<br>Liver transection by the ultrasonic dissector | Device: ultrasonic dissector<br>* Liver transection during hepatectomy by the ultrasonic dissector<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-operative blood loss during liver transection (ml). |  | during liver transection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-operative blood loss standardized to the transection area (ml/cm²) |  | during liver transection | 
| free margins around the tumor |  | during liver transection | 
| postoperative liver ischemia-reperfusion injury (post-operative peak of transaminases) |  | daily until the discharge of the patient | 
| 60-day postoperative complications |  | 2 months after the liver transection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver cirrhosis, Hepatectomy, Liver parenchyma transection, Randomized controlled trial