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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | Liver transection by clamp crushing technique |
|
| 2 | Other | Liver transection by the ultrasonic dissector |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clamp crushing technique | Device | Liver transection during hepatectomy by clamp crushing technique |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Intra-operative blood loss during liver transection (ml). | during liver transection |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mickael LESURTEL, MD-PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital BEAUJON | Clichy | 92 118 | France |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D008113 | Liver Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ultrasonic dissector |
| Device |
Liver transection during hepatectomy by the ultrasonic dissector |
|
| daily until the discharge of the patient |
| 60-day postoperative complications | 2 months after the liver transection |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |