Parenchyma Resection of Cirrhotic Liver by the Clamp Crushing Technique and the Ultrasonic Dissector (SECCI)
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|ClinicalTrials.gov Identifier: NCT00763776|
Recruitment Status : Terminated (difficulty for the patient recruiting)
First Posted : October 1, 2008
Last Update Posted : February 27, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Liver Cirrhosis Liver Neoplasms Carcinoma, Hepatocellular||Device: clamp crushing technique Device: ultrasonic dissector||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Parenchyma Resection of Cirrhotic Liver by the Clamp Crushing Technique and the Ultrasonic Dissector : Randomized Comparative Study.|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||September 2010|
Liver transection by clamp crushing technique
Device: clamp crushing technique
Liver transection during hepatectomy by clamp crushing technique
Liver transection by the ultrasonic dissector
Device: ultrasonic dissector
Liver transection during hepatectomy by the ultrasonic dissector
- Intra-operative blood loss during liver transection (ml). [ Time Frame: during liver transection ]
- Intra-operative blood loss standardized to the transection area (ml/cm²) [ Time Frame: during liver transection ]
- free margins around the tumor [ Time Frame: during liver transection ]
- postoperative liver ischemia-reperfusion injury (post-operative peak of transaminases) [ Time Frame: daily until the discharge of the patient ]
- 60-day postoperative complications [ Time Frame: 2 months after the liver transection ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00763776
|Clichy, France, 92 118|
|Principal Investigator:||Mickael LESURTEL, MD-PhD||Assistance Publique - Hôpitaux de Paris|