Clinical trial NCT00763776: Parenchyma Resection of Cirrhotic Liver by the Clamp Crushing Technique and the Ultrasonic Dissector
Official title: Parenchyma Resection of Cirrhotic Liver by the Clamp Crushing Technique and the Ultrasonic Dissector : Randomized Comparative Study.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Liver Cirrhosis
Liver Neoplasms
Carcinoma, Hepatocellular
Keywords: Liver cirrhosis
Hepatectomy
Liver parenchyma transection
Randomized controlled trial
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2008-10-01
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intra-operative blood loss during liver transection (ml).
timeFrame: during liver transection
Secondary outcomes:
measure: Intra-operative blood loss standardized to the transection area (ml/cm²)
timeFrame: during liver transection
measure: free margins around the tumor
timeFrame: during liver transection
measure: postoperative liver ischemia-reperfusion injury (post-operative peak of transaminases)
timeFrame: daily until the discharge of the patient
measure: 60-day postoperative complications
timeFrame: 2 months after the liver transection
Other outcomes:
Locations:
city: Clichy
country: France
facility: Hôpital BEAUJON
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Mickael LESURTEL, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: