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

Assistance Publique - Hôpitaux de Paris

Status: Terminated

Conditions: Carcinoma, Hepatocellular; Liver Neoplasms; Liver Cirrhosis

Treatments: Device: clamp crushing technique; Device: ultrasonic dissector

Study type: Interventional

Funder types: Other

Identifiers

NCT00763776

K070105

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

1

Other group

Description:

Liver transection by clamp crushing technique

Treatment:

Device: clamp crushing technique

2

Other group

Description:

Liver transection by the ultrasonic dissector

Treatment:

Device: ultrasonic dissector