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

NCT ID: NCT00763776

Last Updated: 2014-02-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2010-09-30

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.

Conditions

Liver Cirrhosis; Liver Neoplasms; Carcinoma, Hepatocellular

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Liver transection by clamp crushing technique

Group Type: OTHER

clamp crushing technique

Intervention Type: DEVICE

Liver transection during hepatectomy by clamp crushing technique

2

Liver transection by the ultrasonic dissector

Group Type: OTHER

ultrasonic dissector

Intervention Type: DEVICE

Liver transection during hepatectomy by the ultrasonic dissector

Interventions

clamp crushing technique

Liver transection during hepatectomy by clamp crushing technique

Intervention Type: DEVICE

ultrasonic dissector

Liver transection during hepatectomy by the ultrasonic dissector

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mickael LESURTEL, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital BEAUJON

Clichy, , France

Countries

France

Other Identifiers

K070105

Identifier Type: -

Identifier Source: org_study_id