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

Not Applicable

Terminated

• Conditions: Liver Cirrhosis; Liver Neoplasms; Carcinoma, Hepatocellular
• Interventions: Device: clamp crushing technique; Device: ultrasonic dissector

• Registration Number: NCT00763776
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-09-30
• Study First Submitted QC: 2008-09-30
• Study First Posted: 2008-10-01
• Primary Completion: 2010-08
• Study Completion: 2010-09
• Status Verified: 2011-01
• Last Update Submitted: 2014-02-26
• Last Update Posted: 2014-02-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Child A liver cirrhosis
• Partial hepatectomy (≥ 1 segment).
• Patient at least 18 years of age

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Exclusion Criteria

• Non cirrhotic patient
• Child B or C cirrhosis
• Portal hypertension
• Laparoscopic hepatectomy.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	clamp crushing technique	Liver transection by clamp crushing technique
2	ultrasonic dissector	Liver transection by the ultrasonic dissector

Primary Outcome Measures

Name	Time	Method
Intra-operative blood loss during liver transection (ml).	during liver transection

Secondary Outcome Measures

Name	Time	Method
Intra-operative blood loss standardized to the transection area (ml/cm²)	during liver transection
postoperative liver ischemia-reperfusion injury (post-operative peak of transaminases)	daily until the discharge of the patient
free margins around the tumor	during liver transection
60-day postoperative complications	2 months after the liver transection

Trial Locations

Locations (1)

Hôpital BEAUJON; 🇫🇷 Clichy, France