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

Liver Cirrhosis Clinical Trial

— SECCI  

Official title:

Parenchyma Resection of Cirrhotic Liver by the Clamp Crushing Technique and the Ultrasonic Dissector : Randomized Comparative Study.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00763776
• Other study ID #: K070105
• Status: Terminated
• Phase: N/A
• First received: September 30, 2008
• Last updated: February 26, 2014
• Start date: July 2008
• Est. completion date: September 2010

Study information

• Verified date: January 2011
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Data Protection Authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: September 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Cirrhosis
• Liver Neoplasms

Intervention

Device:
• clamp crushing technique
Liver transection during hepatectomy by clamp crushing technique
• ultrasonic dissector
Liver transection during hepatectomy by the ultrasonic dissector

Locations

Country	Name	City	State
France	Hôpital BEAUJON	Clichy

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra-operative blood loss during liver transection (ml).		during liver transection	Yes
Secondary	Intra-operative blood loss standardized to the transection area (ml/cm²)		during liver transection	Yes
Secondary	free margins around the tumor		during liver transection	Yes
Secondary	postoperative liver ischemia-reperfusion injury (post-operative peak of transaminases)		daily until the discharge of the patient	Yes
Secondary	60-day postoperative complications		2 months after the liver transection	Yes