Parenchyma Resection of Cirrhotic Liver by the Clamp Crushing Technique and the Ultrasonic Dissector - Full Text View

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00763776

Purpose

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.

Condition	Intervention
Liver Cirrhosis Liver Neoplasms Carcinoma, Hepatocellular	Device: clamp crushing technique Device: ultrasonic dissector

MedlinePlus related topics: Cancer Cirrhosis Liver Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Parenchyma Resection of Cirrhotic Liver by the Clamp Crushing Technique and the Ultrasonic Dissector : Randomized Comparative Study.

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Intra-operative blood loss during liver transection (ml). [ Time Frame: during liver transection ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Intra-operative blood loss standardized to the transection area (ml/cm²) [ Time Frame: during liver transection ] [ Designated as safety issue: Yes ]
free margins around the tumor [ Time Frame: during liver transection ] [ Designated as safety issue: Yes ]
postoperative liver ischemia-reperfusion injury (post-operative peak of transaminases) [ Time Frame: daily until the discharge of the patient ] [ Designated as safety issue: Yes ]
60-day postoperative complications [ Time Frame: 2 months after the liver transection ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	July 2008
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Liver transection by clamp crushing technique	Device: clamp crushing technique Liver transection during hepatectomy by clamp crushing technique
2 Liver transection by the ultrasonic dissector	Device: ultrasonic dissector Liver transection during hepatectomy by the ultrasonic dissector

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00763776

Contacts

Contact: Mickael LESURTEL, MD, PhD

33 (0)1 40 87 58 95

mickael.lesurtel@bjn.aphp.fr

Locations

France
Hôpital BEAUJON	Recruiting
Clichy, France, 92 118
Contact: Mickael LESURTEL, MD, PhD 33 (0)1 40 87 58 95 mickael.lesurtel@bjn.aphp.fr
Principal Investigator: Mickael LESURTEL, MD, PhD

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Mickael LESURTEL, MD-PhD

Assistance Publique - Hôpitaux de Paris

More Information

Responsible Party:	Department Clinical Research of Developpement ( Cecile Jourdain )
Study ID Numbers:	K070105, N° IDRBC 2007-A01241-52
Study First Received:	September 30, 2008
Last Updated:	September 30, 2008
ClinicalTrials.gov Identifier:	NCT00763776
Health Authority:	France: French Data Protection Authority

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Liver cirrhosis
Hepatectomy
Liver parenchyma transection
Randomized controlled trial

Study placed in the following topic categories:

Liver Neoplasms
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Fibrosis
Carcinoma, Hepatocellular

Liver neoplasms
Gastrointestinal Neoplasms
Liver Cirrhosis
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Pathologic Processes
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 14, 2009