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

NCT00763776 | Terminated

• 1 other identifier: K070105
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis; Liver Neoplasms; Carcinoma, Hepatocellular

Keywords

Liver cirrhosis; Hepatectomy; Liver parenchyma transection; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Intra-operative blood loss during liver transection (ml).

  during liver transection

Secondary Outcomes (4)

• Intra-operative blood loss standardized to the transection area (ml/cm²)

  during liver transection

• free margins around the tumor

  during liver transection

• postoperative liver ischemia-reperfusion injury (post-operative peak of transaminases)

  daily until the discharge of the patient

• 60-day postoperative complications

  2 months after the liver transection

Study Arms (2)

1

OTHER

Liver transection by clamp crushing technique

Device: clamp crushing technique

2

OTHER

Liver transection by the ultrasonic dissector

Device: ultrasonic dissector

Interventions

clamp crushing technique DEVICE

Liver transection during hepatectomy by clamp crushing technique

1

ultrasonic dissector DEVICE

Liver transection during hepatectomy by the ultrasonic dissector

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital BEAUJON

Clichy, 92 118, France

Location

MeSH Terms

Conditions

Liver Cirrhosis; Liver Neoplasms; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Mickael LESURTEL, MD-PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2008
• First Posted: October 1, 2008
• Study Start: July 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: September 1, 2010
• Last Updated: February 27, 2014

Record last verified: 2011-01

Locations

FR (1)