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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00763776
Acronym
SECCI
Enrollment
27
Registered
2008-10-01
Start date
2008-07-31
Completion date
2010-09-30
Last updated
2014-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhosis, Liver Neoplasms, Carcinoma, Hepatocellular

Keywords

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

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.

Interventions

DEVICEclamp crushing technique

Liver transection during hepatectomy by clamp crushing technique

Liver transection during hepatectomy by the ultrasonic dissector

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
Intra-operative blood loss standardized to the transection area (ml/cm²)during liver transection
free margins around the tumorduring liver transection
postoperative liver ischemia-reperfusion injury (post-operative peak of transaminases)daily until the discharge of the patient
60-day postoperative complications2 months after the liver transection

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026