Waterjet Versus Ultrasound Dissection During Hepatic Transection

Study Overview
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Brief Summary
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Before liver transection patients are allocated to either waterjet or CUSA to divide the liver parenchyma.

Detailed Description
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Transection time, bloodloss, total operation time and postoperative complication rates are registered.

Official Title
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Waterjet Versus Ultrasound Dissection During Hepatic Transection

Conditions
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Liver Tumour

Intervention / Treatment
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* Device: Waterjet induced dissection
* Device: CUSA induced dissection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hepatic tumour suitable for resection patients 18 year or older Segmental resection Local resection Left sided hemihepatectomy Exclusion Criteria: Right sided hemihepatectoyReresection In Situ Split Liver Extended left- and rightsided hemihepatectomy Lobus caudatus resection Central resections Hilus tumour/Klatskin/Cholangiocarcinoma Surgery on biliary tree Extended resection on other organs Resection on gallbladder Resection on other organs during the same operation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Waterjet induced dissection<br>Waterjet induced dissection of the liver during resection.Waterjet dissection device mechanically separates hepatic tissue from bile ducts and vessels, the latter two to be separately ligated. | Device: Waterjet induced dissection<br>* Waterjet induced dissection of the liver during resection.Waterjet dissection device mechanically separates hepatic tissue from bile ducts and vessels, the latter two to be separately ligated.<br>|
| Active Comparator: CUSA induced dissection<br>CUSA transection of the liver. Ultrasound based destruction of the liver parenchyma to allow separate ligation of the bile duct and intrahepatic vessels. | Device: CUSA induced dissection<br>* Ultrasound based destruction of the liver<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peroperative bloodloss | Peroperative bloodloss in ml during liver transection by use of either waterjet or CUSA. | During liver transection (on an average<90 min) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transection time in minutes |  | During liver transection (on an average< 90 minutes) | 
| Operation time in minutes |  | Time spent in theater in minutes (on an average <240 minutes) | 
| Hospital stay in days |  | Days spent in hospital after surgery (on an average < 10 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver transection, Bloodloss, Operation time, Safety, feasibility