Waterjet Versus Ultrasound Dissection During Hepatic Transection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2015-03-31

Brief Summary

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Before liver transection patients are allocated to either waterjet or CUSA to divide the liver parenchyma.

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Detailed Description

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

Conditions

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Liver Tumour

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Waterjet induced dissection

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.

Group Type EXPERIMENTAL

Waterjet induced dissection

Intervention Type DEVICE

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.

CUSA induced dissection

CUSA transection of the liver. Ultrasound based destruction of the liver parenchyma to allow separate ligation of the bile duct and intrahepatic vessels.

Group Type ACTIVE_COMPARATOR

CUSA induced dissection

Intervention Type DEVICE

Ultrasound based destruction of the liver

Interventions

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Waterjet induced dissection

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.

Intervention Type DEVICE

CUSA induced dissection

Ultrasound based destruction of the liver

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No