Waterjet Versus Ultrasound Dissection During Hepatic Transection

Sponsor

Karolinska University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02041065

Collaborator

Bengt Isaksson (Other), Jansson, Anders, M.D. (Other)

Enrollment

Location

Arms

48.9

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Liver Tumour	Device: Waterjet induced dissection Device: CUSA induced dissection	Phase 2

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Waterjet Versus Ultrasound Dissection During Hepatic Transection

Study Start Date :

Feb 1, 2011

Actual Primary Completion Date :

Feb 1, 2015

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: 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.
Active Comparator: 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.	Device: CUSA induced dissection Ultrasound based destruction of the liver

Arm

Intervention/Treatment

Experimental: 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.

Device: 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.

Active Comparator: 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.

Device: CUSA induced dissection

Ultrasound based destruction of the liver

Outcome Measures

Primary Outcome Measures

Peroperative bloodloss [During liver transection (on an average<90 min)]
Peroperative bloodloss in ml during liver transection by use of either waterjet or CUSA.

Secondary Outcome Measures

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.