Waterjet Versus Ultrasound Dissection During Hepatic Transection

Phase 2

Completed

• Conditions: Liver Tumour
• Interventions: Device: Waterjet induced dissection; Device: CUSA induced dissection

• Registration Number: NCT02041065
• Lead Sponsor: Karolinska University Hospital

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2013-10-09
• Study First Submitted QC: 2014-01-17
• Study First Posted: 2014-01-20
• Primary Completion: 2015-02
• Study Completion: 2015-03
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-31
• Last Update Posted: 2015-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Waterjet induced dissection	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.
CUSA induced dissection	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Karolinska University Hospital, Centra of Gastroenterology; 🇸🇪 Stockholm, Sweden