Waterjet Versus Ultrasound Dissection During Hepatic Transection

Liver Tumour Clinical Trial

Official title:

Waterjet Versus Ultrasound Dissection During Hepatic Transection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02041065
• Other study ID #: 2011/2:4
• Secondary ID: 2011/2.4
• Status: Completed
• Phase: Phase 2
• First received: October 9, 2013
• Last updated: August 31, 2015
• Start date: February 2011
• Est. completion date: March 2015

Study information

• Verified date: August 2015
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: March 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Tumour

Intervention

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.
• CUSA induced dissection
Ultrasound based destruction of the liver

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital, Centra of Gastroenterology	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
Karolinska University Hospital	Bengt Isaksson, Jansson, Anders, M.D.

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peroperative bloodloss	Peroperative bloodloss in ml during liver transection by use of either waterjet or CUSA.	During liver transection (on an average<90 min)	Yes
Secondary	Transection time in minutes		During liver transection (on an average< 90 minutes)	Yes
Secondary	Operation time in minutes		Time spent in theater in minutes (on an average <240 minutes)	Yes
Secondary	Hospital stay in days		Days spent in hospital after surgery (on an average < 10 days)	Yes