NCT02041065

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2011

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 20, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

September 1, 2015

Status Verified

August 1, 2015

Enrollment Period

4 years

First QC Date

October 9, 2013

Last Update Submit

August 31, 2015

Conditions

Liver Tumour

Keywords

Liver transectionBloodlossOperation timeSafetyfeasibility

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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)

Study Arms (2)

Waterjet induced dissection

EXPERIMENTAL

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

CUSA induced dissection

ACTIVE COMPARATOR

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

Interventions

Waterjet induced dissectionDEVICE

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.

Waterjet induced dissection
CUSA induced dissectionDEVICE

Ultrasound based destruction of the liver

CUSA induced dissection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hepatic tumour suitable for resection
  • patients 18 year or older Segmental resection Local resection Left sided hemihepatectomy

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital, Centra of Gastroenterology

Stockholm, 14186, Sweden

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Anders Jansson, MdPhd

    Karolinska University Hospital

    STUDY CHAIR

  • Lars Lundell, Professor

    Karolinska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 9, 2013

First Posted

January 20, 2014

Study Start

February 1, 2011

Primary Completion

February 1, 2015

Study Completion

March 1, 2015

Last Updated

September 1, 2015

Record last verified: 2015-08

Locations

SE(1)