Waterjet Versus Ultrasound Dissection During Hepatic Transection

August 31, 2015 updated by: Lars Lundell, Karolinska University Hospital
Before liver transection patients are allocated to either waterjet or CUSA to divide the liver parenchyma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 14186
        • Karolinska University Hospital, Centra of Gastroenterology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peroperative bloodloss
Time Frame: During liver transection (on an average<90 min)
Peroperative bloodloss in ml during liver transection by use of either waterjet or CUSA.
During liver transection (on an average<90 min)

Secondary Outcome Measures

Outcome Measure
Time Frame
Transection time in minutes
Time Frame: During liver transection (on an average< 90 minutes)
During liver transection (on an average< 90 minutes)
Operation time in minutes
Time Frame: Time spent in theater in minutes (on an average <240 minutes)
Time spent in theater in minutes (on an average <240 minutes)
Hospital stay in days
Time Frame: Days spent in hospital after surgery (on an average < 10 days)
Days spent in hospital after surgery (on an average < 10 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Collaborators

Bengt Isaksson
Jansson, Anders, M.D.

Investigators

  • Study Chair: Anders Jansson, MdPhd, Karolinska University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (ACTUAL)

February 1, 2015

Study Completion (ACTUAL)

March 1, 2015

Study Registration Dates

First Submitted

October 9, 2013

First Submitted That Met QC Criteria

January 17, 2014

First Posted (ESTIMATE)

January 20, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

September 1, 2015

Last Update Submitted That Met QC Criteria

August 31, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/2:4
  • 2011/2.4 (OTHER: Swedish Ethical Board)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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