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Waterjet Versus Ultrasound Dissection During Hepatic Transection

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ClinicalTrials.gov Identifier: NCT02041065
Recruitment Status : Completed
First Posted : January 20, 2014
Last Update Posted : September 1, 2015
Sponsor:
Collaborators:
Bengt Isaksson
Jansson, Anders, M.D.
Information provided by (Responsible Party):
Lars Lundell, Karolinska University Hospital

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 Type : Interventional  (Clinical Trial)
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 : February 2011
Actual Primary Completion Date : February 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Transection time in minutes [ Time Frame: During liver transection (on an average< 90 minutes) ]
  2. Operation time in minutes [ Time Frame: Time spent in theater in minutes (on an average <240 minutes) ]
  3. Hospital stay in days [ Time Frame: Days spent in hospital after surgery (on an average < 10 days) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02041065


Locations
Sweden
Karolinska University Hospital, Centra of Gastroenterology
Stockholm, Sweden, 14186
Sponsors and Collaborators
Karolinska University Hospital
Bengt Isaksson
Jansson, Anders, M.D.
Investigators
Study Chair: Anders Jansson, MdPhd Karolinska University Hospital
Principal Investigator: Lars Lundell, Professor Karolinska University Hospital

Responsible Party: Lars Lundell, Professor, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT02041065     History of Changes
Other Study ID Numbers: 2011/2:4
2011/2.4 ( Other Identifier: Swedish Ethical Board )
First Posted: January 20, 2014    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: August 2015

Keywords provided by Lars Lundell, Karolinska University Hospital:
Liver transection
Bloodloss
Operation time
Safety
feasibility

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases