Back to resultsWaterjet Versus Ultrasound Dissection During Hepatic Transection
Primary Purpose
Liver Tumour
Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Waterjet induced dissection
CUSA induced dissection
Sponsored by
About this trial
This is an interventional treatment trial for Liver Tumour focused on measuring Liver transection, Bloodloss, Operation time, Safety, feasibility
Eligibility 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.
Sites / Locations
- Karolinska University Hospital, Centra of Gastroenterology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Waterjet induced dissection
CUSA induced dissection
Arm Description
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 transection of the liver. Ultrasound based destruction of the liver parenchyma to allow separate ligation of the bile duct and intrahepatic vessels.
Outcomes
Primary Outcome Measures
Peroperative bloodloss
Peroperative bloodloss in ml during liver transection by use of either waterjet or CUSA.
Secondary Outcome Measures
Transection time in minutes
Operation time in minutes
Hospital stay in days
Full Information
NCT ID
NCT02041065
First Posted
October 9, 2013
Last Updated
August 31, 2015
Sponsor
Karolinska University Hospital
Collaborators
Bengt Isaksson, Jansson, Anders, M.D.
1. Study Identification
Unique Protocol Identification Number
NCT02041065
Brief Title
Waterjet Versus Ultrasound Dissection During Hepatic Transection
Official Title
Waterjet Versus Ultrasound Dissection During Hepatic Transection
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
Collaborators
Bengt Isaksson, Jansson, Anders, M.D.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Tumour
Keywords
Liver transection, Bloodloss, Operation time, Safety, feasibility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Waterjet induced dissection
Arm Type
Experimental
Arm Description
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.
Arm Title
CUSA induced dissection
Arm Type
Active Comparator
Arm Description
CUSA transection of the liver. Ultrasound based destruction of the liver parenchyma to allow separate ligation of the bile duct and intrahepatic vessels.
Intervention Type
Device
Intervention Name(s)
Waterjet induced dissection
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
CUSA induced dissection
Intervention Description
Ultrasound based destruction of the liver
Primary Outcome Measure Information:
Title
Peroperative bloodloss
Description
Peroperative bloodloss in ml during liver transection by use of either waterjet or CUSA.
Time Frame
During liver transection (on an average<90 min)
Secondary Outcome Measure Information:
Title
Transection time in minutes
Time Frame
During liver transection (on an average< 90 minutes)
Title
Operation time in minutes
Time Frame
Time spent in theater in minutes (on an average <240 minutes)
Title
Hospital stay in days
Time Frame
Days spent in hospital after surgery (on an average < 10 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Jansson, MdPhd
Organizational Affiliation
Karolinska University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lars Lundell, Professor
Organizational Affiliation
Karolinska University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital, Centra of Gastroenterology
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
12. IPD Sharing Statement
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Waterjet Versus Ultrasound Dissection During Hepatic Transection
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