Liver TumourPhase 2NCT02041065
Waterjet Versus Ultrasound Dissection During Hepatic Transection
A Phase 2 study testing Waterjet induced dissection and CUSA induced dissection in people with Liver Tumour, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
Before liver transection patients are allocated to either waterjet or CUSA to divide the liver parenchyma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Tumour
- What is being tested?
- Waterjet induced dissection and CUSA induced dissection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2011to Mar 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hepatic tumour suitable for resection
- patients 18 year or older Segmental resection Local resection Left sided hemihepatectomy
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska University Hospital, Centra of Gastroenterology
Stockholm, 14186
About this study
Before liver transection patients are allocated to either waterjet or CUSA to divide the liver parenchyma.
Read the detailed description
Transection time, bloodloss, total operation time and postoperative complication rates are registered.
- Conditions
- Liver Tumour
- Being tested
- Waterjet induced dissection, CUSA induced dissection
- Keywords
- Liver transection, Bloodloss, Operation time, Safety, feasibility
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
CUSA induced dissectionDevice
Ultrasound based destruction of the liver
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: CUSA induced dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peroperative bloodloss
Peroperative bloodloss in ml during liver transection by use of either waterjet or CUSA.
Measured: During liver transection (on an average<90 min)
Secondary outcomes (3)
Transection time in minutes
Measured: During liver transection (on an average< 90 minutes)
Operation time in minutes
Measured: Time spent in theater in minutes (on an average <240 minutes)
Hospital stay in days
Measured: Days spent in hospital after surgery (on an average < 10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startFeb 2011
- Primary completionFeb 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TumourStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bengt Isaksson, Jansson, Anders, M.D.
- Responsible party
- Principal investigator, Lars Lundell, Karolinska University Hospital
- Investigators
- Anders Jansson, MdPhd, Study chair, Karolinska University HospitalLars Lundell, Professor, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041065
- Sponsor's protocol ID
- 2011/2:4
- Other IDs
- 2011/2.4
- Status last verified
- Aug 2015
- First submitted
- 9 Oct 2013
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Waterjet Versus Ultrasound Dissection During Hepatic Transection
- ClinicalTrials.gov ID
- NCT02041065
- Acronym / sponsor ID
- 2011/2:4
- Conditions
- Liver Tumour
- Keywords
- Liver transection, Bloodloss, Operation time, Safety, feasibility
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Bengt Isaksson, Jansson, Anders, M.D.
- Study start
- Feb 2011
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 20 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Waterjet induced dissection | Experimental | Device: Waterjet induced dissectionWaterjet 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 | Active comparator | Device: CUSA induced dissectionCUSA transection of the liver. Ultrasound based destruction of the liver parenchyma to allow separate ligation of the bile duct and intrahepatic vessels. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hepatic tumour suitable for resection
- patients 18 year or older Segmental resection Local resection Left sided hemihepatectomy
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Waterjet induced dissectionWaterjet 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 dissectionUltrasound based destruction of the liver | Device | CUSA induced dissection |
Primary outcome
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.
3 secondary outcomes
Transection time in minutes
Time frame: 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)
Hospital stay in days
Time frame: Days spent in hospital after surgery (on an average < 10 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Jansson, MdPhd study chair
Karolinska University Hospital
Lars Lundell, Professor principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Waterjet induced dissection and CUSA induced dissection in people with Liver Tumour, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peroperative bloodloss (time frame: During liver transection (on an average<90 min)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2015.