Reduction of Peroperative Blood Loss During Liver ResectionPhase 2NCT02041078
Intra Versus Extrahepatic Division of Right Hepatic Vein During Rightsided Hemihepatectomy
A Phase 2 study testing Intrahepatic division of the right hepatic vein. and Extrahepatic vein division in people with Reduction of Peroperative Blood Loss During Liver Resection, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
Intrahepatic division of the hepatic vein is associated with less blood loss than extrahepatic dissection and division of the right hepatic vein. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Reduction of Peroperative Blood Loss During Liver Resection
- What is being tested?
- Intrahepatic division of the right hepatic vein. and Extrahepatic vein division
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- May 2011to Jul 2017
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hepatic lesion amenable to right sided hemihepatectomy.
Who cannot join
- Hepatic lesions not suitable for a anatomical right sided hemihepatectomy.
- Unfit for surgery
- Unwillingness to participate
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Surgery Gastrocentrum Karolinska Univeristy Hospital
Stockholm, 14186
About this study
Official title: Randomized Phase 2 Study of Intra Versus Extrahepatic Division of Right Hepatic Vein During Rightsided Hemihepatectomy
Intrahepatic division of the hepatic vein is associated with less blood loss than extrahepatic dissection and division of the right hepatic vein.
- Being tested
- Intrahepatic division of the right hepatic vein., Extrahepatic vein division
- Keywords
- Liver surgery, Blood loss, CUSA, Hepatic transection
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrahepatic division of the right hepatic vein.Procedure or surgery
Ligation and division of the entrance of the right hepatic vein into the suprarenal cava vein are done at the end of transection of the liver parenchyma with CUSA.
Extrahepatic vein divisionProcedure or surgery
Standard surgical procedure with extrahepatic ligation/division of the right hepatic vein prior to parenchymal division with CUSA.
| Study group | Role | What they receive |
|---|---|---|
| Extrahepatic vein division | Placebo comparator | Conventional right sided hemihepatectomy with division of the liver parenchyma with CUSA. Receives: Procedure: Extrahepatic vein division |
| Intrahepatic vein division | Experimental | Conventional right sided hemihepatectomy with division of the liver parenchyma with CUSA and intrahepatic division of the right hepatic vein. Receives: Procedure: Intrahepatic division of the right hepatic vein. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative bloodloss
Measured: Intraoperative time (in minutes) for the division of the liver parenchyma
Secondary outcomes (2)
Operation time, postoperative complication rate
Measured: Total time in minutes spent in theater, in hospital stay in days (on an average less than 30 days), total complication rate during hospital stay (on an average less than 30 days), surgical complications during in hospital stay (on an average<30days).
postoperative complication rate
Measured: in hospital stay in days (on an average <30 days), total complication rate during hospital stay (on an average <30 days), surgical complications during in hospital stay (on an average <30 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 startMay 2011
- Primary completionJun 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reduction of Peroperative Blood Loss During Liver ResectionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jansson, Anders, M.D., Bengt Isaksson
- Responsible party
- Principal investigator, Lars Lundell, Karolinska University Hospital
- Investigators
- Lars Lundell, Professor, Principal investigator, Gastrocentrum Karolinska University Hospital Huddinge, 141 86 Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041078
- Sponsor's protocol ID
- 2011/563-31/2
- Other IDs
- 2011/563-31/2
- Status last verified
- Feb 2017
- First submitted
- 9 Oct 2013
- Last updated
- 20 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase 2 Study of Intra Versus Extrahepatic Division of Right Hepatic Vein During Rightsided Hemihepatectomy
- ClinicalTrials.gov ID
- NCT02041078
- Acronym / sponsor ID
- 2011/563-31/2
- Keywords
- Liver surgery, Blood loss, CUSA, Hepatic transection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Jansson, Anders, M.D., Bengt Isaksson
- Study start
- May 2011
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- 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.
Intrahepatic division of the hepatic vein is associated with less blood loss than extrahepatic dissection and division of the right hepatic vein.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extrahepatic vein division | Placebo comparator | Procedure: Extrahepatic vein divisionConventional right sided hemihepatectomy with division of the liver parenchyma with CUSA. |
| Intrahepatic vein division | Experimental | Procedure: Intrahepatic division of the right hepatic vein.Conventional right sided hemihepatectomy with division of the liver parenchyma with CUSA and intrahepatic division of the right hepatic vein. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hepatic lesion amenable to right sided hemihepatectomy.
Key exclusion criteria (3 listed)
- Hepatic lesions not suitable for a anatomical right sided hemihepatectomy.
- Unfit for surgery
- Unwillingness to participate
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 |
|---|---|---|
| Intrahepatic division of the right hepatic vein.Ligation and division of the entrance of the right hepatic vein into the suprarenal cava vein are done at the end of transection of the liver parenchyma with CUSA. | Procedure or surgery | Intrahepatic vein division |
| Extrahepatic vein divisionStandard surgical procedure with extrahepatic ligation/division of the right hepatic vein prior to parenchymal division with CUSA. | Procedure or surgery | Extrahepatic vein division |
Primary outcome
Intraoperative bloodloss
Time frame: Intraoperative time (in minutes) for the division of the liver parenchyma
2 secondary outcomes
Operation time, postoperative complication rate
Time frame: Total time in minutes spent in theater, in hospital stay in days (on an average less than 30 days), total complication rate during hospital stay (on an average less than 30 days), surgical complications during in hospital stay (on an average<30days).
postoperative complication rate
Time frame: in hospital stay in days (on an average <30 days), total complication rate during hospital stay (on an average <30 days), surgical complications during in hospital stay (on an average <30 days).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2017.
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.
Lars Lundell, Professor principal investigator
Gastrocentrum Karolinska University Hospital Huddinge, 141 86 Stockholm
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 Intrahepatic division of the right hepatic vein. and Extrahepatic vein division in people with Reduction of Peroperative Blood Loss During Liver Resection, 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 Feb 2017. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Intraoperative bloodloss (time frame: Intraoperative time (in minutes) for the division of the liver parenchyma). 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 20 Feb 2017.