HepatectomySEALIVENCT03323242
The Use of Technical Vessel Sealing Devices for Recipient Hepatectomy in Liver Transplantation
A study testing LigaSure and Harmonic Ultrasonic dissector in people with Hepatectomy, run by University Hospital Heidelberg.
Trial summary
The surgical technique used in liver transplantation has undergone constant Evolution in an effort towards towards a safe, highly standardized procedure. Despite this, the initial step of the recipients' hepatectomy has not been in the focus of clinical research thus far. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatectomy
- What is being tested?
- LigaSure and Harmonic Ultrasonic dissector
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2018to 1 Sep 2021
- Phase
- Interventional
- 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
- Allocation of donor liver via Eurotransplant to recipient
- Recipients must be aged 18 or older
- A signed, written informed consent for participation in the trial
Who cannot join
- High urgency state of recipient
- Previous liver transplantation
- Combined organ transplantation
- Inability to give informed consent
Trial locations and contacts
No sites are listed yet.
About this study
Official title: -SEALIVE- The Use of Technical Vessel Sealing Devices for Recipient Hepatectomy in Liver Transplantation: Study Protocol for a Randomized Controlled Trial
The surgical technique used in liver transplantation has undergone constant Evolution in an effort towards towards a safe, highly standardized procedure. Despite this, the initial step of the recipients' hepatectomy has not been in the focus of clinical research thus far. Due to usually advanced coagulopathy in liver transplantation recipients, this part of the operation still bares the risk of severe hemorrhage. This trial is designed to compare an electrothermic, bipolar vessel sealing device (LigaSureTM) and an ultrasound dissector (HARMONIC ACE®+7) to standard surgical techniques during the recipients' hepatectomy in liver transplantation. In a single center, prospective, randomized, controlled, parallel three armed, confirmatory, open trial, LigaSureTM and HARMONIC ACE®+7 will be compared to standard surgical techniques which, utilize titanium clips and conventional knot tying ligations during the recipients' hepatectomy in liver transplantation. Intraoperative total blood loss is the primary endpoint of the trial. Secondary endpoints include blood loss during the hepatectomy, the duration of both the hepatectomy and the entire surgical procedure, as well as blood transfusion requirements of the procedure. To generate reliable data, intraoperative blood loss will be recorded with respect to all rinse fluids during surgery, ascites and by weighing used swabs to generate reliable data. At 80% power and an alpha of 0.025 for both either of the experimental groups, twenty-three subjects will be analysed per protocol in each study arm in order to detect a clinically relevant reduction of intraoperative blood loss. The intention to treat analysis will include sixty-nine patients. The follow up period for each patient will be 90 days for safety reasons, whereas all clinical outcomes will be measured within the first ten postoperative days. This is the first prospective, randomized trial comparing two innovative, technical methods of vessel sealing and dissection against standard techniques for recipient hepatectomy. This will be done to detect a relevant reduction of intraoperative blood loss during liver transplantation.The results of the trial are expected to improve patients' outcome and safety after liver transplantation and to increase the general safety of this procedure.
Read the detailed description
Liver transplantation (LT) is a well-established procedure for the treatment of end stage liver disease. Many improvements in the surgical technique rendered this operation relatively safe. Most important operative innovations after the initial introduction of LT in the clinical Routine undertaken by Starzl include the use of veno-venous bypass in LT, the piggy-back technique with preservation of the recipients' caval vein and it's modification which was introduced by Belghiti with side-to-side cavo-caval anastomosis. Nevertheless very few improvements have been introduced in the surgical technique with regards to tissue preparation and sealing the blood vessels during recipient hepatectomy. Due to end stage liver disease and both the recipients' general and coagulatory condition, the hepatectomy carries the risk of severe blood loss which can impair the outcome after LT. Usually the recipient hepatectomy is carried out as a combination of sharp dissection of the hepatic adhesions to the abdominal wall and the diaphragm and clip or suture ligature of small retrohepatic caval vein branches.
With advances in surgical procedures and equipment, modern technologies have been introduced, which have shortened operation time and improved surgical outcomes. Exquisite equipment for liver parenchyma transection, such as Cavitron ultrasonic surgical aspirator, ultrasonic dissector (USD), LigaSure (LS) and Tissue Link can also be used to reduce hemorrhage in liver resection. The ultrasonic scalpel (Ethicon) is a new USD that cuts and coagulates tissue using ultrasound at frequencies higher than those used by an ultrasonic aspirator. This device can also serve as a grasper and basically utilizes a blade which oscillates at 55 kHz, thus producing heat and enabling coagulation of vessels. Recently, its use and potential advantages in open liver resection have been demonstrated. The main technical advancement in this field relates to decreased intra-operative bleeding. Results of using USD (Harmonic Scalpel) during recipient hepatectomy showed that this method is safe compared with conventional knot tying ligation regarding intra- and postoperative bleeding rate. The electrothermal bipolar vessel sealing device LS is another alternative, which applies electrothermal bipolar coagulation and dissection in one step. The LS dissection device seals the tissue first before it is divided (both Tasks are performed with the same device). This may prevent severe bleeding. Furthermore, the sealing device is capable of coping with the small liver veins which can be sealed and divided safely without the need for sutures or clips. Especially the latter of which is known for interfering with sufficient "tangential" clamping of the inferior caval vein (IVC) for side to side cavo-cavostomy during piggy-back LT. It was reported that the use of LS devices for recipient hepatectomy in LT. It was concluded that, LS vessel sealing was an efficient method and that vessel sealing of the caval and Portal veins as well as other structures could be safely performed in the setting of end-stage liver disease.
To our knowledge, no randomized clinical trial has been conducted to compare various innovative dissection methods against the standard techniques used for recipient hepatectomy. While LS and USD have been proven to be used safely in several major surgical procedures, including liver resection, their ability to reduce blood loss in liver transplant recipient hepatectomy has not yet been evaluated systematically.
- Conditions
- Hepatectomy
- Being tested
- LigaSure, Harmonic Ultrasonic dissector
- Keywords
- Vessel Sealing Devices, Liver Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LigaSureDevice
The dissection of the small blood vessels and the connective tissue in the hepatoduodenal ligament is carried out with LigaSure
Harmonic Ultrasonic dissectorDevice
The dissection of the small blood vessels and the connective tissue in the hepatoduodenal ligament is carried out with Harmonic Ultrasonic dissector
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Recipient hepatectomy using conventional bipolar coagulation devices, surgical suture ligatures, and surgical clips (or any dissecting / coagulating device other than LS) |
| LS group | Experimental | Recipient hepatectomy applying LigaSure. Receives: Device: LigaSure |
| USD group | Experimental | Recipient hepatectomy applying Harmonic Ultrasonic dissector. Receives: Device: Harmonic Ultrasonic dissector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Blood loss during surgical procedure
The suction container fluid volume (in 20 milliliters) will be added to the weight (in grams) of all surgical swabs at the end of skin closure procedures (A). The difference of the density of the rinse solution (isotonic Sodium Chloride solution) and blood is approximately 0.055 g/cm³. Regarding the accuracy of these measurements, this difference is clinically irrelevant.
The volume of the entire rinse fluid (in milliliters) that is used during the procedure and the amount of ascites (in milliliters) will be added to the known dry weight (in grams) of the respective number of surgical swabs that are used during the procedure and the known dry weight of the drip catching swab container (B).
The total blood loss is defined as "A" minus "B" in milliliters.
Measured: One day
Secondary outcomes (14)
Blood loss during recipient hepatectomy
Measured: One day
Time from skin incision to end of hemostasis after hepatectomy
Measured: One day
Time from skin incision to end of skin closure
Measured: One day
Hemodynamic status during surgery
Data on the mean arterial pressure and central venous pressure will be obtained at the beginning of hepatectomy after incision and adhesiolysis.
Measured: One day
The number of packed red blood cells (PRBC) units transfused during surgery
Measured: One day
The number of fresh frozen plasma (FFP) units transfused during surgery
Measured: One day
The number of platelet units transfused during surgery
Measured: One day
Conversion rate
Conversion rate to alternative methods during recipient hepatectomy in LS and USD groups
Measured: One day
Coagulation state
International Normalized Ratio, partial thromboplastin time and platelet levels of patients will be recorded pre- and postoperatively until POD 10.
Measured: Ten days
Hemoglobin level
Hemoglobin Levels of patients will be recorded pre- and postoperatively until POD 10.
Measured: Ten days
Postoperative PRBC and FFP Transfusion until POD 10
Measured: Ten days
Postoperative bleeding
Postoperative hemorrhaging until POD 10 will be recorded and classified according to the Clavien-Dindo classification.
Measured: Ten days
Postoperative morbidity
Postoperative morbidity will be recorded and classified according to the Clavien-Dindo classification.
Measured: Three months
Retransplantation rate
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start1 Aug 2018 (estimated)
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HepatectomyStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. A. Mehrabi, University Hospital Heidelberg
- Investigators
- Philipp Houben, MD, Principal investigator, Department of General, Visceral and Transplant Surgery, University Hospital Heidelberg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323242
- Sponsor's protocol ID
- S-217/2017
- Acronym
- SEALIVE
- Status last verified
- Jul 2018
- First submitted
- 7 Sep 2017
- Last updated
- 13 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Houben P, Khajeh E, Hinz U, Knebel P, Diener MK, Mehrabi A. SEALIVE: the use of technical vessel-sealing devices for recipient hepatectomy in liver transplantation: study protocol for a randomized controlled trial. Trials. 2018 Jul 16;19(1):380. doi: 10.1186/s13063-018-2778-1.
PubMed 30012178
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- -SEALIVE- The Use of Technical Vessel Sealing Devices for Recipient Hepatectomy in Liver Transplantation: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03323242
- Acronym / sponsor ID
- SEALIVE / S-217/2017
- Conditions
- Hepatectomy
- Keywords
- Vessel Sealing Devices, Liver Transplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- 1 Aug 2018 (estimated)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 26 Oct 2017 (actual)
- 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.
The surgical technique used in liver transplantation has undergone constant Evolution in an effort towards towards a safe, highly standardized procedure. Despite this, the initial step of the recipients' hepatectomy has not been in the focus of clinical research thus far. Due to usually advanced coagulopathy in liver transplantation recipients, this part of the operation still bares the risk of severe hemorrhage. This trial is designed to compare an electrothermic, bipolar vessel sealing device (LigaSureTM) and an ultrasound dissector (HARMONIC ACE®+7) to standard surgical techniques during the recipients' hepatectomy in liver transplantation. In a single center, prospective, randomized, controlled, parallel three armed, confirmatory, open trial, LigaSureTM and HARMONIC ACE®+7 will be compared to standard surgical techniques which, utilize titanium clips and conventional knot tying ligations during the recipients' hepatectomy in liver transplantation. Intraoperative total blood loss is the primary endpoint of the trial. Secondary endpoints include blood loss during the hepatectomy, the duration of both the hepatectomy and the entire surgical procedure, as well as blood transfusion requirements of the procedure. To generate reliable data, intraoperative blood loss will be recorded with respect to all rinse fluids during surgery, ascites and by weighing used swabs to generate reliable data. At 80% power and an alpha of 0.025 for both either of the experimental groups, twenty-three subjects will be analysed per protocol in each study arm in order to detect a clinically relevant reduction of intraoperative blood loss. The intention to treat analysis will include sixty-nine patients. The follow up period for each patient will be 90 days for safety reasons, whereas all clinical outcomes will be measured within the first ten postoperative days. This is the first prospective, randomized trial comparing two innovative, technical methods of vessel sealing and dissection against standard techniques for recipient hepatectomy. This will be done to detect a relevant reduction of intraoperative blood loss during liver transplantation.The results of the trial are expected to improve patients' outcome and safety after liver transplantation and to increase the general safety of this procedure.
Detailed description
Liver transplantation (LT) is a well-established procedure for the treatment of end stage liver disease. Many improvements in the surgical technique rendered this operation relatively safe. Most important operative innovations after the initial introduction of LT in the clinical Routine undertaken by Starzl include the use of veno-venous bypass in LT, the piggy-back technique with preservation of the recipients' caval vein and it's modification which was introduced by Belghiti with side-to-side cavo-caval anastomosis. Nevertheless very few improvements have been introduced in the surgical technique with regards to tissue preparation and sealing the blood vessels during recipient hepatectomy. Due to end stage liver disease and both the recipients' general and coagulatory condition, the hepatectomy carries the risk of severe blood loss which can impair the outcome after LT. Usually the recipient hepatectomy is carried out as a combination of sharp dissection of the hepatic adhesions to the abdominal wall and the diaphragm and clip or suture ligature of small retrohepatic caval vein branches.
With advances in surgical procedures and equipment, modern technologies have been introduced, which have shortened operation time and improved surgical outcomes. Exquisite equipment for liver parenchyma transection, such as Cavitron ultrasonic surgical aspirator, ultrasonic dissector (USD), LigaSure (LS) and Tissue Link can also be used to reduce hemorrhage in liver resection. The ultrasonic scalpel (Ethicon) is a new USD that cuts and coagulates tissue using ultrasound at frequencies higher than those used by an ultrasonic aspirator. This device can also serve as a grasper and basically utilizes a blade which oscillates at 55 kHz, thus producing heat and enabling coagulation of vessels. Recently, its use and potential advantages in open liver resection have been demonstrated. The main technical advancement in this field relates to decreased intra-operative bleeding. Results of using USD (Harmonic Scalpel) during recipient hepatectomy showed that this method is safe compared with conventional knot tying ligation regarding intra- and postoperative bleeding rate. The electrothermal bipolar vessel sealing device LS is another alternative, which applies electrothermal bipolar coagulation and dissection in one step. The LS dissection device seals the tissue first before it is divided (both Tasks are performed with the same device). This may prevent severe bleeding. Furthermore, the sealing device is capable of coping with the small liver veins which can be sealed and divided safely without the need for sutures or clips. Especially the latter of which is known for interfering with sufficient "tangential" clamping of the inferior caval vein (IVC) for side to side cavo-cavostomy during piggy-back LT. It was reported that the use of LS devices for recipient hepatectomy in LT. It was concluded that, LS vessel sealing was an efficient method and that vessel sealing of the caval and Portal veins as well as other structures could be safely performed in the setting of end-stage liver disease.
To our knowledge, no randomized clinical trial has been conducted to compare various innovative dissection methods against the standard techniques used for recipient hepatectomy. While LS and USD have been proven to be used safely in several major surgical procedures, including liver resection, their ability to reduce blood loss in liver transplant recipient hepatectomy has not yet been evaluated systematically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Recipient hepatectomy using conventional bipolar coagulation devices, surgical suture ligatures, and surgical clips (or any dissecting / coagulating device other than LS) |
| LS group | Experimental | Device: LigaSureRecipient hepatectomy applying LigaSure. |
| USD group | Experimental | Device: Harmonic Ultrasonic dissectorRecipient hepatectomy applying Harmonic Ultrasonic dissector. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Allocation of donor liver via Eurotransplant to recipient
- Recipients must be aged 18 or older
- A signed, written informed consent for participation in the trial
Key exclusion criteria (4 listed)
- High urgency state of recipient
- Previous liver transplantation
- Combined organ transplantation
- Inability to give informed consent
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 |
|---|---|---|
| LigaSureThe dissection of the small blood vessels and the connective tissue in the hepatoduodenal ligament is carried out with LigaSure | Device | LS group |
| Harmonic Ultrasonic dissectorThe dissection of the small blood vessels and the connective tissue in the hepatoduodenal ligament is carried out with Harmonic Ultrasonic dissector | Device | USD group |
Primary outcome
Total Blood loss during surgical procedure
Time frame: One day
The suction container fluid volume (in 20 milliliters) will be added to the weight (in grams) of all surgical swabs at the end of skin closure procedures (A). The difference of the density of the rinse solution (isotonic Sodium Chloride solution) and blood is approximately 0.055 g/cm³. Regarding the accuracy of these measurements, this difference is clinically irrelevant. The volume of the entire rinse fluid (in milliliters) that is used during the procedure and the amount of ascites (in milliliters) will be added to the known dry weight (in grams) of the respective number of surgical swabs that are used during the procedure and the known dry weight of the drip catching swab container (B). The total blood loss is defined as "A" minus "B" in milliliters.
14 secondary outcomes
Blood loss during recipient hepatectomy
Time frame: One day
Time from skin incision to end of hemostasis after hepatectomy
Time frame: One day
Time from skin incision to end of skin closure
Time frame: One day
Hemodynamic status during surgery
Time frame: One day
The number of packed red blood cells (PRBC) units transfused during surgery
Time frame: One day
The number of fresh frozen plasma (FFP) units transfused during surgery
Time frame: One day
The number of platelet units transfused during surgery
Time frame: One day
Conversion rate
Time frame: One day
Coagulation state
Time frame: Ten days
Hemoglobin level
Time frame: Ten days
Postoperative PRBC and FFP Transfusion until POD 10
Time frame: Ten days
Postoperative bleeding
Time frame: Ten days
Postoperative morbidity
Time frame: Three months
Retransplantation rate
Time frame: Three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2018.
- Derived from this study: PubMed 30012178Houben P, Khajeh E, Hinz U, Knebel P, Diener MK, Mehrabi A. SEALIVE: the use of technical vessel-sealing devices for recipient hepatectomy in liver transplantation: study protocol for a randomized controlled trial. Trials. 2018 Jul 16;19(1):380. doi: 10.1186/s13063-018-2778-1.
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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.
Philipp Houben, MD principal investigator
Department of General, Visceral and Transplant Surgery, University Hospital Heidelberg, Germany
Questions about this trial
What is this clinical trial studying?
A study testing LigaSure and Harmonic Ultrasonic dissector in people with Hepatectomy, run by University Hospital Heidelberg.
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 3 inclusion and 4 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 13 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Contact Philipp Houben, MD (+4962215636974, Philipp.Houben@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Blood loss during surgical procedure (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03323242, which also lists 1 linked publication.
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 13 Jul 2018.