- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03323242
The Use of Technical Vessel Sealing Devices for Recipient Hepatectomy in Liver Transplantation (SEALIVE)
-SEALIVE- The Use of Technical Vessel Sealing Devices for Recipient Hepatectomy in Liver Transplantation: Study Protocol for a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Philipp Houben, MD
- Phone Number: +4962215636974
- Email: Philipp.Houben@med.uni-heidelberg.de
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- High urgency state of recipient
- Previous liver transplantation
- Combined organ transplantation
- Inability to give informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control group
Recipient hepatectomy using conventional bipolar coagulation devices, surgical suture ligatures, and surgical clips (or any dissecting / coagulating device other than LS)
|
|
Experimental: LS group
Recipient hepatectomy applying LigaSure.
|
The dissection of the small blood vessels and the connective tissue in the hepatoduodenal ligament is carried out with LigaSure
|
Experimental: USD group
Recipient hepatectomy applying Harmonic Ultrasonic dissector.
|
The dissection of the small blood vessels and the connective tissue in the hepatoduodenal ligament is carried out with Harmonic Ultrasonic dissector
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
One day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood loss during recipient hepatectomy
Time Frame: One day
|
One day
|
|
Time from skin incision to end of hemostasis after hepatectomy
Time Frame: One day
|
One day
|
|
Time from skin incision to end of skin closure
Time Frame: One day
|
One day
|
|
Hemodynamic status during surgery
Time Frame: One day
|
Data on the mean arterial pressure and central venous pressure will be obtained at the beginning of hepatectomy after incision and adhesiolysis.
|
One day
|
The number of packed red blood cells (PRBC) units transfused during surgery
Time Frame: One day
|
One day
|
|
The number of fresh frozen plasma (FFP) units transfused during surgery
Time Frame: One day
|
One day
|
|
The number of platelet units transfused during surgery
Time Frame: One day
|
One day
|
|
Conversion rate
Time Frame: One day
|
Conversion rate to alternative methods during recipient hepatectomy in LS and USD groups
|
One day
|
Coagulation state
Time Frame: Ten days
|
International Normalized Ratio, partial thromboplastin time and platelet levels of patients will be recorded pre- and postoperatively until POD 10.
|
Ten days
|
Hemoglobin level
Time Frame: Ten days
|
Hemoglobin Levels of patients will be recorded pre- and postoperatively until POD 10.
|
Ten days
|
Postoperative PRBC and FFP Transfusion until POD 10
Time Frame: Ten days
|
Ten days
|
|
Postoperative bleeding
Time Frame: Ten days
|
Postoperative hemorrhaging until POD 10 will be recorded and classified according to the Clavien-Dindo classification.
|
Ten days
|
Postoperative morbidity
Time Frame: Three months
|
Postoperative morbidity will be recorded and classified according to the Clavien-Dindo classification.
|
Three months
|
Retransplantation rate
Time Frame: Three months
|
Three months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Philipp Houben, MD, Department of General, Visceral and Transplant Surgery, University Hospital Heidelberg, Germany
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- S-217/2017
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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