The Use of Technical Vessel Sealing Devices for Recipient Hepatectomy in Liver Transplantation

NCT03323242 | Unknown

• 1 other identifier: S-217/2017
• Study Type: interventional
• Target: 69
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Hepatectomy

Keywords

Vessel Sealing Devices; Liver Transplantation

Outcome Measures

Primary Outcomes (1)

• 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.

  One day

Secondary Outcomes (14)

• Blood loss during recipient hepatectomy

  One day

• Time from skin incision to end of hemostasis after hepatectomy

  One day

• Time from skin incision to end of skin closure

  One day

• Hemodynamic status during surgery

  One day

• The number of packed red blood cells (PRBC) units transfused during surgery

  One day

Study Arms (3)

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.

Device: LigaSure

USD group

EXPERIMENTAL

Recipient hepatectomy applying Harmonic Ultrasonic dissector.

Device: Harmonic Ultrasonic dissector

Interventions

LigaSure DEVICE

The dissection of the small blood vessels and the connective tissue in the hepatoduodenal ligament is carried out with LigaSure

LS group

Harmonic Ultrasonic dissector DEVICE

The dissection of the small blood vessels and the connective tissue in the hepatoduodenal ligament is carried out with Harmonic Ultrasonic dissector

USD group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• High urgency state of recipient
• Previous liver transplantation
• Combined organ transplantation
• Inability to give informed consent

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Related Publications (1)

• 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.

  PMID: 30012178 DERIVED

Study Officials

• Philipp Houben, MD

  Department of General, Visceral and Transplant Surgery, University Hospital Heidelberg, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philipp Houben, MD

CONTACT

+4962215636974; Philipp.Houben@med.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding the surgical staff is impossible due to the use of different methods in the three groups under investigation. Since the primary endpoint "total blood loss" will be precisely recorded during surgery by independent staff and secondary endpoints are objective physiological findings, blinding the subjects is not needed. Therefore, the open design is not expected to cause any avoidable bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 7, 2017
• First Posted: October 26, 2017
• Study Start: August 1, 2018
• Primary Completion: July 1, 2021
• Study Completion: September 1, 2021
• Last Updated: July 13, 2018

Record last verified: 2018-07