SEALIVE: the use of technical vessel-sealing devices for recipient hepatectomy in liver transplantation: study protocol for a randomized controlled trial

Philipp Houben, Elias Khajeh, Ulf Hinz, Phillip Knebel, Markus K Diener, Arianeb Mehrabi, Philipp Houben, Elias Khajeh, Ulf Hinz, Phillip Knebel, Markus K Diener, Arianeb Mehrabi

Abstract

Background: The surgical technique used in liver transplantation has undergone constant evolution in an effort to develop a safe, highly standardized procedure. Despite this, the initial step of recipient hepatectomy has not been the focus of clinical research thus far. Due to advanced coagulopathy in liver transplant recipients, this part of the operation still carries the risk of severe hemorrhage. This trial is designed to compare an electrothermal bipolar vessel sealing device (LigaSure™) and an ultrasound dissector (HARMONIC ACE®+7) with standard surgical techniques during the recipients' hepatectomy in liver transplantation.

Methods/design: In a single-center, prospective, randomized, controlled, parallel, three-armed, confirmatory, open trial, LigaSure™ and HARMONIC ACE®+7 will be compared with standard surgical techniques that use titanium clips and conventional knot-tying ligations during recipient hepatectomy in liver transplantation. Intraoperative total blood loss is the primary endpoint of the trial. Secondary endpoints include blood loss during hepatectomy, the duration of both the hepatectomy and the entire surgical procedure, and 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. At 80% power and an alpha of 0.025 for both of the experimental groups, 23 subjects will be analyzed per protocol in each study arm in order to detect clinically relevant reduction of intraoperative blood loss. The intention-to-treat analysis will include 69 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 10 postoperative days.

Discussion: To our knowledge, this is the first prospective, randomized trial comparing two innovative technical methods of vessel sealing and dissection with standard techniques for recipient hepatectomy. This will be done to detect relevant reduction of intraoperative blood loss during liver transplant. The results of the trial are expected to improve patient outcome and safety after liver transplant and to increase the general safety of this procedure.

Trial registration: ClinicalTrials.gov, NCT 03323242 . Registered on October 26, 2017.

Trial registration: ClinicalTrials.gov NCT03323242.

Keywords: Liver transplantation; Recipient hepatectomy; Surgical technique.

Conflict of interest statement

Ethics approval and consent to participate

The trial will be carried out in accordance with the 2013 version of the Helsinki declaration. The clinical trial will be conducted in accordance with the European Union’s recommendations on good clinical practice. The trial protocol design is in accordance with the recommendations of the Consolidated Standards of Reporting Trials (CONSORT) and Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines [33, 34]. Prior to the start of the trial, the study protocol was submitted to the ethics review committee of the medical faculty of the University of Heidelberg for consultation. The respective approval (S-217/2017) was received on May 25, 2017. An approval of protocol changes was received on March 29, 2018. All relevant changes in the protocol will be announced to the ethics review committee. Participation in the trial is voluntary and is not associated with financial rewards or any other implied benefits for the patient. Patients can withdraw their consent to participate in the trial at any time without stating the reasons for withdrawal or being subject to any adverse consequences over the course of their medical treatment. All personal patient information will be subject to professional discretion, according to the German Federal Data Privacy Protection Law (Bundesdatenschutzgesetz [BDSG]) and the European Union General Data Protection Regulation. All data interpretation and transmission will be done only via pseudonyms. None of the data will be made available to third parties. Before participation in the trial, all patients will be informed about the nature, course, and risks of the trial in both written and oral form by an investigator. All potential benefits, hazards, and trial-related risks will be explained in detail. The patients’ consent to participate will be documented via signature on a written informed consent form.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flowchart of the SEALIVE trial according to Consolidated Standards of Reporting Trials (CONSORT) guidelines
Fig. 2
Fig. 2
Visit schedule and documentation according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines

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