SEALIVE: the use of technical vessel-sealing devices for recipient hepatectomy in liver transplantation: study protocol for a randomized controlled trial.
Houben P, Khajeh E, Hinz U, et al.Trials 19: 380.
Aims
To compare an electrothermal bipolar vessel sealing device (LS; LigaSure™) and an ultrasound dissector (USD; HARMONIC ACE®+7) with standard surgical techniques (control) during the recipients’ hepatectomy in liver transplantation.
Interventions
A single-centre, prospective, randomized, controlled, parallel, three-armed, open trial. Patients will be randomized using a “block randomization†method to receive either LS, USD or standard surgical techniques (control).
Participants
Adults (>18 years) with allocation of a donor liver. Exclusion criteria are emergency liver transplant (LT), previous LT or combined organ transplant. 69 patients will be included in the ITT analysis as ≥23 patients per group are required to confirmed a statistically significant reduction in blood loss (BL) from 1500 ml to 1035 ml with a two-sided t test at a power of 80%, an alpha of 0.025 and a superiority margin of 50 ml.
Outcomes
The primary outcome is total BL during surgical procedure. Secondary outcomes include measures for BL during recipient hepatectomy, duration of surgery, hemodynamic status during surgery, and post-operative assessment of bleeding (coagulation state, hemoglobin level, and transfusions required). Postoperative morbidity will also be recorded and classified. All TEAEs/SAEs and intervention-related AEs will be recorded.
Follow-up
Intraoperative assessment during the hepatectomy and transplant phases. Postoperative day (POD) 1,3,
CET Conclusions
This manuscript describes the protocol for a three-armed RCT comparing use of the ligasure, harmonic ACE and clip/sutures during recipient hepatectomy in liver transplantation. Primary endpoint is intraoperative total blood loss. Secondary endpoints include procedure duration and transfusion requirements. The authors plan to recruit 23 patients to each arm. The methodology is well described, with clear methods of randomization and clearly defined endpoints. Sample size is small, based upon an approximately 1/3 reduction in blood loss comparing either dissection technique to standard care which may be optimistic, but is based upon the authors’ existing experience with the devices. The main challenge is likely to be in recruitment, as most surgeons have a preferred method of haemostasis and may not be prepared to randomize with the risk of not being able to use their preferred device.
Trial registration
ClinicalTrials.gov - NCT03323242