Houben Philipp, Khajeh Elias, Hinz Ulf, Knebel Phillip, Diener Markus K, Mehrabi Arianeb
Department of General, Visceral, and Transplant Surgery, University Hospital Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.
Trials. 2018 Jul 16;19(1):380. doi: 10.1186/s13063-018-2778-1.
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.
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.
ClinicalTrials.gov, NCT 03323242 . Registered on October 26, 2017.
肝移植手术技术一直在不断发展，旨在形成一种安全、高度标准化的手术方法。尽管如此，受体肝切除术的初始步骤迄今为止尚未成为临床研究的重点。由于肝移植受体存在严重凝血功能障碍，手术的这一部分仍存在严重出血风险。本试验旨在比较肝移植受体肝切除术过程中，电热双极血管闭合装置（LigaSure™）和超声切割止血刀（HARMONIC ACE®+7）与标准手术技术的效果。
方法/设计：在一项单中心、前瞻性、随机、对照、平行、三臂、验证性开放试验中，将LigaSure™和HARMONIC ACE®+7与肝移植受体肝切除术过程中使用钛夹和传统打结结扎的标准手术技术进行比较。术中总失血量是试验的主要终点。次要终点包括肝切除术中的失血量、肝切除术和整个手术过程的持续时间以及手术的输血需求。为了获得可靠数据，术中失血量将根据手术期间所有冲洗液、腹水情况以及对用过的拭子称重来记录。在两个实验组的检验效能为80%且α为0.025的情况下，每个研究组将按照方案分析23名受试者，以检测术中失血量的临床相关减少情况。意向性分析将包括69名患者。出于安全考虑，每位患者的随访期为90天，而所有临床结局将在术后前10天内进行测量。
据我们所知，这是第一项前瞻性、随机试验，比较两种创新的血管闭合和解剖技术与受体肝切除术的标准技术。这样做是为了检测肝移植术中相关的术中失血量减少情况。预计该试验结果将改善肝移植术后患者的结局和安全性，并提高该手术的总体安全性。
ClinicalTrials.gov，NCT 03323242。于2017年10月26日注册。
