Müssle Benjamin, Zühlke Leonie, Wierick Ann, Sturm Dorothée, Grählert Xina, Distler Marius, Rahbari Nuh N, Weitz Jürgen, Welsch Thilo
Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Technische Universität, Dresden, Germany.
Coordination Centre for Clinical Trials, Faculty of Medicine Carl Gustav Carus, Technische Universität, Dresden, Germany.
Trials. 2018 Apr 12;19(1):222. doi: 10.1186/s13063-018-2580-0.
The purpose of this study is to evaluate whether wrapping of the pedicled falciform ligamentum flap around the gastroduodenal artery (GDA) stump/hepatic artery can significantly decrease the incidence of erosion hemorrhage after pancreatoduodenectomy (PD).
METHODS/DESIGN: This is a randomized controlled multicenter trial involving 400 patients undergoing PD. Patients will be randomized into two groups. The intervention group consists of 200 patients with a prophylactic wrapping of the GDA stump using the pedicled falciform ligament. The control group consists of 200 patients without the wrap. The primary endpoint is the rate of postoperative erosion hemorrhage of the GDA stump or hepatic artery within 3 months. The secondary endpoints are postpancreatectomy hemorrhage stratified according to the texture of the pancreas, postoperative pancreatic fistula (POPF), postoperative rate of therapeutic interventions, morbidity, and mortality.
Only few retrospective studies investigated the effectiveness of a falciform ligament wrap around the GDA for prevention of erosion hemorrhage. Erosion hemorrhage occurs in up to 6-9% of cases after PD and is most frequently evoked by a POPF. Erosion hemorrhage is associated with a remarkable mortality of over 30%. The rate of hemorrhage after performing the wrap is reported to be low. However, there exist no prospectively controlled data to support its general use. Therefore, the presented randomized controlled trial will provide clinically relevant evidence of the effectiveness of the wrap with statistical significance.
clinicaltrials.gov, NCT02588066 ; Registered on 27 October 2015.
本研究旨在评估带蒂镰状韧带瓣包裹胃十二指肠动脉（GDA）残端/肝动脉是否能显著降低胰十二指肠切除术（PD）后侵蚀性出血的发生率。
方法/设计：这是一项随机对照多中心试验，涉及400例行PD的患者。患者将被随机分为两组。干预组由200例使用带蒂镰状韧带预防性包裹GDA残端的患者组成。对照组由200例未进行包裹的患者组成。主要终点是3个月内GDA残端或肝动脉术后侵蚀性出血的发生率。次要终点是根据胰腺质地分层的胰十二指肠切除术后出血、术后胰瘘（POPF）、术后治疗干预率、发病率和死亡率。
仅有少数回顾性研究调查了镰状韧带包裹GDA预防侵蚀性出血的有效性。PD术后高达6-9%的病例会发生侵蚀性出血，最常见的诱因是POPF。侵蚀性出血的死亡率高达30%以上。据报道，进行包裹后的出血率较低。然而，尚无前瞻性对照数据支持其广泛应用。因此，本随机对照试验将提供具有统计学意义的包裹有效性的临床相关证据。
clinicaltrials.gov，NCT02588066；于2015年10月27日注册。
