Lera Dos Santos Marcos Eduardo, Proença Igor Mendonça, de Moura Diogo Turiani Hourneaux, Ribeiro Igor Braga, Matuguma Sergio Eiji, Cheng Spencer, de Freitas Júnior João Remi, Luz Gustavo de Oliveira, McCarty Thomas R, Jukemura José, de Moura Eduardo Guimarães Hourneaux
Serviço de Endoscopia Gastrointestinal do Departamento de Gastroenterologia, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), São Paulo, BRA.
Serviço de Endoscopia Gastrointestinal do Departamento de Gastroenterologia, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Sao Paulo, BRA.
Cureus. 2023 Apr 17;15(4):e37731. doi: 10.7759/cureus.37731. eCollection 2023 Apr.
Background and aim Endoscopic ultrasound (EUS)-guided drainage is the gold standard approach for the treatment of encapsulated pancreatic collections (EPCs) including pseudocyst and walled-off pancreatic necrosis (WON), and is associated with an equivalent clinical efficacy to surgical drainage with fewer complications and less morbidity. Drainage may be achieved via several types of stents including a fully covered self-expandable metallic stent (SEMS) and lumen-apposing metal stent (LAMS). However, to date there have been no randomized trials to compare these devices. This study aimed to compare the efficacy and safety of the SEMS versus LAMS for EUS-guided drainage of EPCs. Methods A phase IIB randomized trial was designed to compare the SEMS versus LAMS for the treatment of EPCs. Technical success, clinical success, adverse events (AEs), and procedure time were evaluated. A sample size of 42 patients was determined. Results There was no difference between the two groups in technical (LAMS 80.95% vs 100% SEMS, p=0.107), clinical (LAMS 85.71% vs 95.24% SEMS, p=0.606) or radiological success (LAMS 92.86% vs 83.33% SEMS, p=0.613). There was no difference in AEs including stent migration rate and mortality. The procedure time was longer in the LAMS group (mean time 43.81 min versus 24.43 min, p=0.001). There was also a difference in the number of intra-procedure complications (5 LAMS vs 0 SEMS, p=0.048). Conclusion SEMS and LAMS have similar technical, clinical, and radiological success as well as AEs. However, SEMS has a shorter procedure time and fewer intra-procedure complications compared to non-electrocautery-enhanced LAMS in this phase IIB randomized controlled trial (RCT). The choice of the type of stent used for EUS drainage of EPCs should consider device availability, costs, and personal and local experience.
背景与目的 内镜超声（EUS）引导下引流是治疗包括假性囊肿和包裹性胰腺坏死（WON）在内的包裹性胰腺液体积聚（EPC）的金标准方法，其临床疗效与手术引流相当，但并发症更少、发病率更低。可通过多种类型的支架实现引流，包括全覆膜自膨式金属支架（SEMS）和管腔对吻金属支架（LAMS）。然而，迄今为止尚无随机试验对这些器械进行比较。本研究旨在比较SEMS与LAMS用于EUS引导下EPC引流的疗效和安全性。方法 设计一项IIB期随机试验，比较SEMS与LAMS治疗EPC的效果。评估技术成功率、临床成功率、不良事件（AE）和操作时间。确定样本量为42例患者。结果 两组在技术成功率（LAMS 80.95% 对SEMS 100%，p = 0.107）、临床成功率（LAMS 85.71% 对SEMS 95.24%，p = 0.606）或影像学成功率（LAMS 92.86% 对SEMS 83.33%，p = 0.613）方面无差异。在包括支架移位率和死亡率在内的AE方面也无差异。LAMS组的操作时间更长（平均时间43.81分钟对24.43分钟，p = 0.001）。术中并发症数量也存在差异（LAMS组5例对SEMS组0例，p = 0.048）。结论 SEMS和LAMS在技术、临床和影像学成功率以及AE方面相似。然而，在这项IIB期随机对照试验（RCT）中，与非电灼增强型LAMS相比，SEMS的操作时间更短，术中并发症更少。用于EPC的EUS引流的支架类型选择应考虑器械可用性、成本以及个人和当地经验。
