Boxhoorn Lotte, Verdonk Robert C, Besselink Marc G, Boermeester Marja, Bollen Thomas L, Bouwense Stefan Aw, Cappendijk Vincent C, Curvers Wouter L, Dejong Cornelis H, van Dijk Sven M, van Dullemen Hendrik M, van Eijck Casper Hj, van Geenen Erwin Jm, Hadithi Muhammed, Hazen Wouter L, Honkoop Pieter, van Hooft Jeanin E, Jacobs Maarten Ajm, Kievits June Ec, Kop Marnix Pm, Kouw Eva, Kuiken Sjoerd D, Ledeboer Michiel, Nieuwenhuijs Vincent B, Perk Lars E, Poley Jan-Werner, Quispel Rutger, de Ridder Rogier Jj, van Santvoort Hjalmar C, Sperna Weiland Christina J, Stommel Martijn Wj, Timmerhuis Hester C, Witteman Ben J, Umans Devica S, Venneman Niels G, Vleggaar Frank P, van Wanrooij Roy Lj, Bruno Marco J, Fockens Paul, Voermans Rogier P
Department of Gastroenterology and Hepatology, Amsterdam UMC, location University of Amsterdam, Amsterdam, The Netherlands.
Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands.
Gut. 2023 Jan;72(1):66-72. doi: 10.1136/gutjnl-2021-325632. Epub 2022 Jun 14.
Lumen-apposing metal stents (LAMS) are believed to clinically improve endoscopic transluminal drainage of infected necrosis when compared with double-pigtail plastic stents. However, comparative data from prospective studies are very limited.
Patients with infected necrotising pancreatitis, who underwent an endoscopic step-up approach with LAMS within a multicentre prospective cohort study were compared with the data of 51 patients in the randomised TENSION trial who had been assigned to the endoscopic step-up approach with double-pigtail plastic stents. The clinical study protocol was otherwise identical for both groups. Primary end point was the need for endoscopic transluminal necrosectomy. Secondary end points included mortality, major complications, hospital stay and healthcare costs.
A total of 53 patients were treated with LAMS in 16 hospitals during 27 months. The need for endoscopic transluminal necrosectomy was 64% (n=34) and was not different from the previous trial using plastic stents (53%, n=27)), also after correction for baseline characteristics (OR 1.21 (95% CI 0.45 to 3.23)). Secondary end points did not differ between groups either, which also included bleeding requiring intervention-5 patients (9%) after LAMS placement vs 11 patients (22%) after placement of plastic stents (relative risk 0.44; 95% CI 0.16 to 1.17). Total healthcare costs were also comparable (mean difference -€6348, bias-corrected and accelerated 95% CI -€26 386 to €10 121).
Our comparison of two patient groups from two multicentre prospective studies with a similar design suggests that LAMS do not reduce the need for endoscopic transluminal necrosectomy when compared with double-pigtail plastic stents in patients with infected necrotising pancreatitis. Also, the rate of bleeding complications was comparable.
与双猪尾塑料支架相比，管腔贴附金属支架（LAMS）被认为可在临床上改善感染性坏死的内镜下经腔引流。然而，前瞻性研究的比较数据非常有限。
在一项多中心前瞻性队列研究中，对接受LAMS内镜逐步治疗的感染性坏死性胰腺炎患者与随机分组的TENSION试验中51例接受双猪尾塑料支架内镜逐步治疗的患者的数据进行比较。两组的临床研究方案在其他方面相同。主要终点是内镜下经腔坏死组织清除术的必要性。次要终点包括死亡率、主要并发症、住院时间和医疗费用。
在27个月内，16家医院共有53例患者接受了LAMS治疗。内镜下经腔坏死组织清除术的必要性为64%（n = 34），与之前使用塑料支架的试验（53%，n = 27）相比无差异，校正基线特征后也是如此（比值比1.21（95%置信区间0.45至3.23））。两组的次要终点也无差异，其中还包括需要干预的出血——LAMS置入后5例患者（9%），塑料支架置入后11例患者（22%）（相对风险0.44；95%置信区间0.16至1.17）。总医疗费用也相当（平均差异-6348欧元，偏差校正和加速95%置信区间-26386欧元至10121欧元）。
我们对两项设计相似的多中心前瞻性研究中的两组患者进行的比较表明，在感染性坏死性胰腺炎患者中，与双猪尾塑料支架相比，LAMS并未减少内镜下经腔坏死组织清除术的必要性。此外，出血并发症的发生率相当。
