Combined Drainage and Protocolized Necrosectomy Through a Coaxial Lumen-apposing Metal Stent for Pancreatic Walled-off Necrosis: A Prospective Multicenter Trial.
Combined Drainage and Protocolized Necrosectomy Through a Coaxial Lumen-apposing Metal Stent for Pancreatic Walled-off Necrosis: A Prospective Multicenter Trial.
复制标题
通过同轴管腔放置金属支架联合引流和方案坏死切除术治疗胰腺封闭性坏死：一项前瞻性多中心试验。
DOI：
10.1097/sla.0000000000005274
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发表时间：
2023
影响因子：
9
通讯作者：
DeWitt,Joh
中科院分区：
文献类型：
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作者：
Dayyeh,BarhamKAbu;Chandrasekhara,Vinay;Shah,RajJ;Easler,JeffreyJ;Storm,AndrewC;Topazian,Mark;Levy,MichaelJ;Martin,JohnA;Petersen,BretT;Takahashi,Naoki;Edmundowicz,Steven;Hammad,Hazem;Wagh,MihirS;Wani,Sachin;DeWitt,Joh
目的：我们评价了一种使用管腔贴壁金属支架（LAMS）的协议化内镜下坏死切除术方法，用于治疗大的症状性壁状胰腺坏死（WON）患者，包括显著的坏死内容物，伴或不伴infection.Summary背景数据：随机试验显示，与手术治疗感染性WON相比，内镜治疗的疗效相似。设计：我们进行了一项监管性、前瞻性、多中心单臂临床试验，检查内镜超声引导下LAMS与协议化坏死切除术治疗直径≥ 6 cm且固体坏死> 30%的症状性WON的疗效和安全性。LAMS置入后，进行了方案WON评估，并对WON尺寸缩小不充分和持续症状进行了内镜下坏死切除术。影像学WON分辨率≤ 3 cm和/或LAMS留置60天的患者取出LAMS，然后进行6个月随访。主要终点是60天内影像学消退的概率和手术相关的严重不良事件。结果：2018年9月至2020年3月，连续40例患者入组，其中27例（67.5%）为住院患者，19例（47.5%）在首次手术时有感染的临床证据。平均WON尺寸为15.0±5.6 cm，平均53.2%±16.7%固体坏死。60天时，97.5%（95% CI，86.8%，99.9%）的影像学WON消退，34例患者的6个月随访数据无复发。至影像学WON消退的平均时间为34.1±16.8天。3例患者（7.5%）发生严重不良事件，包括败血症、万古霉素耐药肠球菌菌血症和休克以及上消化道出血。没有手术相关的deaths.Conclusions：内镜超声引导下引流与协议内镜坏死切除术治疗大的症状性或感染的封闭坏死胰腺集合是非常有效和安全的。临床试验政府编号：NCT 03525808。
Objective:We evaluated a protocolized endoscopic necrosectomy approach with a lumen-apposing metal stent (LAMS) in patients with large symptomatic walled-off pancreatic necrosis (WON) comprising significant necrotic content, with or without infection.Summary Background Data:Randomized trials have shown similar efficacy of endoscopic treatment compared with surgery for infected WON.Design:We conducted a regulatory, prospective, multicenter single-arm clinical trial examining the efficacy and safety of endoscopic ultrasound-guided LAMS with protocolized necrosectomy to treat symptomatic WON≥ 6 cm in diameter with> 30% solid necrosis. After LAMS placement, protocolized WON assessment was conducted and endoscopic necrosectomy was performed for insufficient WON size reduction and persistent symptoms. Patients with radiographic WON resolution to≤ 3 cm and/or 60-day LAMS indwell had LAMS removal, then 6-month follow-up. Primary endpoints were probability of radiographic resolution by 60 days and procedure-related serious adverse events.Results:Forty consecutive patients were enrolled September 2018 to March 2020, of whom 27 (67.5%) were inpatients and 19 (47.5%) had clinical evidence of infection at their index procedure. Mean WON size was 15.0±5.6 cm with mean 53.2%±16.7% solid necrosis. Radiographic WON resolution was seen in 97.5%(95% CI, 86.8%, 99.9%) by 60 days, without recurrence in 34 patients with 6-month follow-up data. Mean time to radiographic WON resolution was 34.1±16.8 days. Serious adverse events occurred in 3 patients (7.5%), including sepsis, vancomycin-resistant enterococcal bacteremia and shock, and upper gastrointestinal bleeding. There were no procedure-related deaths.Conclusions:Endoscopic ultrasound-guided drainage with protocolized endoscopic necrosectomy to treat large symptomatic or infected walled-off necrotic pancreatic collections was highly effective and safe. Clinicaltrials.-gov no: NCT03525808.