Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, Shanghai, China; National Clinical Research Center for Digestive Diseases, Shanghai, China; Shanghai Institute of Pancreatic Diseases, Shanghai, China.
Department of Anesthesiology, Changhai Hospital, Shanghai, China.
Lancet Gastroenterol Hepatol. 2022 Mar;7(3):238-244. doi: 10.1016/S2468-1253(21)00434-9. Epub 2022 Jan 25.
Pancreatitis is the most common complication of pancreatic extracorporeal shock wave lithotripsy (ESWL). There has been little research into effective prevention of post-ESWL pancreatitis. Therefore, we aimed to assess the efficacy of prophylactic rectal indometacin in preventing post-ESWL pancreatitis.
In this double-blind, randomised, placebo-controlled trial done at Changhai Hospital (Shanghai, China), patients aged 18 years or older with chronic pancreatitis and pancreatic stones (>5 mm in diameter) who were eligible for treatment with ESWL were randomly allocated using a computer-generated randomisation table, in a 1:1 ratio, to receive 100 mg rectal indometacin or identical glycerin (placebo) suppositories 30 min before ESWL. Patients, endoscopists, and outcome assessors were masked to group allocation. The primary outcome was the incidence of post-ESWL pancreatitis within 24 h of ESWL, analysed by the intention-to-treat principle. This study is registered with ClinicalTrials.gov, number NCT02797067.
Between May 31, 2016, and June 26, 2019, 1370 patients were enrolled, with 685 patients randomly assigned to the rectal indometacin group and 685 patients to the placebo group. All patients received their allocated intervention and completed final follow-up, and were included in the intention-to-treat analysis. Post-ESWL pancreatitis occurred in 60 (9%) patients in the rectal indometacin group and 84 (12%) patients in the placebo group (relative risk 0·71, 95% CI 0·52-0·98; p=0·042). Transient adverse events occurred in 235 (34%) patients in the rectal indometacin group and 252 (37%) patients in the placebo group, with asymptomatic hyperamylasaemia being the most common (189 [28%] patients vs 197 [29%] patients). No difference was noted between groups in the incidence of other complications and transient adverse events.
Pre-procedural administration of rectal indometacin is an efficacious and safe means of reducing the incidence of post-ESWL pancreatitis.
Programs of Shanghai Municipal Government and the "Ten Thousand Plan"-National High Level Talents Special Support Plan.
胰腺炎是体外冲击波碎石术（ESWL）后最常见的并发症。目前，对于预防 ESWL 后胰腺炎，还没有太多有效的研究。因此，我们旨在评估直肠吲哚美辛预防 ESWL 后胰腺炎的疗效。
本研究在上海长海医院进行，采用双盲、随机、安慰剂对照试验设计，纳入年龄在 18 岁及以上、患有慢性胰腺炎和胰腺结石（直径＞5mm）、符合 ESWL 治疗指征的患者，使用计算机生成的随机数表，按照 1:1 的比例，将患者随机分为直肠吲哚美辛组或相同剂量甘油（安慰剂）栓剂组，在 ESWL 前 30min 用药。患者、内镜医师和结局评估者对分组情况设盲。主要结局是 ESWL 后 24h 内发生的 ESWL 后胰腺炎的发生率，采用意向治疗原则进行分析。该研究在 ClinicalTrials.gov 注册，编号为 NCT02797067。
2016 年 5 月 31 日至 2019 年 6 月 26 日，共纳入 1370 例患者，685 例患者被随机分配至直肠吲哚美辛组，685 例患者被分配至安慰剂组。所有患者均接受了各自的干预措施，并完成了最终随访，纳入意向治疗分析。直肠吲哚美辛组有 60（9%）例患者发生 ESWL 后胰腺炎，安慰剂组有 84（12%）例患者发生 ESWL 后胰腺炎（相对风险 0.71，95%CI 0.52-0.98；p=0.042）。直肠吲哚美辛组有 235（34%）例患者发生短暂性不良事件，安慰剂组有 252（37%）例患者发生短暂性不良事件，最常见的是无症状性高淀粉酶血症（189[28%]例患者 vs 197[29%]例患者）。两组在其他并发症和短暂性不良事件的发生率方面无差异。
术前应用直肠吲哚美辛可有效降低 ESWL 后胰腺炎的发生率，且安全。
上海市政府计划项目和“万人计划”-国家高层次人才特殊支持计划。
