Department of Surgery, Radboud University Medical Centre, Nijmegen, the Netherlands.
Department of Surgery, Flevoziekenhuis, Almere, the Netherlands.
JAMA Surg. 2024 Nov 1;159(11):1235-1243. doi: 10.1001/jamasurg.2024.3080.
The 1-year results of the SECURE trial, a randomized trial comparing a restrictive strategy vs usual care for select patients with symptomatic cholelithiasis for cholecystectomy, resulted in a significantly lower operation rate after restrictive strategy. However, a restrictive strategy did not result in more pain-free patients at 1 year.
To gauge pain level and determine the proportion of pain-free patients, operation rate, and biliary and surgical complications at the 5-year follow-up.
DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial was a multicenter, parallel-arm, noninferiority, prospective study. Between February 2014 and April 2017, patients from 24 hospitals with symptomatic, uncomplicated cholelithiasis were included. Uncomplicated cholelithiasis was defined as gallstone disease without signs of complicated cholelithiasis, ie, biliary pancreatitis, cholangitis, common bile duct stones, or cholecystitis. Follow-up data for this analysis were collected by telephone from July 11, 2019, to September 23, 2023.
Patients were randomized (1:1) to receive usual care or a restrictive strategy with stepwise selection for cholecystectomy.
The primary, noninferiority end point was proportion of patients who were pain free as evaluated by Izbicki pain score at the 5-year follow-up. A 5% noninferiority margin was chosen. The secondary end points included cholecystectomy rates, biliary and surgical complications, and patient satisfaction.
Among 1067 patients, the median (IQR) age was 49.0 years (38.0-59.0 years); 786 (73.7%) were female, and 281 (26.3%) were male. At the 5-year follow-up, 228 of 363 patients (62.8%) were pain free in the usual care group, compared with 216 of 353 patients (61.2%) in restrictive strategy group (difference, 1.6%; 1-sided 95% lower confidence limit, -7.6%; noninferiority P = .18). After cholecystectomy, 187 of 294 patients (63.6%) in the usual care group and 160 of 254 patients (63.0%) in the restrictive strategy group were pain free, respectively (P = .88). The restrictive care strategy was associated with 387 of 529 cholecystectomies (73.2%) compared with 437 of 536 in the usual care group (81.5%; 8.3% difference; P = .001). No differences between groups were observed in biliary and surgical complications or in patient satisfaction.
In the long-term, a restrictive strategy results in a significant but small reduction in operation rate compared with usual care and is not associated with increased biliary and surgical complications. However, regardless of the strategy, only two-third of patients were pain free. Further criteria for selecting patients with uncomplicated cholelithiasis for cholecystectomy and rethinking laparoscopic cholecystectomy as treatment is needed to improve patient-reported outcomes.
CCMO Identifier: NTR4022.
SECURE 试验的 1 年结果显示，与常规治疗相比，对有症状的胆囊结石患者进行选择性胆囊切除术的限制策略导致手术后率显著降低。然而，限制策略并没有导致更多的患者在 1 年内没有疼痛。
评估疼痛程度，并确定 5 年随访时无痛患者的比例、手术率、胆道和手术并发症。
设计、地点和参与者：这是一项多中心、平行臂、非劣效性、前瞻性研究。2014 年 2 月至 2017 年 4 月，来自 24 家医院的有症状、无并发症的胆石症患者参与了该研究。无并发症的胆石症定义为没有复杂胆石症迹象的胆石病，即胰腺炎、胆管炎、胆总管结石或胆囊炎。本分析的随访数据于 2019 年 7 月 11 日至 2023 年 9 月 23 日通过电话收集。
患者随机（1:1）接受常规护理或限制策略，逐步选择胆囊切除术。
主要的非劣效性终点是在 5 年随访时用 Izbicki 疼痛评分评估的无痛患者比例。选择了 5%的非劣效性边界。次要终点包括胆囊切除术率、胆道和手术并发症以及患者满意度。
在 1067 名患者中，中位数（IQR）年龄为 49.0 岁（38.0-59.0 岁）；786 名（73.7%）为女性，281 名（26.3%）为男性。在 5 年随访时，常规护理组 363 名患者中有 228 名（62.8%）无痛，限制策略组 353 名患者中有 216 名（61.2%）无痛（差异 1.6%；单侧 95%置信下限 -7.6%；非劣效性 P=0.18）。在胆囊切除术后，常规护理组 294 名患者中有 187 名（63.6%）无痛，限制策略组 254 名患者中有 160 名（63.0%）无痛（P=0.88）。限制护理策略与 529 例胆囊切除术相关，而常规护理组为 536 例（73.2%比 81.5%；8.3%差异；P=0.001）。两组在胆道和手术并发症或患者满意度方面均无差异。
长期来看，与常规护理相比，限制策略会显著降低手术率，但与增加的胆道和手术并发症无关。然而，无论采用哪种策略，只有三分之二的患者没有疼痛。需要进一步制定选择有症状胆囊结石患者进行胆囊切除术的标准，并重新考虑腹腔镜胆囊切除术作为治疗方法，以改善患者报告的结果。
CCMO 标识符：NTR4022。
