ImportanceThe 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.ObjectiveTo 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 ParticipantsThis 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.InterventionsPatients were randomized (1:1) to receive usual care or a restrictive strategy with stepwise selection for cholecystectomy.Main Outcomes and MeasuresThe 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.ResultsAmong 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.Conclusions and RelevanceIn 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.Trial RegistrationCCMO Identifier: NTR4022

中文翻译：

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腹痛和胆结石患者胆囊切除术的限制性策略与常规护理


重要性SECURE 试验的 1 年结果是一项随机试验，比较了限制性策略与常规护理对特定症状性胆石症患者进行胆囊切除术，结果显示限制性策略后的手术率显著降低。然而，限制性策略并未导致 1 年时更多无痛患者。目的 测量疼痛程度，确定 5 年随访时无痛患者比例、手术率、胆道和手术并发症。设计、设置和参与者这项随机临床试验是一项多中心、平行臂、非劣效性、前瞻性研究。在 2014 年 2 月至 2017 年 4 月期间，纳入了来自 24 家医院的有症状、无并发症的胆石症患者。单纯性胆石症被定义为没有复杂性胆石症体征的胆石病，即胆汁性胰腺炎、胆管炎、胆总管结石或胆囊炎。该分析的随访数据是在 2019 年 7 月 11 日至 2023 年 9 月 23 日通过电话收集的。主要结局和测量主要的非劣效性终点是在 5 年随访中通过 Izbicki 疼痛评分评估无痛的患者比例。选择了 5% 的非劣效性边际。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。结果1067 例患者中，中位 （IQR） 年龄为 49.0 岁 （38.0-59.0 岁）;女性 786 例 （73.7%），男性 281 例 （26.3%）。在 5 年随访中，常规护理组 363 名患者中有 228 名 （62.8%） 无痛，而 353 名患者中有 216 名 （61.2%）在限制性策略组中 （差异，1.6%;1 侧 95% 置信下限，-7.6%;非劣效性 P = .18）。胆囊切除术后，常规护理组 294 例患者中有 187 例 （63.6%） 和限制策略组 254 例患者中有 160 例 （63.0%） 无痛 （P = .88）。限制性护理策略与 529 例胆囊切除术中的 387 例 （73.2%） 相关，而常规护理组 536 例中的 437 例 （81.5%;差异 8.3%;P = .001）。在胆道和手术并发症或患者满意度方面未观察到组间差异。结论和相关性从长期来看，与常规护理相比，限制性策略导致手术率显著降低但幅度较小，并且与胆道和手术并发症的增加无关。然而，无论采用何种策略，只有 2/3 的患者没有疼痛。选择无并发症胆石症患者进行胆囊切除术的进一步标准，并重新考虑腹腔镜胆石切除术作为治疗，以改善患者报告的结局。Trial RegistrationCCMO 标识符： NTR4022