腹痛和胆结石患者胆囊切除术的限制性策略与常规护理:SECURE 随机临床试验的 5 年随访。

IF 15.7 1区 医学 Q1 SURGERY JAMA surgery Pub Date : 2024-08-21 DOI:10.1001/jamasurg.2024.3080
Daan J Comes, Sarah Z Wennmacker, Carmen S S Latenstein, Jarmila van der Bilt, Otmar Buyne, Sandra C Donkervoort, Joos Heisterkamp, Klaas In't Hof, Jan Jansen, Vincent B Nieuwenhuijs, Pascal Steenvoorde, Hein B A C Stockmann, Djamila Boerma, Joost P H Drenth, Cornelis J H M van Laarhoven, Marja A Boermeester, Marcel G W Dijkgraaf, Philip R de Reuver
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引用次数: 0

摘要

重要性:SECURE 试验是一项随机试验,比较了对有症状的胆石症患者进行胆囊切除术时的限制性策略和常规护理,结果显示,采用限制性策略后,手术率明显降低。然而,限制性策略并没有使更多患者在一年后无痛:测量疼痛程度,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:这项随机临床试验是一项多中心、平行臂、非劣效、前瞻性研究。2014年2月至2017年4月期间,来自24家医院的无症状、无并发症胆石症患者被纳入其中。无并发症胆石症是指没有并发症胆石症症状的胆石症,即胆源性胰腺炎、胆管炎、胆总管结石或胆囊炎。本次分析的随访数据是在2019年7月11日至2023年9月23日期间通过电话收集的:患者随机(1:1)接受常规护理或限制性策略,逐步选择胆囊切除术:主要非劣效性终点是随访 5 年时通过 Izbicki 疼痛评分评估的无痛患者比例。选择的非劣效边际为 5%。次要终点包括胆囊切除率、胆道和手术并发症以及患者满意度:在1067名患者中,中位(IQR)年龄为49.0岁(38.0-59.0岁);786人(73.7%)为女性,281人(26.3%)为男性。在 5 年随访中,常规护理组的 363 名患者中有 228 名(62.8%)无痛,而限制性策略组的 353 名患者中有 216 名(61.2%)无痛(差异为 1.6%;单侧 95% 置信下限为-7.6%;非劣效 P = .18)。胆囊切除术后,常规护理组 294 名患者中的 187 名(63.6%)和限制性策略组 254 名患者中的 160 名(63.0%)分别无痛(P = .88)。在 529 例胆囊切除术中,采用限制性护理策略的有 387 例(73.2%),而在常规护理组的 536 例胆囊切除术中,采用限制性护理策略的有 437 例(81.5%;相差 8.3%;P = .001)。在胆道并发症和手术并发症以及患者满意度方面,各组之间未发现差异:从长期来看,与常规护理相比,限制性策略可显著降低手术率,但降低幅度较小,且与胆道和手术并发症的增加无关。然而,无论采用哪种策略,只有三分之二的患者能够摆脱疼痛。为改善患者报告的结果,需要进一步制定标准,选择无并发症胆石症患者进行胆囊切除术,并重新思考腹腔镜胆囊切除术的治疗方法:试验注册:CCMO Identifier:NTR4022.
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Restrictive Strategy vs Usual Care for Cholecystectomy in Patients With Abdominal Pain and Gallstones: 5-Year Follow-Up of the SECURE Randomized Clinical Trial.

Importance: 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.

Objective: 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.

Interventions: Patients were randomized (1:1) to receive usual care or a restrictive strategy with stepwise selection for cholecystectomy.

Main outcomes and measures: 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.

Results: 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.

Conclusions and relevance: 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.

Trial registration: CCMO Identifier: NTR4022.

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来源期刊
JAMA surgery
JAMA surgery SURGERY-
CiteScore
20.80
自引率
3.60%
发文量
400
期刊介绍: JAMA Surgery, an international peer-reviewed journal established in 1920, is the official publication of the Association of VA Surgeons, the Pacific Coast Surgical Association, and the Surgical Outcomes Club.It is a proud member of the JAMA Network, a consortium of peer-reviewed general medical and specialty publications.
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