Department of Surgery, Radboud University Medical Center, Nijmegen, the Netherlands.
Department of Operating Rooms, Radboud University Medical Center, Nijmegen, the Netherlands.
JAMA Surg. 2021 Oct 1;156(10):e213706. doi: 10.1001/jamasurg.2021.3706. Epub 2021 Oct 13.
There is currently no consensus on the indication for cholecystectomy in patients with uncomplicated gallstone disease.
To report on the development and validation of a multivariable prediction model to better select patients for surgery.
DESIGN, SETTING, AND PARTICIPANTS: This study evaluates data from 2 multicenter prospective trials (the previously published Scrutinizing (In)efficient Use of Cholecystectomy: A Randomized Trial Concerning Variation in Practice [SECURE] and the Standardized Work-up for Symptomatic Cholecystolithiasis [Success] trial) collected from the outpatient clinics of 25 Dutch hospitals between April 2014 and June 2019 and including 1561 patients with symptomatic uncomplicated cholelithiasis, defined as gallstone disease without signs of complicated cholelithiasis (ie, biliary pancreatitis, cholangitis, common bile duct stones or cholecystitis). Data were analyzed from January 2020 to June 2020.
Patient characteristics, comorbidity, surgical outcomes, pain, and symptoms measured at baseline and at 6 months' follow-up.
A multivariable regression model to predict a pain-free state or a clinically relevant reduction in pain after surgery. Model performance was evaluated using calibration and discrimination.
A total of 1561 patients were included (494 patients in 7 hospitals in the development cohort and 1067 patients in 24 hospitals in the validation cohort; 6 hospitals included patients in both cohorts). In the development cohort, 395 patients (80.0%) underwent cholecystectomy. After surgery, 225 patients (57.0%) reported that they were pain free and 295 (74.7%) reported a clinically relevant reduction in pain. A multivariable prediction model showed that increased age, no history of abdominal surgery, increased visual analog scale pain score at baseline, pain radiation to the back, pain reduction with simple analgesics, nausea, and no heartburn were independent predictors of clinically relevant pain reduction after cholecystectomy. After internal validation, good discrimination was found (C statistic, 0.80; 95% CI, 0.74-0.84) between patients with and without clinically relevant pain reduction. The model had very good overall calibration and minimal underestimation of the probability. External validation indicated a good discrimination between patients with and without clinically relevant pain reduction (C statistic, 0.74; 95% CI, 0.70-0.78) and fair calibration with some overestimation of probability by the model.
The model validated in this study may help predict the probability of pain reduction after cholecystectomy and thus aid surgeons in deciding whether patients with uncomplicated cholelithiasis will benefit from cholecystectomy.
目前对于没有并发症的胆囊结石病患者，胆囊切除术的适应证尚无共识。
报告一种多变量预测模型的开发和验证情况，以便更好地选择手术患者。
设计、地点和参与者：本研究评估了 2014 年 4 月至 2019 年 6 月期间，来自荷兰 25 家医院门诊的 2 项多中心前瞻性试验（先前发表的 Scrutinizing (In)efficient Use of Cholecystectomy: A Randomized Trial Concerning Variation in Practice [SECURE] 和 Standardized Work-up for Symptomatic Cholecystolithiasis [Success] 试验）的数据，共纳入 1561 例有症状的单纯性胆囊结石病患者，定义为无复杂胆石症迹象的胆石症（即胆石性胰腺炎、胆管炎、胆总管结石或胆囊炎）。数据分析于 2020 年 1 月至 2020 年 6 月进行。
患者特征、合并症、手术结果、基线和 6 个月随访时的疼痛和症状。
预测手术后无疼痛状态或疼痛明显减轻的多变量回归模型。通过校准和区分度评估模型性能。
共纳入 1561 例患者（开发队列中有 494 例患者，在 7 家医院就诊；验证队列中有 1067 例患者，在 24 家医院就诊；6 家医院的患者同时入组了两个队列）。在开发队列中，395 例（80.0%）患者接受了胆囊切除术。术后，225 例（57.0%）患者报告无疼痛，295 例（74.7%）患者报告疼痛明显减轻。多变量预测模型显示，年龄增加、无腹部手术史、基线视觉模拟评分疼痛增加、疼痛放射至背部、疼痛减轻与简单止痛药物、恶心、无烧心是胆囊切除术后疼痛明显减轻的独立预测因素。内部验证后发现，模型在预测患者有无明显疼痛减轻方面具有良好的区分度（C 统计量为 0.80；95%CI，0.74-0.84）。模型的整体校准情况非常好，概率低估程度极小。外部验证表明，模型在预测患者有无明显疼痛减轻方面具有良好的区分度（C 统计量为 0.74；95%CI，0.70-0.78），但校准情况一般，模型对概率的估计略有偏高。
本研究验证的模型可能有助于预测胆囊切除术后疼痛减轻的概率，从而帮助外科医生决定是否对患有单纯性胆囊结石病的患者进行胆囊切除术。
