Siriraj GI Endoscopy Center, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
Division of Gastroenterology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
PLoS One. 2022 Aug 19;17(8):e0272918. doi: 10.1371/journal.pone.0272918. eCollection 2022.
Endoscopic drainage is the primary treatment for unresectable malignant biliary obstruction (MBO). This study developed and validated a pre-endoscopic predictive score for clinical success after stent placement.
Patients with unresectable MBO undergoing ERCP-guided endobiliary stent placement between 2007 and 2017 were randomly divided into derivation (n = 383) and validation (n = 128) cohorts. To develop the risk score, clinical parameters were built by logistic regression to predict (1) ≥ 50% total bilirubin (TB) resolution within 2 weeks and (2) bilirubin normalization (TB level <1.2 mg/dL) within 6 weeks following stenting. The scoring scheme was applied to the validation cohort to test its performance.
A ≥ 50% TB resolution within 2 weeks was shown in 70.5% of cases. The risk scoring scheme had areas under the receiver operating characteristic curve (AUROC) of 0.70 (95% CI, 0.64-0.76) and 0.67 (95% CI, 0.57-0.77) in the derivation and validation cohorts, respectively. Thirty-one percent had TB normalization within 6 weeks after stenting. Significant predictors for TB normalization were extrahepatic biliary obstruction (odds ratio [OR] = 2.35), pre-endoscopic TB level (OR = 0.88), and stent type (OR = 0.42). The AUROC of a risk score for predicting TB normalization within 6 weeks was 0.78 (95% CI, 0.72-0.83) and 0.76 (95% CI, 0.67-0.86) in the derivation and validation cohorts, respectively. A score > 1.30 yielded a specificity of 98% and a positive predictive value of 84% for predicting TB normalization. A score of < -4.18 provided a sensitivity of 80%-90% and a negative predictive value of 90%-93% for predicting the absence of TB normalization.
The pre-endoscopic scoring system comprising biliary obstruction level, liver biochemistry, and type of stent provides prediction indices for TB normalization within 6 weeks after stenting. This scheme may help endoscopists identify patients with unresectable MBO suited for palliative stenting.
内镜引流是治疗不可切除的恶性胆道梗阻（MBO）的主要方法。本研究开发并验证了一种用于预测支架置入后临床成功的内镜前预测评分。
2007 年至 2017 年间，对接受内镜逆行胰胆管造影（ERCP）引导下经内镜胆管内支架置入术的不可切除的 MBO 患者进行随机分组，分为推导组（n = 383）和验证组（n = 128）。通过逻辑回归建立临床参数来预测（1）支架置入后 2 周内总胆红素（TB）降低≥50%和（2）支架置入后 6 周内胆红素正常化（TB 水平<1.2mg/dL）。将评分方案应用于验证组以检验其性能。
70.5%的患者在 2 周内 TB 降低≥50%。推导组和验证组的受试者工作特征曲线（ROC）下面积（AUROC）分别为 0.70（95%CI，0.64-0.76）和 0.67（95%CI，0.57-0.77）。支架置入后 6 周内有 31%的患者 TB 正常化。TB 正常化的显著预测因素为肝外胆道梗阻（比值比[OR] = 2.35）、内镜前 TB 水平（OR = 0.88）和支架类型（OR = 0.42）。预测支架置入后 6 周内 TB 正常化的风险评分 AUROC 分别为推导组 0.78（95%CI，0.72-0.83）和验证组 0.76（95%CI，0.67-0.86）。评分>1.30 预测 TB 正常化的特异性为 98%，阳性预测值为 84%。评分<-4.18 预测 TB 未正常化的敏感性为 80%-90%，阴性预测值为 90%-93%。
由胆道梗阻水平、肝功能和支架类型组成的内镜前评分系统为支架置入后 6 周内 TB 正常化提供了预测指标。该方案可能有助于内镜医生识别适合姑息性支架置入的不可切除 MBO 患者。
