ERCP下胆管及胆囊内引流治疗急性胆囊炎合并胆管炎疗效及其预测模型构建

doi:10.3877/cma.j.issn.2095-3232.2026.05.010

中华肝脏外科手术学电子杂志 ›› 2026, Vol. 15 ›› Issue (05) : 750 -759. doi: 10.3877/cma.j.issn.2095-3232.2026.05.010

临床研究

ERCP下胆管及胆囊内引流治疗急性胆囊炎合并胆管炎疗效及其预测模型构建

郑海明¹, 廖祥伟¹, 黎文华², 翟颖¹, 郭阳¹, 周尊强³, 宛新建¹^,^†(

)

¹　200233　上海交通大学医学院附属第六人民医院消化科及消化内镜中心
³　200233　上海交通大学医学院附属第六人民医院普外科
²　200235　上海市第八人民医院消化内科

收稿日期:2026-04-12 出版日期:2026-10-10
通信作者: 宛新建
基金资助:
国家自然科学基金(82374215); 上海交通大学医学院消化科学院资助项目(KY-2023-06-02，KY-2023-06-01); 上海交通大学医工交叉资助项目(YG2023ZD20)

Clinical efficacy and construction of prediction model of ERCP plus biliary drainage combined with gallbladder drainage for acute cholecystitis complicated with cholangitis

Haiming Zheng¹, Xiangwei Liao¹, Wenhua Li², Ying Zhai¹, Yang Guo¹, Zunqiang Zhou³, Xinjian Wan¹^,^†()

¹ Department of Gastroenterology & Gastroenteroscopy Center, Shanghai Sixth People's Hospital affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai 200233, China
³ Department of General Surgery, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai 200233, China
² Department of Gastroenterology, Shanghai 8th People's Hospital, Shanghai 200235, China

Received:2026-04-12 Published:2026-10-10
Corresponding author: Xinjian Wan

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引用本文：

郑海明, 廖祥伟, 黎文华, 翟颖, 郭阳, 周尊强, 宛新建. ERCP下胆管及胆囊内引流治疗急性胆囊炎合并胆管炎疗效及其预测模型构建[J/OL]. 中华肝脏外科手术学电子杂志, 2026, 15(05): 750-759.

Haiming Zheng, Xiangwei Liao, Wenhua Li, Ying Zhai, Yang Guo, Zunqiang Zhou, Xinjian Wan. Clinical efficacy and construction of prediction model of ERCP plus biliary drainage combined with gallbladder drainage for acute cholecystitis complicated with cholangitis[J/OL]. Chinese Journal of Hepatic Surgery(Electronic Edition), 2026, 15(05): 750-759.

目的

探讨ERCP下胆管及胆囊内引流治疗急性胆囊炎合并胆管炎的有效性和安全性并构建疗效预测模型。

方法

回顾性分析2022年9月至2024年4月在上海交通大学医学院附属第六人民医院接受ERCP治疗的77例急性胆囊炎合并胆管炎患者临床资料。患者均签署知情同意书，符合医学伦理学规定。其中男44例，女33例；年龄61~86岁，中位年龄为70岁。根据ERCP下胆囊内引流是否成功分为胆囊内引流成功组和胆囊内引流失败组，成功组采用ERCP下胆管取石/胆管引流+胆囊内引流；失败组在胆管取石/引流基础上，部分患者采用经皮胆囊穿刺引流或手术切除胆囊。观察并记录两组患者技术成功率、临床缓解率、术后不良事件等指标。采用Logistic多因素回归分析胆囊内引流失败的独立危险因素。绘制ROC曲线分析回归模型对胆囊内引流成功率预测价值。

结果

患者临床缓解率99%（76/77），因急诊操作条件有限，ERCP下胆囊内引流成功率为42%（32/77）。胆囊内引流失败率为58%（45/77），其中12例在分别行胆囊穿刺或急诊外科手术后炎症得以控制，1例多器官功能衰竭死亡，其余临床缓解。两组间不良事件发生率及复发率比较差异均无统计学意义（P>0.05）。术后高淀粉酶血症5例，未做特殊处理后好转。无出血、穿孔等。胆囊内引流成功组术后轻型胰腺炎1例，经内科保守治疗后好转；1例术后肺部感染，经抗感染治疗后好转。ERCP术后6个月内胆系感染复发6例，其中胆囊内引流失败组5例，胆囊内引流成功组1例。Logistic多因素回归分析显示，胃改道术后（OR=31.775，95%CI：1.711~590.155）、总操作时间（OR=0.888，95%CI：0.820~0.961）、胆道镜直视（OR=0.066，95%CI：0.005~0.795）为胆囊内引流失败的独立危险因素（P<0.05）。根据Logistic多因素回归分析独立影响因素，构建回归模型，模型公式ln[p/(1-p)]=3.938+3.459×胃改道术后-0.119×总操作时间-2.719×胆道镜直视。ROC曲线分析显示，回归模型具有一定预测价值，AUC为0.804，灵敏度为0.911，特异度为0.625。

结论

与常规ERCP下胆管引流联合体外胆囊穿刺或手术相比，ERCP下胆管引流联合胆囊内引流是治疗胆囊炎合并胆管炎的有效方法，操作简便、微创，并不增加术后不良事件。构建的疗效预测模型具有一定预测价值。

关键词: 胆囊炎, 胆管结石, 内镜逆行胰胆管造影术, 内引流, 胆道镜

Objective

To evaluate the efficacy and safety of endoscopic retrograde cholangiopancreatography (ERCP) plus biliary drainage combined with gallbladder drainage for acute cholecystitis complicated with cholangitis and to construct an efficacy prediction model.

Methods

Clinical data of 77 patients with acute cholecystitis complicated with cholangitis who received ERCP in Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine from September 2022 to April 2024 were retrospectively analyzed. The informed consents of all patients were obtained and the local ethical committee approval was received. Among them, 44 patients were male and 33 female, aged from 61 to 86 years, with a median age of 70 years. According to the success of ERCP gallbladder drainage, all patients were divided into the success and failure groups. In the success group, ERCP plus choledocholithotomy/biliary drainage+gallbladder drainage were adopted. In the failure group, choledocholithotomy/biliary drainage combined with percutaneous gallbladder puncture and drainage or cholecystectomy were performed in some patients. The success rate, clinical remission rate and postoperative adverse events in two groups were observed and recorded. The independent risk factors of failed gallbladder drainage were determined by multivariate Logistic regression analysis in some patients. The predictive value of regression model for successful gallbladder drainage was assessed by the receiver operating characteristic (ROC) curve.

Results

The clinical remission rate was 99%(76/77). Due to limited emergency operation conditions, the success rate of ERCP plus gallbladder drainage was 42%(32/77). The failure rate of gallbladder drainage was 58%(45/77). Among them, the symptoms of 12 cases were controlled by gallbladder puncture or emergency surgery, and 1 died of multiple organ failure. The remaining patients achieved clinical remission. No significant differences were found in the incidence and recurrence rate of adverse events between two groups (both P>0.05). Postoperatively, 5 patients developed hyperamylasemia, which were alleviated without special treatment. No bleeding or perforation occurred. In the success group, 1 patient experienced mild pancreatitis after surgery, which was mitigated after conservative medical treatment. 1 case developed postoperative pulmonary infection, which was improved after anti-infection treatment. At 6 months after ERCP, 6 cases had recurrent infection of the biliary system, including 5 in the failure group and 1 in the success group.Multivariate Logistic regression analysis showed that post-gastric bypass (OR=31.775, 95%CI: 1.711-590.155), the total operation time (OR=0.888, 95%CI: 0.820-0.961), direct vision under choledochoscope (OR=0.066,95%CI: 0.005-0.795) were the independent risk factors of failed gallbladder drainage (all P<0.05). According to multivariate Logistic regression analysis, the independent influencing factors were identified, and a regression model was constructed. The model formula was ln[p/(1-p)]=3.938+3.459×post-gastric bypass -0.119×total operation time -2.719×direct vision under choledochoscope. ROC curve analysis showed that the regression model had certain predictive value. The area under the ROC curve (AUC) was 0.804, the sensitivity was 0.911 and the specificity was 0.625, respectively.

Conclusions

Compared with conventional ERCP plus biliary drainage combined with gallbladder puncture or surgery, ERCP plus biliary drainage combined with gallbladder drainage is an effective treatment of cholecystitis complicated with cholangitis, which is simple and minimally invasive, and does not increase the incidence of postoperative adverse events. The logistic regression model yields certain predictive value for clinical efficacy.

Key words: Cholecystitis, Bile duct stones, Endoscopic retrograde cholangiopancreatography, Internal drainage, Choledochoscopy

表1 两组急性胆囊炎合并胆管炎患者基线资料比较

因素	内引流成功组	内引流失败组	统计值	P值
年龄(岁, $x ¯$ ±s)	71±12	69±18	t=0.517	0.607
性别(例, 男/女)	21/11	23/22	χ²=1.609	0.205
TB[μmol/L, M(Q₁, Q₃)]	152(92, 242)	93(39, 204)	Z=-1.685	0.092
ALT [U/L, M(Q₁, Q₃)]	91(34, 133)	101(27, 158)	Z=-0.444	0.657
WBC[×10⁹/L, M(Q₁, Q₃)]	5.2(2.7, 11.3)	10.4(3.8, 12.9)	Z=-1.101	0.271
中性粒细胞(%, $x ¯$ ±s)	77±10	78±8	t=-0.633	0.528
CRP[mg/L, M(Q₁, Q₃)]	40(21, 110)	83(30, 110)	Z=-0.486	0.627
Scr(μmol/L, $x ¯$ ±s)	99±50	102±63	t=-0.215	0.831
pro-BNP[pg/ml, M(Q₁, Q₃)]	454(203, 640)	542(188, 991)	Z=-1.034	0.301
胃改道术后（例）	1	10	χ²=4.120	0.042
感染性休克(例)	3	5	-	1.000
高血压(例)	27	39	χ²=0.000	1.000
糖尿病(例)	20	29	χ²=0.031	0.861
心脑血管疾病(例)	19	21	χ²=1.210	0.271
合并胰腺炎(例)	7	11	χ²=0.069	0.793

表1 两组急性胆囊炎合并胆管炎患者基线资料比较

因素	内引流成功组	内引流失败组	统计值	P值
年龄(岁, $x ¯$ ±s)	71±12	69±18	t=0.517	0.607
性别(例, 男/女)	21/11	23/22	χ²=1.609	0.205
TB[μmol/L, M(Q₁, Q₃)]	152(92, 242)	93(39, 204)	Z=-1.685	0.092
ALT [U/L, M(Q₁, Q₃)]	91(34, 133)	101(27, 158)	Z=-0.444	0.657
WBC[×10⁹/L, M(Q₁, Q₃)]	5.2(2.7, 11.3)	10.4(3.8, 12.9)	Z=-1.101	0.271
中性粒细胞(%, $x ¯$ ±s)	77±10	78±8	t=-0.633	0.528
CRP[mg/L, M(Q₁, Q₃)]	40(21, 110)	83(30, 110)	Z=-0.486	0.627
Scr(μmol/L, $x ¯$ ±s)	99±50	102±63	t=-0.215	0.831
pro-BNP[pg/ml, M(Q₁, Q₃)]	454(203, 640)	542(188, 991)	Z=-1.034	0.301
胃改道术后（例）	1	10	χ²=4.120	0.042
感染性休克(例)	3	5	-	1.000
高血压(例)	27	39	χ²=0.000	1.000
糖尿病(例)	20	29	χ²=0.031	0.861
心脑血管疾病(例)	19	21	χ²=1.210	0.271
合并胰腺炎(例)	7	11	χ²=0.069	0.793

表2 ERCP手术不良事件分析[例（%）]

因素	内引流成功组	内引流失败组	P值
高淀粉酶血症	2(6)	3(7)	>0.999^a
轻度胰腺炎	1(3)	0	0.416^a
中重度胰腺炎	0	0	/
出血	0	0	/
穿孔	0	0	/
其他	1(3)	1(2)	>0.999^a
胆系感染6个月内复发	1(3)	5(11)	0.391^a

表2 ERCP手术不良事件分析[例（%）]

因素	内引流成功组	内引流失败组	P值
高淀粉酶血症	2(6)	3(7)	>0.999^a
轻度胰腺炎	1(3)	0	0.416^a
中重度胰腺炎	0	0	/
出血	0	0	/
穿孔	0	0	/
其他	1(3)	1(2)	>0.999^a
胆系感染6个月内复发	1(3)	5(11)	0.391^a

表3 ERCP下胆囊内引流失败相关影响因素分析

因素	内引流成功组	内引流失败组	统计值	P值
总操作时间(min, $x ¯$ ±s)	35±10	27±8	t=3.469	0.001
胆管操作(例)			χ²=7.177	0.007
取石	10	28
单纯引流	22	17
超选胆囊方法(例)
切开刀	18	30	χ²=0.864	0.353
球囊联合切开刀	8	14	χ²=0.342	0.559
胆道镜直视	6	1	-	0.018
胃改道术后(例)	1	10	χ²=4.120	0.042
术后行胆囊穿刺外引流(例)	0	6	-	0.038
术后1周内胆囊手术(例)	0	6	-	0.038
住院期间胆系感染控制(例)	32	44	-	>0.999

表3 ERCP下胆囊内引流失败相关影响因素分析

因素	内引流成功组	内引流失败组	统计值	P值
总操作时间(min, $x ¯$ ±s)	35±10	27±8	t=3.469	0.001
胆管操作(例)			χ²=7.177	0.007
取石	10	28
单纯引流	22	17
超选胆囊方法(例)
切开刀	18	30	χ²=0.864	0.353
球囊联合切开刀	8	14	χ²=0.342	0.559
胆道镜直视	6	1	-	0.018
胃改道术后(例)	1	10	χ²=4.120	0.042
术后行胆囊穿刺外引流(例)	0	6	-	0.038
术后1周内胆囊手术(例)	0	6	-	0.038
住院期间胆系感染控制(例)	32	44	-	>0.999

表4 胆囊内引流失败影响因素的Logistic多因素回归分析

因素	b	SE(b)	Wald	P值	OR	95%CI
胃改道术后	3.459	1.491	5.383	0.020	31.775	1.711~590.155
总操作时间	-0.119	0.040	8.750	0.003	0.888	0.820~0.961
胆道镜直视	-2.719	1.270	4.583	0.032	0.066	0.005~0.795

表4 胆囊内引流失败影响因素的Logistic多因素回归分析

因素	b	SE(b)	Wald	P值	OR	95%CI
胃改道术后	3.459	1.491	5.383	0.020	31.775	1.711~590.155
总操作时间	-0.119	0.040	8.750	0.003	0.888	0.820~0.961
胆道镜直视	-2.719	1.270	4.583	0.032	0.066	0.005~0.795

图1 回归模型预测ERCP下胆囊内引流成功ROC曲线

图2 一例急性胆管炎、胆囊巨大结石、急性胆囊炎患者ERCP胆囊内引流成功术中注：a为ERCP乳头插管成功后先行EST，首先放置胰管支架（红色箭头）和胆管支架（蓝色箭头），解除壶腹部共同通道和胆管的梗阻；b为术中可见胆囊巨大高密度结石，X线下成功超选胆囊管，放置猪尾鼻胆囊管（白色箭头）行胆囊内引流；EST为内镜括约肌切开术

图3 一例急性胆管炎、急性胆囊炎患者ERCP下胆囊内引流失败术中注：a示ERCP导丝（①）进入胆囊，沿导丝进入9 Fr胆道镜（②），但难以继续通过进入胆囊；b示直视下见胆囊管水肿狭窄，仅能容纳导丝通过，考虑患者近期脑出血，继续操作风险较大而放弃胆囊内引流

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Clinical efficacy and construction of prediction model of ERCP plus biliary drainage combined with gallbladder drainage for acute cholecystitis complicated with cholangitis

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Clinical efficacy and construction of prediction model of ERCP plus biliary drainage combined with gallbladder drainage for acute cholecystitis complicated with cholangitis