胆胰成像系统在胆总管结石ERCP取石中的应用价值

doi:10.3877/cma.j.issn.2095-3232.2026.04.012

目的

探讨胆胰成像系统在胆总管结石患者ERCP取石中的应用价值。

方法

回顾性分析2024年1月至12月中山大学附属第三医院收治的70例胆总管结石患者临床资料。患者均签署知情同意书，符合医学伦理学规定。其中男45例，女25例；年龄25~88岁，中位年龄57岁。据手术方式将患者分为ERCP取石组（ERCP组）和eyeMax洞察胆胰成像系统辅助ERCP取石组（eyeMax组），每组35例。两组术后并发症、结石总体清除率等比较采用χ²检验或Fisher确切概率法；操作时间、累积辐射剂量空气比释动能（AK）、住院费用等比较采用t检验。

结果

eyeMax组取石操作时间和辐射剂量累积AK值分别为（82±36） min、（111±56）mGy，均明显高于ERCP组的（36±15） min、（55±31）mGy（t=6.903，5.169；P<0.001）。eyeMax组住院费用为（3.5±0.7）万元，亦明显高于ERCP组的（2.6±0.5）万元（t=6.136，P<0.001）。两组均顺利完成操作，eyeMax组和ERCP组困难插管率分别为14%（5/35）、23%（8/35），差异无统计学意义（χ²=0.850，P=0.356）。eyeMax组和ERCP组结石总体清除率分别为97%（34/35）、86%（30/35），差异无统计学意义（P=0.198）；而亚组分析显示，eyeMax组的多发结石残留率为4%（1/23），明显低于ERCP组的31%（5/16）（P=0.033）。eyeMax组和ERCP组胆总管结石复发率分别为9%（5/35）、14%（3/35），两组比较差异无统计学意义（P=0.710）。两组均无穿孔、重症胰腺炎等严重并发症。eyeMax组术后轻度胰腺炎、高淀粉酶血症、胆管炎、出血分别为4、3、3、1例，ERCP组相应为3、2、4、0例，差异无统计学意义（P>0.05）。

结论

胆胰成像系统辅助ERCP取石可提高胆总管结石多发结石清除率，该系统使ERCP取石操作可视化、精准化，且不增加严重并发症风险，但需关注辐射暴露、设备成本及技术门槛问题。

关键词: 胆总管结石, eyeMax胆胰成像系统, 内镜逆行胰胆管造影术

Objective

To evaluate the application of cholangiopancreatography system in endoscopic retrograde cholangiopancreatography (ERCP) for patients with common bile duct stones.

Methods

Clinical data of 70 patients with common bile duct stones admitted to the Third Affiliated Hospital of Sun Yat-sen University from January to December 2024 were analyzed retrospectively. The informed consents of all patients were obtained and the local ethical committee approval was received. Among them, 45 patients were male and 25 female, aged from 25 to 88 years, with a median age of 57 years. All patients were divided into the ERCP group (ERCP group, n=35) and eyeMax cholangiopancreatography system-assisted ERCP group (eyeMax group, n=35). The incidence of postoperative complications and overall stone removal rate between two groups were compared by Chi-square test or Fisher's exact test. Operation time, cumulative radiation dose, air kerma (AK) and hospitalization expenses were compared by t-test.

Results

The operation time and cumulative AK of radiation dose in the eyeMax group were (82±36) min and (111±56) mGy, significantly higher than (36±15) min and (55±31) mGy in the ERCP group (t=6.903, 5.169; both P<0.001). The hospitalization expense in the eyeMax group was (3.5±0.7)×10⁴ yuan, significantly higher than (2.6±0.5)×10⁴ yuan in the ERCP group (t=6.136, P<0.001). The procedures were successfully completed in two groups. The difficult intubation rates in the eyeMax and ERCP groups were 14%(5/35) and 23%(8/35), with no statistical significance (χ²=0.850, P=0.356). The overall stone removal rates in the eyeMax and ERCP groups were 97%(34/35) and 86%(30/35), with no statistical significance (P=0.198). Subgroup analysis showed that the residual rate of multiple stones in the eyeMax group was 4%(1/23), significantly lower than 31%(5/16) in the ERCP group (P=0.033). The recurrence rates of common bile duct stones in the eyeMax and ERCP groups were 9%(5/35) and 14%(3/35), with no statistical significance (P=0.710). No severe complications such as perforation and severe pancreatitis occurred in two groups. In the eyeMax group, 4 patients developed mild pancreatitis, 3 cases of hyperamylasemia, 3 cases of cholangitis and 1 case of hemorrhage, and 3,2,4 and 0 in the ERCP group, with no statistical significance (all P>0.05).

Conclusions

The cholangiopancreatography system-assisted ERCP can improve the removal rate of multiple common bile duct stones. This system enhances the visualization and precision of ERCP procedures without increasing the risk of severe complications. However, extensive attention should be paid to the radiation exposure, equipment cost and technical issues.

Key words: Common bile duct stones, EyeMax biliary and pancreatic imaging system, Endoscopic retrograde cholangiopancreatography(ERCP)

图1 一例胆总管结石患者ERCP取石术中注：a为ERCP术插管导丝进入胆总管；b为ERCP造影示胆总管多发结石；c为十二指肠乳头球囊扩张乳头括约肌；d、e为取石球囊取石；f为取石球囊堵塞造影示胆总管结石取净

图2 一例胆总管结石患者eyeMax洞察胆胰成像系统辅助ERCP取石注：a为eyeMax洞察胆胰成像系统进入胆总管，探查发现结石逃逸于肝内胆管分支；b、c为直视下应用取石网篮取石

表1 两组胆总管结石患者基线资料比较

指标	eyeMax组	ERCP组	统计值	P值
性别(例, 男/女)	22/13	23/12	χ²=0.062	0.803
年龄(岁, $x ¯$ ±s)	60±15	55±14	t=1.253	0.214
合并高血压(例)	7	5	χ²=0.402	0.526
合并糖尿病(例)	8	4	χ²=1.609	0.205
合并胆囊结石(例)	16	20	χ²=0.915	0.339
WBC(×10⁹/L, $x ¯$ ±s)	7.2±3.6	6.8±2.4	t=0.446	0.657
Hb(g/L, $x ¯$ ±s)	115±18	127±23	t=-2.447	0.017
Plt(×10⁹/L, $x ¯$ ±s)	243±86	217±85	t=1.300	0.198
ALT [U/L, M(Q₁, Q₃)]	52(35, 139)	76(27, 113)	Z=-0.024	0.981
AST [U/L, M(Q₁, Q₃)]	47(34, 81)	49(25, 114)	Z=-0.476	0.634
TB [μmol/L, M(Q₁, Q₃)]	33(12, 89)	29(18, 104)	Z=0.241	0.810
DB [μmol/L, M(Q₁, Q₃)]	17(4, 55)	17(6, 67)	Z=-0.317	0.751
胆总管直径(mm, $x ¯$ ±s)	10±4	9±3	t=1.128	0.263
结石最大直径(mm, $x ¯$ ±s)	10±6	8±4	t=1.569	0.121
单发结石(例)	12	19	χ²=2.837	0.092

表1 两组胆总管结石患者基线资料比较

指标	eyeMax组	ERCP组	统计值	P值
性别(例, 男/女)	22/13	23/12	χ²=0.062	0.803
年龄(岁, $x ¯$ ±s)	60±15	55±14	t=1.253	0.214
合并高血压(例)	7	5	χ²=0.402	0.526
合并糖尿病(例)	8	4	χ²=1.609	0.205
合并胆囊结石(例)	16	20	χ²=0.915	0.339
WBC(×10⁹/L, $x ¯$ ±s)	7.2±3.6	6.8±2.4	t=0.446	0.657
Hb(g/L, $x ¯$ ±s)	115±18	127±23	t=-2.447	0.017
Plt(×10⁹/L, $x ¯$ ±s)	243±86	217±85	t=1.300	0.198
ALT [U/L, M(Q₁, Q₃)]	52(35, 139)	76(27, 113)	Z=-0.024	0.981
AST [U/L, M(Q₁, Q₃)]	47(34, 81)	49(25, 114)	Z=-0.476	0.634
TB [μmol/L, M(Q₁, Q₃)]	33(12, 89)	29(18, 104)	Z=0.241	0.810
DB [μmol/L, M(Q₁, Q₃)]	17(4, 55)	17(6, 67)	Z=-0.317	0.751
胆总管直径(mm, $x ¯$ ±s)	10±4	9±3	t=1.128	0.263
结石最大直径(mm, $x ¯$ ±s)	10±6	8±4	t=1.569	0.121
单发结石(例)	12	19	χ²=2.837	0.092

表2 两组胆总管结石患者采用ERCP取石治疗疗效比较

指标	eyeMax组	ERCP组	统计值	P值
操作成功 [例(%)]	35(100)	35(100)	/	/
困难插管 [例(%)]	5(14)	8(23)	χ²=0.850	0.356
结石清除 [例(%)]	34(97)	30(86)	-	0.198
多发结石残留 [例(%)]	1(4)	5 (31)	-	0.033
结石复发[例(%)]	5(14)	3(9)	-	0.710
取石操作时间(min, $x ¯$ ±s)	82±36	36±15	t=6.903	<0.001
累积AK值(mGy, $x ¯$ ±s)	111±56	55±31	t=5.169	<0.001
住院时间(d, $x ¯$ ±s)	7.3±2.9	6.5±1.9	t=1.379	0.173
住院费用(万元, $x ¯$ ±s)	3.5±0.7	2.6±0.5	t=6.136	<0.001
结石残留二次手术（例）	0	5	/	/
再次手术住院费用[万元, M(Q₁, Q₃)]	0	2.6(1.6, 3.5)	/	/

表2 两组胆总管结石患者采用ERCP取石治疗疗效比较

指标	eyeMax组	ERCP组	统计值	P值
操作成功 [例(%)]	35(100)	35(100)	/	/
困难插管 [例(%)]	5(14)	8(23)	χ²=0.850	0.356
结石清除 [例(%)]	34(97)	30(86)	-	0.198
多发结石残留 [例(%)]	1(4)	5 (31)	-	0.033
结石复发[例(%)]	5(14)	3(9)	-	0.710
取石操作时间(min, $x ¯$ ±s)	82±36	36±15	t=6.903	<0.001
累积AK值(mGy, $x ¯$ ±s)	111±56	55±31	t=5.169	<0.001
住院时间(d, $x ¯$ ±s)	7.3±2.9	6.5±1.9	t=1.379	0.173
住院费用(万元, $x ¯$ ±s)	3.5±0.7	2.6±0.5	t=6.136	<0.001
结石残留二次手术（例）	0	5	/	/
再次手术住院费用[万元, M(Q₁, Q₃)]	0	2.6(1.6, 3.5)	/	/

表3 两组术后并发症比较[例（%）]

组别	例数	轻度胰腺炎	高淀粉酶血症	胆管炎	出血
eyeMax组	35	4(11)	3(9)	3(9)	1(3)
ERCP组	35	3(9)	2(6)	4(11)	0
P值^a		>0.999	>0.999	>0.999	>0.999

表3 两组术后并发症比较[例（%）]

组别	例数	轻度胰腺炎	高淀粉酶血症	胆管炎	出血
eyeMax组	35	4(11)	3(9)	3(9)	1(3)
ERCP组	35	3(9)	2(6)	4(11)	0
P值^a		>0.999	>0.999	>0.999	>0.999

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Application value of cholangiopancreatography system in ERCP for common bile duct stone removal

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Application value of cholangiopancreatography system in ERCP for common bile duct stone removal