改良胰管支架用于内镜逆行胰胆管造影取净胆总管结石后胆道引流的安全性及有效性分析

李佳林; 任笠坤; 冉勋; 夏绍萱; 周昱彤; 黄鑫; 韩民

doi:10.3969/j.issn.1001-5256.2023.08.021

改良胰管支架用于内镜逆行胰胆管造影取净胆总管结石后胆道引流的安全性及有效性分析

DOI: 10.3969/j.issn.1001-5256.2023.08.021

李佳林¹,
任笠坤¹,
冉勋^{1, 2},
夏绍萱¹,
周昱彤¹,
黄鑫¹,
韩民^{1, 2, , ,}

1.
贵州医科大学临床医学院，贵阳 550004
2.
贵州医科大学附属医院肝胆外科，贵阳 550004

伦理学声明：本研究方案经由贵州医科大学附属医院伦理委员会审批，批号：2023伦审第344号。ERCP前均获得每位患者及家属的书面知情同意。

利益冲突声明：本文不存在任何利益冲突。

作者贡献声明：李佳林负责课题设计，资料分析，撰写论文；任笠坤、冉勋、夏绍萱、周昱彤、黄鑫参与核查数据，修改论文；韩民负责拟定写作思路，指导撰写文章并最后定稿。

详细信息

通信作者:
韩民，409582096@qq.com (ORCID：0000-0001-7218-5276)

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出版历程
- 收稿日期: 2022-12-12
- 录用日期: 2023-02-07
- 出版日期: 2023-08-20

Safety and efficacy of modified pancreatic duct stent in biliary drainage after complete bile duct stone removal by endoscopic retrograde cholangiopancreatography

Jialin LI¹,
Likun REN¹,
Xun RAN^{1, 2},
Shaoxuan XIA¹,
Yutong ZHOU¹,
Xin HUANG¹,
Min HAN^{1, 2
, ,
,}

1.
College of Clinical Medicine, Guizhou Medical University, Guiyang 550004, China
2.
Department of Hepatobiliary Surgery, The Affiliated Hospital of Guizhou Medical University, Guiyang 550004, China

More Information

Corresponding author: HAN Min, 409582096@qq.com (ORCID: 0000-0001-7218-5276)

摘要

摘要: 目的探讨改良7Fr胰管塑料支架用于胆道内引流的临床应用价值。方法收集2021年4月—2022年6月在贵州医科大学附属医院肝胆外科行内镜逆行胰胆管造影(ERCP)取石后行胆道引流的121例胆总管结石患者的临床资料，根据术后胆道引流方式分为改良支架组(n=59)和鼻胆引流组(n=60)，其中改良支架组采用改良7Fr胰管塑料支架引流，鼻胆引流组采用鼻胆管引流，回顾性分析两组患者临床资料，观察改良支架组中支架自行脱落情况，比较两组临床疗效、患者术后舒适度及术后并发症发生率。符合正态分布的计量资料两组间比较采用成组t检验；非正态分布的计量资料两组间比较采用Mann－Whitney U检验；计数资料两组间比较采用χ²检验。结果两组结石清除率为100%。两组患者术后住院天数、总住院天数比较，差异均有统计学意义(t值分别为－3.997、2.317，P值均 < 0.05)。两组患者术后血清TBil、DBil、ALP、AST及GGT均较术前明显下降(P值均 < 0.05)。两组患者TBil、DBil、ALP、ALT、AST、GGT术前及术后比较，差异均无统计学意义(P值均>0.05)。改良支架组与鼻胆引流组术后－术前生化指标差值比较，差异均无统计学意义(P值均>0.05)。两组术后24 h内舒适度评分、术后首次进食、进饮时间比较，差异均有统计学意义(t值分别为2.001、3.579、4.604，P值均 < 0.05)。两组并发症比较，差异均无统计学意义(P值均>0.05)。改良支架组支架自行脱落率为83.05%，未发生支架阻塞、移位、断裂、穿孔及感染并发症。结论 ERCP取净胆总管结石后，应用改良7Fr胰管塑料支架行胆道内引流与鼻胆管引流效果相当，可缩短患者术后住院时长、提升患者术后舒适度，加速患者康复，且支架自行脱落率高，临床应用安全、有效。
- 胰胆管造影术，内窥镜逆行 /
- 引流术 /
- 支架
Abstract: Objective To investigate the clinical application value of modified 7Fr pancreatic duct plastic stent in biliary drainage. Methods Clinical data were collected from 121 patients with choledocholithiasis who underwent endoscopic retrograde cholangiopancreatography (ERCP) lithotomy and biliary drainage in Department of Hepatobiliary Surgery, The Affiliated Hospital of Guizhou Medical University, from April 2021 to June 2022, and according to the method for postoperative biliary drainage, they were divided into modified stent group with 59 patients and nasobiliary drainage group with 60 patients. The patients in the modified stent group received drainage with the modified 7Fr pancreatic duct plastic stent, and those in the nasobiliary drainage group received nasobiliary drainage. A retrospective analysis was performed for their clinical data, and stent dislodgement was observed for the modified stent group. The two groups were compared in terms of clinical outcome, postoperative comfort, and postoperative complications. The independent-samples t test was used for comparison of normally distributed continuous data between groups, and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between groups; the chi-square test was used for comparison of categorical data between groups. Results Both groups achieved a stone clearance rate of 100%. There were significant differences between the two groups in the length of postoperative hospital stay and the total length of hospital stay (t=-3.997 and 2.317, both P < 0.05). After treatment, both groups had significant reductions in total bilirubin (TBil), direct bilirubin (DBil), indirect bilirubin (IBil), alkaline phosphatase (ALP), aspartate aminotransferase (AST), and gamma-glutamyl transpeptidase (all P < 0.05), and there were no significant differences between the two groups in the changes in TBil, DBil, IBil, ALP, alanine aminotransferase, and AST after treatment (all P>0.05). Also, no significant differences were observed between the two groups in the changes in biochemical parameters after treatment (all P>0.05). There were significant differences between the two groups in comfort score within 24 hours after surgery and the time to first eating and drinking after surgery (t=2.001, 3.579, and 4.604, all P < 0.05). There were no significant differences in complications between the two groups (all P>0.05). In the modified stent group, the rate of spontaneous stent dislodgement was 83.05%, and there were no complications such as stent occlusion, displacement, rupture, perforation, and infection. Conclusion After complete bile duct stone removal by ERCP, biliary drainage using the modified 7Fr pancreatic duct plastic stent has a similar effect to nasobiliary drainage and can shorten the length of postoperative hospital stay, improve postoperative comfort, and accelerate postoperative recovery, with a relatively high spontaneous dislodgement rate. Therefore, it is safe and effective in clinical practice.
- Cholangiopancreatography, Endoscopic Retrograde /
- Drainage /
- Stents

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图 1 经人工改良去除胰管塑料支架(7Fr、5 cm)

注：红色箭头所示为侧翼锚定结构。

Figure 1. Remove the side wing anchor structure of the plastic stent (7Fr, 5 cm)

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图 2 支架组成功置入改良胰管支架

Figure 2. The plastic stent of the modified pancreatic duct was successfully placed

下载: 全尺寸图片幻灯片

图 3 改良支架组某患者支架脱落前后腹部立位平片对比

注：a，出院后第1周复查支架在位(红色箭头所示)；b，出院后第2周再次复查提示支架已脱落(红色箭头所示)。

Figure 3. Comparison of abdominal X-ray of a patient in the modified stent group before and after stent spontaneous dislodgement

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表 1 改良支架组与鼻胆引流组一般资料情况比较

Table 1. Comparison of general information between modified stent group and nasobiliary drainage group

项目	改良支架组(n=59)	鼻胆引流组(n=60)	统计值	P值
男/女(例)	28/31	31/29	χ²=0.211	0.646
年龄(岁)	54.6±15.6	59.2±19.0	t=1.431	0.155
总住院天数(d)	9.0±4.4	11.0±5.3	t=2.317	0.022
术后住院天数(d)	3(2 ~ 5)	7(3~15)	Z=-3.997	< 0.001
既往胆囊切除(例)	38	41	χ²=0.206	0.650
胆总管直径(cm)	1.1±0.5	1.2±0.5	t=1.269	0.207
胆总管扩张直径>8 mm(例)	33	41	χ²=1.945	0.163
结石直径(cm)	0.8±0.4	0.9±0.4	t=1.334	0.185
胆总管结石数目(例)			χ²=5.391	0.145
1枚	38	28
2枚	5	6
3枚	3	2
多枚	13	24
ASA分级(例)			χ²=4.379	0.112
Ⅰ级	22	12
Ⅱ级	28	37
Ⅲ级	9	11
手术时长(min)	61.2±9.0	60.8±5.4	t=-0.354	0.724
结石清除率(%)	100	100	-	-
EST(例)	59	60	-	-
EPBD(例)	27	35	χ²=1.884	0.170

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表 2 术前及术后24 h生化指标组内比较情况

Table 2. Comparison of biochemical indexes before and 24 hours after operation between the modified stent group and the nasobiliary drainage group

指标	改良支架组(n=59)
指标	术前	术后	Z值	P值
TBil(μmol/L)	22.7(11.4~84.1)	17.7(12.1~34.2)	-2.271	0.023
DBil(μmol/L)	12.5(4.7~62.1)	8.3(5.0~22.0)	-1.992	0.046
ALP(U/L)	183.0(108.0~312.0)	120.0(83.0~238.0)	-2.027	0.043
ALT(U/L)	78.8(34.8~225.9)	51.4(32.7~88.9)	-2.371	0.018
AST(U/L)	53.1(21.8~111.3)	32.9(22.3~51.1)	-2.247	0.025
GGT(U/L)	301.2(118.3~451.9)	185.0(174.9~542.3)	-1.994	0.046

指标	鼻胆引流组(n=60)
指标	术前	术后	Z值	P值
TBil(μmol/L)	30.2(15.4~66.0)	16.3(10.9~25.4)	-3.567	< 0.001
DBil(μmol/L)	18.3(7.6~46.7)	7.7(5.0~14.6)	-3.176	0.001
ALP(U/L)	187.0(111.5~314.25)	120.5(90.0~232.0)	-2.590	0.010
ALT(U/L)	129.6(42.0~271.3)	48.6(23.4~134.5)	-3.176	0.001
AST(U/L)	63.7(33.7~172.6)	32.0(20.4~49.7)	-4.475	< 0.001
GGT(U/L)	361.9(174.9~542.3)	165.5(87.5~340.7)	-3.217	0.001

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表 3 改良支架组与鼻胆引流组术后-术前生化指标差值比较

Table 3. Comparison of difference of biochemical indexes between modified stent group and naso-biliary drainage group

指标	改良支架组(n=59)	鼻胆引流组(n=60)	统计值	P值
TBil(μmol/L)	-22.1±50.5	-22.7±34.3	t=-0.077	0.938
DBil(μmol/L)	-2.6(-41.1~0.2)	-7.2(-23.4~-0.6)	Z=-0.699	0.485
ALP(U/L)	-38.0(-98.0~-18.0)	-52.5(-101.5~-21.3)	Z=-0.827	0.408
ALT(U/L)	21.0(-2.5~107.9)	65.4(4.2~136.5)	Z=-1.470	0.142
AST(U/L)	11.1(-2.3~63.3)	37.5(1.8~147.9)	Z=-1.618	0.106
GGT(U/L)	-156.8±267.2	-178.2±260.1	t=-0.443	0.659

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表 4 改良支架组与鼻胆引流组术后情况比较

Table 4. Comparison of general situation after operation between modified stent group and nasobiliary drainage group

项目	改良支架组(n=59)	鼻胆引流组(n=60)	统计值	P值
24 h VAS评分(分)	2.1±1.2	6.2±1.7	t=2.001	0.048
首次进食时间(h)	27.6±12.6	34.3±7.0	t=3.579	0.001
首次进饮时间(h)	7.1±2.3	10.2±4.7	t=4.604	< 0.001
术后恶心呕吐(例)	4	6	χ²=0.188	0.665

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表 5 改良支架组与鼻胆引流组术后并发症比较

Table 5. Comparison of postoperative complications between modified stent group and nasobiliary drainage group

项目	改良支架组(n=59)	鼻胆引流组(n=60)	χ²值	P值
总并发症(例)	13	20	1.895	0.169
PEP(例)	1	0	1.026	0.311
高淀粉酶血症(例)	12	17	1.032	0.310
出血(例)	0	3	1.368	0.242

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参考文献(35)

[1]	MUKAI S, ITOI T, BARON TH, et al. Indications and techniques of biliary drainage for acute cholangitis in updated Tokyo Guidelines 2018[J]. J Hepatobiliary Pancreat Sci, 2017, 24(10): 537-549. doi: 10.1002/jhbp.496.
[2]	LIN Y, LIN XY, CHEN R, et al. Application of ERCP in treatment of common bile duct stones after cholecystectomy[J/OL]. Chin J Hepat Surg(Electronic Edition), 2021, 10(5): 502-505. DOI: 10.3877/cma.j.issn.2095-3232.2021.05.015. 林颖, 林显艺, 陈荣, 等. ERCP在胆囊切除术后胆总管结石治疗中的应用[J/OL]. 中华肝脏外科手术学电子杂志, 2021, 10(5): 502-505. DOI: 10.3877/cma.j.issn.2095-3232.2021.05.015.
[3]	DONG WF, PANG EJ, DAI ZL. Clinical efficacy of ERCP combined with LC in treatment of patients with cholecystolithiasis combined with choledocholithiasis and influencing factors for recurrence of choledocholithiasis after surgery[J]. Clin Misdiagn Misther, 2021, 34(5): 85-90. DOI: 10.3969/j.issn.1002-3429.2021.05.017. 董维峰, 庞尔君, 代镇岭. ERCP联合LC治疗胆囊结石合并胆总管结石临床效果及术后胆总管结石复发影响因素分析[J]. 临床误诊误治, 2021, 34(5): 85-90. DOI: 10.3969/j.issn.1002-3429.2021.05.017.
[4]	DUMONCEAU JM, TRINGALI A, BLERO D, et al. Endoscopic biliary stenting: indications, choice of stents, and results: European Society of Gastrointestinal Endoscopy (ESGE) clinical guideline-updated october 2017[J]. Endoscopy, 2018, 50(9): 910-930. DOI: 10.1055/a-0659-9864.
[5]	CHENG J, LI QL, XU MD, et al. Clinical value of using pancreatic duct stent for bile duct drainage after endoscopic removal of common bile duct stones[J]. Chin J Dig Endosc, 2019, 36(9): 686-688. DOI: 10.3760/cma.j.issn.1007-5232.2019.09.015. 成婧, 李全林, 徐美东, 等. 内镜取净胆总管结石后应用胰管支架行胆管引流的临床价值[J]. 中华消化内镜杂志, 2019, 36(9): 686-688. DOI: 10.3760/cma.j.issn.1007-5232.2019.09.015.
[6]	HE QB, WANG L, PENG CY, et al. Modified prophylactic 5-fr pancreatic duct stent enhances the rate of spontaneous dislodgement: A multicenter randomized controlled trial[J]. United European Gastroenterol J, 2018, 6(10): 1519-1526. DOI: 10.1177/2050640618804729.
[7]	LEE JK, LEE SH, KANG BK, et al. Is it necessary to insert a nasobiliary drainage tube routinely after endoscopic clearance of the common bile duct in patients with choledocholithiasis-induced cholangitis? A prospective, randomized trial[J]. Gastrointest Endosc, 2010, 71(1): 105-110. DOI: 10.1016/j.gie.2009.08.009.
[8]	BANKS PA, BOLLEN TL, DERVENIS C, et al. Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis-2012: revision of the Atlanta classification and definitions by international consensus[J]. Gut, 2013, 62(1): 102-111. DOI: 10.1136/gutjnl-2012-302779.
[9]	BALTHAZAR EJ, ROBINSON DL, MEGIBOW AJ, et al. Acute pancreatitis: value of CT in establishing prognosis[J]. Radiology, 1990, 174(2): 331-336. DOI: 10.1148/radiology.174.2.2296641.
[10]	COTTON PB, EISEN GM, AABAKKEN L, et al. A lexicon for endoscopic adverse events: report of an ASGE workshop[J]. Gastrointest Endosc, 2010, 71(3): 446-454. DOI: 10.1016/j.gie.2009.10.027.
[11]	PARK SY, PARK CH, CHO SB, et al. The safety and effectiveness of endoscopic biliary decompression by plastic stent placement in acute suppurative cholangitis compared with nasobiliary drainage[J]. Gastrointest Endosc, 2008, 68(6): 1076-1080. DOI: 10.1016/j.gie.2008.04.025.
[12]	LEE DW, CHAN AC, LAM YH, et al. Biliary decompression by nasobiliary catheter or biliary stent in acute suppurative cholangitis: a prospective randomized trial[J]. Gastrointest Endosc, 2002, 56(3): 361-365. DOI: 10.1016/s0016-5107(02)70039-4.
[13]	OTANI K, UEKI T, MATSUMURA K, et al. Comparison between endoscopic biliary stenting and nasobiliary drainage in patients with acute cholangitis due to choledocholithiasis: is endoscopic biliary stenting useful?[J]. Hepatogastroenterology, 2015, 62(139): 558-563.
[14]	SHARMA BC, KUMAR R, AGARWAL N, et al. Endoscopic biliary drainage by nasobiliary drain or by stent placement in patients with acute cholangitis[J]. Endoscopy, 2005, 37(5): 439-443. DOI: 10.1055/s-2005-861054.
[15]	PERRI V, FAMILIARI P, TRINGALI A, et al. Plastic biliary stents for benign biliary diseases[J]. Gastrointest Endosc Clin N Am, 2011, 21(3): 405-433, viii. DOI: 10.1016/j.giec.2011.04.012.
[16]	GROMSKI MA, BICK BL, VEGA D, et al. A rare complication of ERCP: duodenal perforation due to biliary stent migration[J]. Endosc Int Open, 2020, 8(11): E1530-E1536. DOI: 10.1055/a-1231-4758.
[17]	MANES G, PASPATIS G, AABAKKEN L, et al. Endoscopic management of common bile duct stones: European Society of Gastrointestinal Endoscopy (ESGE) guideline[J]. Endoscopy, 2019, 51(5): 472-491. DOI: 10.1055/a-0862-0346.
[18]	RASHDAN A, FOGEL EL, MCHENRYL Jr, et al. Improved stent characteristics for prophylaxis of post-ERCP pancreatitis[J]. Clin Gastroenterol Hepatol, 2004, 2(4): 322-329. DOI: 10.1016/s1542-3565(04)00062-x.
[19]	TSUCHAYA T, ITOI T, SOFULI A, et al. Temporary pancreatic stent to prevent post endoscopic retrograde cholangiopancreatography pancreatitis: a preliminary, single-center, randomized controlled trial[J]. J Hepatobiliary Pancreat Surg, 2007, 14(3): 302-307. DOI: 10.1007/s00534-006-1147-8.
[20]	KAWASHIMA H, ITOH A, OHNO E, et al. Is nasobiliary drainage unnecessary for drainage of acute suppurative cholangitis? Our experience[J]. Dig Endosc, 2010, 22(Suppl 1): S118-S122. DOI: 10.1111/j.1443-1661.2010.00959.x.
[21]	CHRISTOFORIDIS E, GOULIMARIS I, KANELLOS I, et al. Post-ERCP pancreatitis and hyperamylasemia: patient-related and operative risk factors[J]. Endoscopy, 2002, 34(4): 286-292. DOI: 10.1055/s-2002-23630.
[22]	ANDRIULLI A, CLEMENTE R, SOLMI L, et al. Gabexate or somatostatin administration before ERCP in patients at high risk for post-ERCP pancreatitis: a multicenter, placebo-controlled, randomized clinical trial[J]. Gastrointest Endosc, 2002, 56(4): 488-495. DOI: 10.1067/mge.2002.128130.
[23]	FREEMAN ML, GUDA NM. Prevention of post-ERCP pancreatitis: a comprehensive review[J]. Gastrointest Endosc, 2004, 59(7): 845-864. DOI: 10.1016/s0016-5107(04)00353-0.
[24]	HE QB, XU T, WANG J, et al. Risk factors for post-ERCP pancreatitis and hyperamylasemia: A retrospective single-center study[J]. J Dig Dis, 2015, 16(8): 471-478. DOI: 10.1111/1751-2980.12258.
[25]	COTTON PB, GARROW DA, GALLAGHER J, et al. Risk factors for complications after ERCP: a multivariate analysis of 11, 497 procedures over 12 years[J]. Gastrointest Endosc, 2009, 70(1): 80-88. DOI: 10.1016/j.gie.2008.10.039.
[26]	BAE SS, LEE DW, HAN J, et al. Risk factor of bleeding after endoscopic sphincterotomy in average risk patients[J]. Surg Endosc, 2019, 33(10): 3334-3340. DOI: 10.1007/s00464-018-06623-8.
[27]	BAJBOUJ M, TREIBER M, LUDWIG L, et al. Forgotten biliary endoprosthesis. "Follow up" after 10 years[J]. Endoscopy, 2008, 40 Suppl 2: E221. DOI: 10.1055/s-2008-1077431.
[28]	LAWRNCE C, ROMAGNUOLO J, PAYNE KM, et al. Low symptomatic premature stent occlusion of multiple plastic stents for benign biliary strictures: comparing standard and prolonged stent change intervals[J]. Gastrointest Endosc, 2010, 72(3): 558-563. DOI: 10.1016/j.gie.2010.05.029.
[29]	LUBBERT C, WENDT K, FEISTHAMMEL J, et al. Epidemiology and resistance patterns of bacterial and fungal colonization of biliary plastic stents: a prospective cohort study[J]. PLoS One, 2016, 11(5): e0155479. DOI: 10.1371/journal.pone.0155479.
[30]	PISELLO F, GERACI G, LI VOLSI F, et al. Permanent stenting in "unextractable" common bile duct stones in high risk patients. A prospective randomized study comparing two different stents[J]. Langenbecks Arch Surg, 2008, 393(6): 857-863. DOI: 10.1007/s00423-008-0388-1.
[31]	SOFUNI A, MAGUCHI H, ITOI T, et al. Prophylaxis of post-endoscopic retrograde cholangiopancreatography pancreatitis by an endoscopic pancreatic spontaneous dislodgement stent[J]. Clin Gastroenterol Hepatol, 2007, 5(11): 1339-1346. DOI: 10.1016/j.cgh.2007.07.008.
[32]	NISHIWAKI M, MIZUNO C, YANO K, et al. Retroperitoneal perforation caused by migration of a pancreatic spontaneous dislodgement stent into periampullary diverticula[J]. Intern Med, 2018, 57(3): 351-355. DOI: 10.2169/internalmedicine.9054-17.
[33]	KEHLET H, SLIM K. The future of fast-track surgery[J]. Br J Surg, 2012, 99(8): 1025-1026. DOI: 10.1002/bjs.8832.
[34]	Chinese Research Hospital Association, Society for Hepatopancreatobiliary Surgery. Expert consensus on enhanced recovery after hepatobiliary & pancreatic surgery(2015 edition)[J]. J Clin Hepatol, 2016, 32(6): 1040-1045. DOI: 10.3969/j.issn.1001-5256.2016.06.004. 中国研究型医院学会肝胆胰外科专业委员会. 肝胆胰外科术后加速康复专家共识(2015版)[J]. 临床肝胆病杂志, 2016, 32(6): 1040-1045. DOI: 10.3969/j.issn.1001-5256.2016.06.004.
[35]	VARADHAN KK, NEAL KR, DEJONG CH, et al. The enhanced recovery after surgery (ERAS) pathway for patients undergoing major elective open colorectal surgery: a meta-analysis of randomized controlled trials[J]. Clin Nutr, 2010, 29(4): 434-440. DOI: 10.1016/j.clnu.2010.01.004.