一期缝合与T管引流治疗复发性胆总管结石的效果及安全性分析

任敏强 ,  王万超 ,  崔树青 ,  孟晓东 ,  刘四清

临床肝胆病杂志 ›› 2026, Vol. 42 ›› Issue (7) : 1648 -1655.

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临床肝胆病杂志 ›› 2026, Vol. 42 ›› Issue (7) : 1648 -1655. DOI: 10.12449/JCH260722
胆道疾病

一期缝合与T管引流治疗复发性胆总管结石的效果及安全性分析

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Efficacy and safety of primary duct closure versus T-tube drainage in treatment of recurrent choledocholithiasis

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摘要

目的 为复发性胆总管结石(RCL)患者行腹腔镜胆总管探查术(LCBDE)后合理选择胆总管闭合方式提供临床参考依据。 方法 回顾性分析2022年2月—2025年12月华北理工大学附属医院肝胆胰外科收治的121例行LCBDE治疗RCL患者的临床资料。根据胆总管闭合方式的不同,将患者分为一期缝合组(PDC组,n=58)和T管引流组(TTD组,n=63)。比较两组患者的手术时间、术后第1天引流量、术后第3天总胆红素水平、术后恢复进食时间、术后拔除引流管时间、术后1周胆总管直径、术后住院时间、住院总费用及并发症情况,并分析术后并发症的危险因素。计量资料两组间比较采用成组t检验或Mann-Whitney U检验,计数资料两组间比较采用χ²检验或Fisher精确检验。采用多因素Logistic回归分析术后并发症的影响因素。 结果 PDC组的手术时间[48.50(39.00~59.25)min vs 55.00(46.00~69.00)min,Z=-2.726,P=0.006]、术后第3天总胆红素水平[17.25(14.43~21.30)μmol/L vs 20.06(16.40~29.30)μmol/L,Z=-2.950,P=0.003]、术后恢复进食时间[1(1~1)d vs 1(1~2)d,Z=-4.506,P<0.001]、术后拔除引流管时间[7(7~7)d vs 8(8~9)d,Z=-9.693,P<0.001]、术后住院时间[8(8~8)d vs 10(9~11)d,Z=-8.960,P<0.001]、住院总费用[21 750(20 369~23 310)元vs 24 889(23 438~26 920)元,Z=-5.572,P<0.001]均显著低于TTD组,PDC组的术后1周胆总管直径[1.0(0.9~1.1)cm vs 1.0(1.0~1.1)cm,Z=-2.064,P=0.039]较TTD组更接近正常胆道生理解剖结构。PDC组总并发症发生率(10.34% vs 26.98%,P=0.024)、电解质紊乱发生率(1.72% vs 15.87%,P=0.006)均显著低于TTD组。多因素Logistic回归分析显示,术前胆总管直径<1.3 cm、术前总胆红素水平≥21.0 μmol/L是患者出现术后并发症的独立危险因素,而一期缝合术式为术后并发症的独立保护因素(P值均<0.05)。 结论 在严格把握适应证的前提下,RCL患者行LCBDE后采用PDC可加快康复、降低并发症与住院成本,临床应用更具优势。

Abstract

Objective To provide a clinical reference for rational selection of the methods for common bile duct closure after laparoscopic common bile duct exploration (LCBDE) in patients with recurrent choledocholithiasis (RCL). Methods A retrospective analysis was performed for the clinical data of 121 patients with RCL who underwent LCBDE in the Department of Hepatopancreatobiliary Surgery, The Affiliated Hospital of North China University of Science and Technology, from February 2022 to December 2025, and according to the method for common bile duct closure, the patients were divided into primary duct closure group (PDC group with 58 patients) and T-tube drainage group (TTD group with 63 patients). The two groups were compared in terms of time of operation, drainage volume on day 1 after surgery, total bilirubin level on day 3 after surgery, time to diet after surgery, time to drainage tube removal after surgery, common bile duct diameter at 1 week after surgery, length of postoperative hospital stay, total hospitalization costs, and complications, and the risk factors for postoperative complications were analyzed. The independent-samples t test or the Mann-Whitney U test was used for comparison of continuous data between groups, and the chi-square test or the Fisher’s exact test was used for comparison of categorical data between groups. The multivariate Logistic regression analysis was used to identify influencing factors for postoperative complications. Results Compared with the TTD group, the PDC group had a significantly shorter time of operation [48.50 (39.00 — 59.25) min vs 55.00 (46.00 — 69.00) min, Z=-2.726, P=0.006], a significantly lower level of total bilirubin on day 3 after surgery [17.25 (14.43 — 21.30) μmol/L vs 20.06 (16.40 — 29.30) μmol/L, Z=-2.950, P=0.003], a significantly shorter time to diet after surgery [1 (1 — 1) d vs 1 (1 — 2) d, Z=-4.506, P<0.001], a significantly shorter time to drainage tube removal after surgery [7 (7 — 7) d vs 8 (8 — 9) d, Z=-9.693, P<0.001], a significantly shorter length of postoperative hospital stay [8 (8 — 8) d vs 10 (9 — 11) d, Z=-8.960, P<0.001], and significantly lower total hospitalization costs [21 750 (20 369 — 23 310) yuan vs 24 889 (23 438 — 26 920) yuan, Z=-5.572, P<0.001], and common bile duct diameter at 1 week after surgery in the PDC group was closer to the normal physiological anatomical structure of the biliary tract compared with that in the TTD group [1.0 (0.9 — 1.1) cm vs 1.0 (1.0 — 1.1) cm, Z=-2.064, P=0.039]. Compared with the TTD group, the PDC group had significantly lower incidence rates of total complications (10.34% vs 26.98%, P=0.024) and electrolyte disturbance (1.72% vs 15.87%, P=0.006). The multivariate logistic regression analysis showed that common bile duct diameter <1.3 cm before surgery and total bilirubin level ≥21.0 μmol/L before surgery were independent risk factors for postoperative complications, while primary duct closure was an independent protective factor against postoperative complications (P<0.05). Conclusion Under the premise of strict control of indications, PDC after LCBDE for RCL patients can accelerate recovery and reduce complications and hospitalization costs, thereby demonstrating greater advantages in clinical application.

关键词

胆总管结石病 / 一期缝合 / T管引流 / 治疗学

Key words

Choledocholithiasis / Primary Duct Closure / T-Tube Drainage / Therapeutics

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任敏强,王万超,崔树青,孟晓东,刘四清. 一期缝合与T管引流治疗复发性胆总管结石的效果及安全性分析[J]. 临床肝胆病杂志, 2026, 42(7): 1648-1655 DOI:10.12449/JCH260722

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复发性胆总管结石(recurrent choledocholithiasis,RCL)是指在胆总管结石取净6个月后再次出现的胆总管结石1,其总体发生率可达6.3%~21.0%2-5,是肝胆外科常见疾病。目前,国内外尚无针对RCL治疗的一致性指南或者共识,临床一线多参考胆总管结石的相关指南进行处理,治疗方式可分为内镜治疗与外科手术治疗。对于无胆肠吻合手术指征的RCL患者,内镜治疗与腹腔镜胆总管探查术(laparoscopic common bile duct exploration,LCBDE)均是安全有效的治疗方法6。然而,内镜治疗因其在治疗过程中可能损伤Oddi括约肌而备受争议,其术后结石复发风险高于其他术式7。LCBDE因创伤小、恢复快的优势,临床应用日趋广泛,且短期疗效显著8。在LCBDE中,胆总管的闭合方式分为T管引流(T-tube drainage,TTD)和一期缝合(primary duct closure,PDC)。本研究旨在通过对比两种术式的围手术期临床资料,为临床治疗决策的优化提供依据,进而改善患者的生活质量。

1 资料与方法

1.1 研究对象

收集2022年2月—2025年12月在华北理工大学附属医院肝胆外科接受LCBDE治疗的121例RCL患者的临床资料,根据术中胆总管闭合方式的不同,将患者分为PDC组(n=58)和TTD组(n=63)。纳入标准:(1)明确诊断为胆总管结石,影像学检查提示胆总管直径≥0.8 cm;(2)既往有胆总管结石手术史,无内镜治疗史;(3)Oddi括约肌功能正常,符合胆道探查手术适应证;(4)相关临床资料完整,无缺失。排除标准:(1)因腔镜技术无法完成而中转开腹;(2)存在结石合并肿瘤;(3)术中无法一次性取净胆总管结石;(4)存在中、重度以上黄疸,或胆总管内见脓性胆汁、大量胆泥或絮状物。

1.2 手术方法

(1)患者取平卧位,行气管插管全身麻醉。手术采用四孔法穿刺(脐下缘10 mm、剑突下10 mm、右锁骨中线肋缘下两横指5 mm、右腋前线肋缘下5 mm)。CO2压力设定为10~12 mmHg(1 mmHg=0.133 kPa)。充分暴露胆总管后,选取十二指肠上段纵向切开胆总管,术中根据实际情况调整切口长度。连接胆道镜,置入胆总管进行探查。观察肝总管、肝内胆管及胆总管有无畸形、肿瘤、脓性胆汁等情况。在双镜联合下进行取石,将结石全部取净后再次进镜,探查有无结石残留,Oddi括约肌功能、十二指肠乳头有无异常。反复冲洗胆道,直至胆汁清亮。(2)PDC组:选取4-0可吸收缝线或倒刺线缝合胆总管切口,放置腔镜纱布蘸取证实无胆漏及出血等情况。于文氏孔处放置1根橡胶引流管,自右侧腋前线Trocar引出并用缝线固定。(3)TTD组:根据术中情况,选取适宜型号的T管,置入胆总管内。选取4-0可吸收缝线或倒刺线缝合胆总管切口,缝合结束后用腔镜纱布轻蘸T管缝合处周围,确认无胆漏及出血。于小网膜孔处放置1根橡胶引流管,自腋前线Trocar引出体外并用缝线固定,T管自右侧肋缘下方Trocar引出体外并用缝线固定。

1.3 观察资料

收集临床资料:年龄、性别、基础疾病(高血压、糖尿病、心脏病)、术前总胆红素水平、术前胆总管直径、体重指数(body mass index,BMI)、美国麻醉医师协会(American Society of Anesthesiologists,ASA)分级、手术时间、胆总管处理方式、术后恢复进食时间、术后第1天引流量、术后拔除引流管时间、术后住院时间、术后第3天总胆红素水平、术后并发症情况、术后1周胆总管直径以及住院总费用。

1.4 统计学方法

本研究采用两独立样本优效性检验设计,样本量估算通过GPower3.1.9.79软件完成。以术后总并发症发生率为主要观察指标。参照同类研究结果10,设定TTD组预期并发症发生率为36.51%,PDC组预期并发症发生率为13.95%;α错误概率:0.05(双侧检验)。检验效能(1-β):0.80;分配比例:1∶1。经计算,所需总样本量为114例(即每组需57例)。本研究实际纳入121例患者,满足统计学检验效能要求。同时,采用适用于小样本数据的Fisher精确检验等方法,进一步增强研究结果的可信度。采用SPSS 23.0软件进行数据统计分析。符合正态分布的计量资料以x¯±s表示,两组间比较采用成组t检验;不符合正态分布的计量资料以MP25P75)表示,两组间比较采用Mann-Whitney U检验。计数资料两组间比较采用χ2检验或Fisher精确概率检验。P<0.05为差异有统计学意义。

2 结果

2.1 一般资料

术前:两组性别、年龄、ASA分级、高血压病、糖尿病、心脏病、术前总胆红素水平和胆总管术前直径比较,差异均无统计学意义(P值均>0.05)(表1)。术中: PDC组的手术时间为48.50(39.00~59.25)min,TTD组为55.00(46.00~69.00)min,两组比较差异有统计学意义(Z=-2.726,P=0.006),提示PDC组的手术时间显著短于TTD组。术后:与TTD组相比,PDC组术后第3天总胆红素水平恢复更快,术后恢复进食时间、术后拔除引流管时间及术后住院时间更短,住院总费用更低,术后恢复更接近于胆道正常的生理解剖结构(P值均<0.05)(表2)。

2.2 术后并发症情况

PDC组的术后电解质紊乱及总并发症发生率均显著低于TTD组(P值均<0.05)(表3)。

2.3 术后并发症危险因素分析

单因素分析结果显示,两组患者术前总胆红素水平、术前胆总管直径和手术方式比较,差异均有统计学意义(P值均<0.05)(表4)。

2.4 术后并发症的多因素Logistic回归分析

以患者术后有无并发症为因变量,将单因素分析中有统计学意义的指标纳入多因素Logistic回归分析。结果显示,术前胆总管直径<1.3 cm、术前总胆红素水平≥21.0 μmol/L是患者出现术后并发症的独立危险因素(P值均<0.05),而PDC术式为术后并发症的独立保护因素(P<0.05)(表5)。

3 讨论

胆总管结石可分为原发性和继发性两种类型,其形成假说包括胆汁淤积、胆道细菌感染、胆汁成分比例失衡等11。研究发现,在胆管取石术后胆总管结石复发的患者中,胆色素结石的比例显著高于胆固醇结石12。胆汁淤积及胆道感染是其主要的致病机制13。影响胆总管结石复发的因素包括年龄、BMI、胆总管直径、胆总管角度、壶腹周围憩室、首次取石方式、质子泵抑制剂药物的使用等14

临床上胆总管结石的治疗方法主要包括自然排石、内镜取石及切开胆总管取石。多项研究报道的自然排石率为17.6%~21%15。陈建等16通过构建预测模型指出,单发结石、胆总管不扩张、结石直径<8 mm、血清碱性磷酸酶及γ-谷氨酰转移酶水平降低是预测自发排石的关键变量。自然排石需要由临床医师依据具体情况实施,一旦患者出现腹痛加重、发热及黄疸等症状,则需行内镜治疗或外科手术治疗以解除梗阻。内镜治疗与LCBDE均是安全有效的治疗方法,因LCBDE具有不损伤Oddi括约肌功能、术后结石复发率低等优势,建议将其作为首选治疗方案17。Tian等18的研究显示,接受内镜治疗的患者结石复发的可能性是接受LCBDE患者的1.98倍,LCBDE是结石单次和多次复发的独立保护因素。相较于内镜治疗,LCBDE能够保留Oddi括约肌功能、减少结石复发;相较于开腹手术及胆肠吻合术,LCBDE又具有损伤小、恢复快、并发症少等优点。

在LCBDE治疗RCL过程中,PDC与TTD是关闭胆总管的两种主要术式19-20。然而,针对RCL手术方式的选择,国内外相关研究较为有限,哪种方式更合理、效果及安全性更优仍存在较大争议,目前国际上也尚未完全达成共识。

目前,LCBDE+TTD在临床应用中占据主导地位,而PDC提供了另一种不同的选择。研究表明,PDC的关键在于确保胆总管下段通畅,保证术中胆管内无残存结石、无胆管狭窄是手术的先决条件,满足这两项指标方可保障手术安全与远期疗效21-22。本研究对PDC的适应证总结如下:(1)术前腹部超声、计算机体层成像(computed tomography,CT)或磁共振胰胆管成像提示胆总管有结石,但术中探查明确为阴性1;(2)经术中胆道镜或胆道造影确认结石已完全取净,胆管黏膜无明显充血、水肿、糜烂或溃疡23;(3)胆总管下段存在暂时性痉挛或功能性梗阻,经术中探查排除器质性病变,胆管黏膜及管壁结构正常124;(4)无其他合并症,如肝内胆管结石、胆道占位性病变、胆道蛔虫等25;(5)胆总管直径处于正常范围或轻度扩张(通常≥0.8cm),管壁厚度正常,无纤维化、瘢痕化改变26-28。Hua等29提出,未扩张的胆总管(<0.8 cm)是LCBDE术后发生胆漏的风险因素;另有研究证实,行LCBDE后PDC的临床安全胆总管直径应≥0.8 cm30。为保证患者安全,本研究将其设为纳排标准。结石引发的慢性炎症会导致胆总管壁发生纤维化性增厚,不仅增加解剖与缝合的技术难度,也会阻碍管壁愈合。Liu等31通过多变量分析发现,胆管壁厚度≥2 mm是术后并发症的独立风险因素。本研究为回顾性设计,由于病例缺乏标准化的胆总管壁厚度测量记录,为避免因病例数据缺失而削弱统计效能,未将其设为纳排标准。

本研究对121例RCL患者两种不同术式的临床资料进行对比分析,结果显示,PDC组的手术时间更短,其主要原因在于减少了置入并固定T管的过程。PDC组术后第3天总胆红素水平显著低于TTD组,提示该术式避免了引流,保持了胆道的完整性和正常生理功能,有利于胆道功能的恢复32,这可能与术中缝合胆总管前需反复冲洗以确定无残留胆泥、脓性胆汁等操作有关33

LCBDE术后,通常待患者胃肠功能恢复后再嘱其进食。本研究显示,PDC组术后恢复进食时间更短,与王平等34对974例初次胆总管结石患者行PDC与TTD研究的结果一致。《胆道手术加速康复外科专家共识(2016版)》35指出,麻醉苏醒后于术后第1天进食流质饮食可促进胃肠道功能恢复,降低感染风险及术后并发症发生率。术中放置腹腔引流管有助于观察患者术后术区有无出血、胆漏等并发症,并可及时引出腹腔内渗液,减少并发症的发生。陈青等36的研究显示,胆管壁胶原含量、断裂强度在术后5~7 d可接近正常胆管组织水平。为降低患者胆漏风险,经上腹部CT检查确认术区无明显积液,PDC组患者于术后1周拔除腹腔引流管,而TTD组患者则在1周后逐步抬高T管,确认无胆漏后再拔除腹腔引流管,因此,PDC组术后住院时间及住院费用均更少。此外,PDC组电解质紊乱及总并发症的发生率更低;TTD组因术后需要持续引流,会引起大量胆汁丢失,从而诱发电解质紊乱。PDC组可以确保胆道的正常生理功能不受损害,避免胆盐、电解质的过多流失,且不放置T管,有利于患者早期离床活动,减少因卧床引起的肺部感染、下肢血栓形成等事件的发生。目前针对LCBDE术后胆总管直径变化的相关研究较少,本研究通过对术前CT及术后1周CT影像中胆总管直径的测量发现,PDC组更接近于胆总管正常的生理解剖结构。多因素Logistic回归分析显示,术前胆总管直径<1.3 cm、总胆红素水平≥21.0 μmol/L为术后并发症的独立危险因素,而PDC术式为术后并发症的独立保护因素(P<0.05)。王杰等37关于胆总管直径<1.0 cm增加并发症发生风险的结论可间接支持本研究。当胆总管较窄且胆红素水平较高时,提示胆总管梗阻情况严重。对于高风险患者(胆总管直径<1.3 cm或总胆红素水平≥21.0 μmol/L),PDC具有降低并发症发生的效果,这可能是因为胆总管直接行PDC,避免了留置T管对胆管黏膜的机械性损伤,抑制交感神经兴奋,从而减轻手术过程中应激引发的炎症反应,同时规避了T管对胆管组织压迫导致的胆汁淤积38

综上所述,在治疗效果相当的情况下,RCL患者行LCBDE+PDC可缩短手术时间,降低术后电解质紊乱及总并发症发生率,缩短术后住院时间,减少住院费用,同时保持胆道的完整性和正常生理功能,有利于胆道功能的恢复。

本研究为回顾性研究,存在样本量相对较低的局限性:(1)纳入病例均来自同一医院,受单中心影响,难以全面反映不同医疗中心及诊疗水平下两种术式的应用差异,也未纳入合并复杂基础疾病、特殊解剖结构的RCL患者,可能导致研究结果的外推性受限。(2)样本数量限制了亚组分析的深度,未能对PDC的疗效与安全性差异进行更细致地分层探讨,也未能分析术式与其他潜在危险因素的交互作用对术后并发症的影响。(3)本研究仅聚焦于近期疗效与安全性分析,对于术后结石远期复发、胆道功能恢复状况等关键结局指标缺乏系统记录以及长期随访,也难以发现低发生率的远期并发症。因此,所得结论尚需多中心、大样本临床研究进一步验证。

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河北省医学科学研究课题计划项目(20250927)

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