Biliary stents

胆道支架
  • 文章类型: Meta-Analysis
    目的:内镜胆道支架置入术是治疗恶性胆道梗阻(MBO)的重要手段。然而,MBO管理期间放置金属支架(MS)或塑料支架(PS)的最佳位置,无论是在Oddi(SO)括约肌上方(毛细管上)还是跨(经毛细管),还没有被彻底评估。这项荟萃分析旨在比较MBO患者的经内镜逆行胰胆管造影术(ERCP)引导的胆道支架放置在SO上方和上方的临床结果。
    方法:对电子数据库进行了全面搜索,以确定从开始到2022年4月发表的研究。检查的临床结果包括支架通畅,支架闭塞,和总体不良事件(AE),如胆管炎,ERCP术后胰腺炎(PEP),胆囊炎,支架迁移,和出血。随机效应模型或固定效应模型的选择是基于异质性的存在。
    结果:共分析了12篇文献,涉及751例患者。结果表明,与经乳头入路相比,经乳头入路的支架通畅性更长(平均差异:38.58;95%置信区间16.02-61.14,P<0.0001)。此外,毛细血管上入路与较低的支架闭塞风险和总体不良事件相关(分别为P=0.04,P=0.002),特别是在PEP的发生率(P=0.009)。胆管炎的发病率,胆囊炎,支架迁移,乳头上和经乳头入路的出血情况相似。亚组分析表明,毛细血管上PS在支架闭塞的发生率和更长的支架通畅性方面显着降低。而与经乳头入路相比,在总体AE和PEP的发生率方面有显著下降.
    结论:与经乳头法相比,毛细血管上支架在更长的支架通畅性方面具有优势,支架闭塞和总体不良事件发生率较低,尤其是,PEP发生率较低。胆管炎的发病率,胆囊炎,支架迁移,乳头上和经乳头入路的出血情况相似。需要进一步的大规模随机对照研究来证实我们的发现。
    背景:CRD4202236435.
    Endoscopic biliary stenting is an essential treatment for malignant biliary obstruction (MBO). However, the optimal location for the placement of metal stents (MS) or plastic stents (PS) during the management of MBO, whether above (suprapapillary) or across (transpapillary) the sphincter of Oddi (SO), has not been thoroughly evaluated. This meta-analysis aims to compare the clinical outcomes associated with endoscopic retrograde cholangiopancreatography (ERCP)-guided biliary stents placed above and across the SO in patients with MBO.
    A comprehensive search of electronic databases was carried out to identify studies published from inception to April 2022. The clinical outcomes examined including stent patency, stent occlusion, and overall adverse events (AEs) such as cholangitis, post-ERCP pancreatitis (PEP), cholecystitis, stent migration, and bleeding. The selection of a random-effects model or fixed-effects model was based on the presence of heterogeneity.
    A total of 12 articles involving 751 patients were analyzed. The findings showed that the suprapapillary approach had longer stent patency compared to the transpapillary approach (mean difference: 38.58; 95% confidence interval 16.02-61.14, P < 0.0001). Additionally, the suprapapillary approach was associated with a lower risk of stent occlusion and overall AEs (P = 0.04, P = 0.002, respectively), particularly in the incidence of PEP (P = 0.009). The incidence of cholangitis, cholecystitis, stent migration, and bleeding were similar between the suprapapillary and transpapillary approaches. The subgroup analyses indicated that suprapillary PS had a significant decrease in the incidence of stent occlusion and longer stent patency, while suprapillary MS had a significant decrease in the incidence of overall AEs and PEP than the transpapillary approach.
    Compared with the transpapillary approach, the suprapapillary stent had superiority in longer stent patency, lower rates of stent occlusion and overall AEs, and notably, a lower incidence of PEP. The incidence of cholangitis, cholecystitis, stent migration, and bleeding were similar between the suprapapillary and transpapillary approaches. Further large-scale randomized controlled studies are needed to confirm our findings.
    CRD42022336435.
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  • 文章类型: Meta-Analysis
    目的:胰胆管肿瘤的诊断仅通过影像学方法具有挑战性。虽然执行EUS的最佳时刻没有很好的定义,有人认为,胆道支架的存在可能会干扰肿瘤的正确分期和样本的获取。我们进行了一项荟萃分析,以评估胆道支架对EUS引导的组织获取率的影响。
    方法:我们在不同的数据库中进行了系统综述,比如PubMed,科克伦,Medline,OVID数据库。搜索了截至2022年2月发表的所有研究。
    结果:分析了8项研究。共纳入3185例患者。平均年龄为66.9±2.7岁;55.4%为男性。总的来说,1761例患者(55.3%)接受EUS引导组织采集(EUS-TA)原位支架,而1424例患者(44.7%)在没有支架的情况下接受了EUS-TA。两组的技术成功率相似(EUS-TA有支架:88%vsEUS-TA无支架:88%,OR=0.92[95%CI0.55-1.56])。支架的类型,两组的针头大小和通过次数相似.
    结论:EUS-TA在有或没有支架的患者中具有相似的诊断性能和技术成功。支架的类型(SEMS或塑料)似乎不影响EUS-TA的诊断性能。未来的前景和RCT研究需要加强这些结论。
    OBJECTIVE: Pancreatobiliary tumours are challenging to diagnose exclusively by imaging methods. Although the optimum moment for carrying out the EUS is not well defined, it has been suggested that the presence of biliary stents may interfere with the proper staging of tumours and the acquisition of samples. We performed a meta-analysis to evaluate the impact of biliary stents on EUS-guided tissue acquisition yield.
    METHODS: We conducted a systematic review in different databases, such as PubMed, Cochrane, Medline, and OVID Database. A search was made of all studies published up to February 2022.
    RESULTS: Eight studies were analyzed. A total of 3185 patients were included. The mean age was 66.9±2.7 years; 55.4% were male gender. Overall, 1761 patients (55.3%) underwent EUS guided tissue acquisition (EUS-TA) with stents in situ, whereas 1424 patients (44.7%) underwent EUS-TA without stents. The technical success was similar in both groups (EUS-TA with stents: 88% vs EUS-TA without stents: 88%, OR=0.92 [95% CI 0.55-1.56]). The type of stent, the needle size and the number of the passes were similar in both groups.
    CONCLUSIONS: EUS-TA has similar diagnostic performance and technical success in patients with or without stents. The type of stent (SEMS or plastic) does not seem to influence the diagnostic performance of EUS-TA. Future prospectives and RCT studies are needed to strengthen these conclusions.
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  • 文章类型: Journal Article
    目的:自膨式金属支架(SEMS)广泛用于缓解远端恶性胆道梗阻(dMBO)。然而,以往比较未覆盖支架(UCSEMS)和覆盖支架(FCSEMS)结果的研究报告结果相互矛盾.这项大型队列研究旨在比较UCSEMS和FCSEMS对dMBO的临床结果。
    方法:在2017年5月至2021年5月期间接受UCSEMS或FCSEMS安置的dMBO患者中进行了一项回顾性队列研究。主要结果是临床成功率,不良事件(AE),和计划外的内镜再干预。次要结果包括不良事件类型,无介入支架通畅,以及支架闭塞的管理和结果。
    结果:该队列包括454名患者(364名UCSEMS;90名FCSEMS)。中位随访时间为9.6个月,两组间相似。UCSEMS和FCSEMS具有相当的临床成功率(p=0.250)。然而,UCSEMS的不良事件发生率(33.5%vs21.1%;p=0.023)和非计划的内镜再干预(27.0%vs11.1%;p=0.002)明显更高。UCSEMS的支架闭塞率较高(26.9%vs.8.9%;p<0.001)和更短的支架闭塞中位时间(4.4vs10.7个月;p=0.002)。FCSEMS组无支架再介入生存率较高。FCSEMS的支架移动率明显较高(7.8%vs1.1%;p<0.001),但胆囊炎(0.3%vs1.1%;p=0.872)和ERCP后胰腺炎(6.3%vs6.6%;p=0.90)的发生率相似。当UCSEMS阻塞时,与同轴SEMS置入相比,同轴塑料支架置入的支架再闭塞率更高(46.7%vs19.7%;p=0.007).
    结论:由于不良事件发生率较低,因此应考虑使用FCSEMS来缓解dMBO。更长的通畅率,和较低的非计划内镜干预率。
    Self-expandable metal stents (SEMSs) are widely used for palliation of distal malignant biliary obstruction (dMBO). However, previous studies comparing the outcomes between uncovered SEMSs (UCSEMSs) and fully covered SEMSs (FCSEMSs) report conflicting results. This large cohort study aimed to compare the clinical outcomes between UCSEMSs and FCSEMSs for dMBO.
    A retrospective cohort study was performed in patients with dMBO who underwent either UCSEMS or FCSEMS placement between May 2017 and May 2021. Primary outcomes were rates of clinical success, adverse events (AEs), and unplanned endoscopic reintervention. Secondary outcomes were types of AEs, intervention-free stent patency, and management and outcomes of stent occlusion.
    The cohort included 454 patients (364 in the UCSEMS group and 90 in the FCSEMS group). Median follow-up duration was 9.6 months and was similar between the 2 groups. Use of UCSEMSs and FCSEMSs had comparable clinical success (P = .250). However, use of UCSEMSs had significantly higher rates of AEs (33.5% vs 21.1%; P = .023) and unplanned endoscopic reintervention (27.0% vs 11.1%; P = .002). UCSEMSs had a higher rate of stent occlusion (26.9% vs 8.9%; P < .001) and shorter median time to stent occlusion (4.4 months vs 10.7 months; P = .002). Stent reintervention-free survival was higher in the FCSEMS group. FCSEMSs had a significantly higher rate of stent migration (7.8% vs 1.1%; P < .001), but patients in the FCSEMS group had similar rates of cholecystitis (.3% vs 1.1%; P = .872) and post-ERCP pancreatitis (6.3% vs 6.6%; P = .90). When UCSEMSs did occlude, placement of a coaxial plastic stent had a higher rate of stent reocclusion compared with coaxial SEMS placement (46.7% vs 19.7%; P = .007).
    FCSEMSs should be considered for the palliation of dMBO because of lower rates of AEs, longer patency rates, and lower rates of unplanned endoscopic intervention.
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  • 文章类型: Journal Article
    留置胆道支架的胆汁淤积通常会导致内镜逆行胰胆管造影(ERCP)后结石复发。胆道支架,包括金属和不可降解的塑料支架由于其许多优异的性能而广泛用于临床设置。然而,传统的胆道支架仍然具有较差的抗菌活性和抗胆汁粘连,导致受伤,局部成纤维细胞增殖。目前,已经制备了各种胆道支架涂层以满足临床需求。在这次审查中,我们首先总结和讨论胆道支架的分类和抗菌/抗生物膜机制。然后,本文综述和讨论了开发抗菌和抗生物膜涂层以改善胆道支架性能的最新进展。最后,我们列出了胆道支架涂层和胆道支架未来发展的几个可能方向,如抗胆汁粘连涂层,多功能涂层,药物洗脱可生物降解胆道支架和3D打印胆道支架。
    Cholestasis of the indwelling biliary stents usually leads to stone recurrence after endoscopic retrograde cholangio pancreatoraphy (ERCP). Biliary stents, including metallic and none-degradable plastic stents are widely used in clinical settings due to their many excellent properties. However, conventional biliary stents still suffer from poor antibacterial activity and anti-bile-adhesion, which lead to injured, local fibroblasts proliferating. Currently, various coatings for biliary stents have been prepared to meet the clinical demands. In this review, we start by summarizing and discussing classifications of biliary stents and antibacterial/antibiofilm mechanism. Then, the latest advances about developing antibacterial and antibiofilm coatings for improving the properties of biliary stents are reviewed and discussed in detail. Lastly, we list several possible directions for future development of biliary stents coatings and biliary stent, such as anti-bile-adhesion coating, multifunctional coating, drug-eluting biodegradable biliary stents and 3D printed biliary stents.
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  • 文章类型: Journal Article
    目的:目前用于预防手术胆道吻合口狭窄的引流管不易自然取出。如果使用可生物降解材料的排水管很容易获得,并且管子的降解时间得到了很好的控制,手术吻合口狭窄和纤维化是可以预防的。这项动物研究的目的是评估新型可生物降解支架(BS)对胆管到胆管(DD)胆管吻合术后胆管狭窄和纤维化的预防作用。
    方法:将10只小型猪分配到对照组(n=5)和/或支架组(n=5)。通过开腹手术暴露胆总管,然后横向切除。在支架组中,根据胆管的宽度插入4毫米或6毫米聚二恶烷酮/镁鞘芯BS,其次是DD胆道吻合术。在对照组中,在不插入BS的情况下进行DD胆道吻合。
    结果:在支架组中,在所有动物中观察到支架长达4周没有畸形。八周后,组织病理学检查显示,与支架组相比,对照组吻合部位的胆总管周长相对较窄。对照组的纤维化程度明显高于支架组(3.84mmvs.0.68mm,分别;P<0.05)。
    结论:我们的研究表明,新型BS在足够的时间内保持其原始形状和径向力,然后消失而无不良事件。BS可以预防DD胆道吻合术后并发症和狭窄。
    OBJECTIVE: The current drain tubes for preventing surgically biliary anastomotic stricture are not naturally and easily removed. If a drain tube using biodegradable material is easily available and the degradation time of the tube is well controlled, surgical anastomotic stricture and fibrosis could be prevented. The aim of this animal study was to evaluate the preventive effect of novel biodegradable stents (BS) on biliary stricture and fibrosis after duct-to-duct (DD) biliary anastomosis.
    METHODS: Ten mini-pigs were allocated to the control group (n = 5) and or the stent group (n = 5). The common bile duct was exposed through surgical laparotomy and then resected transversely. In the stent group, a 4-mm or 6-mm polydioxanone/magnesium sheath-core BS was inserted according to the width of the bile duct, followed by DD biliary anastomosis. In the control group, DD biliary anastomosis was performed without BS insertion.
    RESULTS: In the stent group, stents were observed without deformity for up to 4 weeks in all animals. Eight weeks later, histopathologic examination revealed that the common bile duct of the anastomosis site was relatively narrower in circumference in the control group compared to the stent group. The degree of fibrosis in the control group was more marked than in the stent group (3.84 mm vs. 0.68 mm, respectively; P < 0.05).
    CONCLUSIONS: Our study showed that novel BS maintained their original shape and radial force for an adequate time and then disappeared without adverse events. The BS could prevent postoperative complications and strictures after DD biliary anastomosis.
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  • 文章类型: Journal Article
    BACKGROUND: The outcome of percutaneous cholecystostomy (PC) in malignant patients with acute cholecystitis (AC) after biliary stent insertion has not been investigated in a large group.
    OBJECTIVE: To evaluate the clinical outcomes of PC for AC after stent insertion in patients with malignant biliary obstruction.
    METHODS: From April 2007 to February 2019, 107 patients (57 men, 52 women; mean age = 67.5 years; age range = 27-93 years) who had undergone PC for AC after biliary stent insertion were retrospectively evaluated. Of the 107 patients, 86 underwent biliary stent insertion by the endoscopic approach and the remaining 21 patients by the percutaneous approach. All patients were classified into three groups: those with stent-induced AC; those with cancer-induced AC; and those with AC without mechanical cause (biliary stent, GB stone, or cancer invasion). The mean survival time, recurrence rate, symptom improvement, and cystic duct patency in each patient group were analyzed.
    RESULTS: Stent-induced AC (n = 40, 37.4%) developed with a mean onset time of six days (range = 0-14 days), AC without mechanical cause (n = 27, 25.2%), 87 days (range = 15-273 days), and cancer-induced AC (n = 40, 37.4%), 137 days (range = 15-447 days) after stent insertion. Symptom resolution and significant improvement in laboratory test values were achieved in 95 patients (88.8%) within four days after PC.
    CONCLUSIONS: PC is a technically safe and effective method for the treatment of AC after biliary stent insertion in patients with malignant biliary obstruction.
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  • 文章类型: Journal Article
    保留在原位超过12个月的塑料胆道支架,称为被遗忘的胆道支架(FBS),会引起胆管炎等并发症,支架迁移,支架闭塞,和穿孔。
    回顾性分析2016年12月至2020年12月接受ERCP手术的患者的病历。关于患者特征的数据,ERCP和支架置入的适应症,支架类型,支架置入持续时间,并发症,FBS的原因来自医院的数据库。
    共分析48例FBS。患者的平均年龄(SD)为71.23岁(±12.165),男女比例为23/25(0.92),平均支架置入时间为27.12个月(范围:12-84个月)。胆道支架置入术最常见的适应症是无法修复的胆总管结石(40/48)。结石形成(79%)和近端支架移位(26.4%)是最常见的并发症。FBS组的患者年龄明显大于及时取出支架的患者(71.23vs.62.43年,p<0.001)。在所有情况下都可以进行内窥镜治疗;在任何情况下都不需要手术。患者引用的FBS的最常见原因是没有被告知需要长期管理其支架(n=14,29.2%)。
    FBS是潜在的问题,特别是在老年患者中。与患者沟通以提醒他们需要支架管理对于预防FBS很重要。
    Plastic biliary stents that remain in situ for more than 12 months, called forgotten biliary stents (FBSs), can cause complications such as cholangitis, stent migration, stent occlusion, and perforation.
    The medical records of patients who underwent ERCP procedures from December 2016 to December 2020 were analysed retrospectively. Data on patient characteristics, indications for ERCP and stenting, stent types, stenting duration, complications, and causes of FBSs were obtained from the hospital’s database.
    A total of 48 cases with FBSs were analysed. The mean age (SD) of the patients was 71.23 years (±12.165), the male-to-female ratio was 23/25 (0.92), and the mean stenting duration was 27.12 months (range: 12–84 months). The most common indication for biliary stenting was irretrievable choledochal stones (40/48). Stone formation (79%) and proximal stent migration (26.4%) were the most frequent complications. The patients in the FBS group were significantly older than those from whom stents were removed in a timely manner (71.23 vs. 62.43 years, p < 0.001). Endoscopic treatment was possible in all cases; surgery was not required in any case. The most common cause of FBSs cited by patients was not having been informed about the need for long-term management of their stents (n = 14, 29.2%)
    FBSs are potentially problematic particularly in elderly patients. Communication with the patient to remind them of the need for stent management is important for preventing FBSs.
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  • 文章类型: Journal Article
    目的:与胆道生物可降解支架(BS)相关的临床结果和不良事件的发生率可能因降解过程和时间而异。本研究的目的是观察不同BS原型的降解过程和时间,并评估其机械性能的顺序变化。
    方法:使用体外胆汁流模型,我们比较了降解时间,径向力变化,和四种不同的BS原型之间的形态学变化:聚二恶烷酮(PDO)BS,聚乙交酯(PGA)BS,聚二恶烷酮/聚乳酸(PDO/PLLA)鞘芯BS,和聚二恶烷/镁(PDO/Mg)鞘芯BS。使用体内猪胆管扩张模型,我们进行了直接经口胆道镜(DPOC)检查,以定期观察生物降解过程和相关不良事件.
    结果:在胆汁流模型中,PGABS和PDO/MgBS原型显示出快速的径向力降低和形态变化,并在六周内完全降解。PDO/PLLABS保持较高的径向力,并保持其原始形状比PDOBS更长,长达16周。将总共24个BS插入12只猪的扩张胆管中。在这个动物模型中,DPOC检查显示,PDOBS和PDO/PLLABS保持其原始形状约12周,但是PDOBS显示出更大程度的碎裂,并引起胆道结石和胆管阻塞。
    结论:我们的结果表明,PDO/PLLABS在相对较长的时间内保持其原始形状和径向力,并将不良事件降至最低。
    OBJECTIVE: The clinical outcomes and prevalence of adverse events associated with biliary biodegradable stents (BS) can differ according to degradation process and time. The aim of this study was to observe the degradation process and time of different BS prototypes, and to evaluate sequential changes in their mechanical properties.
    METHODS: Using an in vitro bile flow phantom model, we compared degradation time, radial force changes, and morphologic changes among four different BS prototypes: polydioxanone (PDO) BS, polyglycolide (PGA) BS, polydioxanone/poly-l-lactic acid (PDO/PLLA) sheath-core BS, and polydioxaone/magnesium (PDO/Mg) sheath-core BS. Using an in vivo swine bile duct dilation model, we performed a direct peroral cholangioscopy (DPOC) examination to observe the biodegradation process and related adverse events at regular intervals.
    RESULTS: In the bile flow phantom model, the PGA BS and PDO/Mg BS prototypes showed rapid radial force reduction and morphological changes and complete degradation within six weeks. PDO/PLLA BS maintained high radial force and kept their original shape for longer than the PDO BS, up to 16 weeks. A total of 24 BS were inserted into the dilated bile ducts of 12 swine. In this animal model, DPOC examination revealed that PDO BS and PDO/PLLA BS maintained their original shapes for approximately 12 weeks, but PDO BS showed a greater degree of fragmentation and induced biliary stones and bile duct obstruction.
    CONCLUSIONS: Our results showed that PDO/PLLA BS maintained their original shape and radial force for a relatively long time and minimized adverse events.
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  • 文章类型: Journal Article
    胆管的几种炎症引起狭窄,阻止胆汁排入胃肠道。重建胆汁流的非药物治疗包括在内窥镜逆行胰胆管造影(ERCP)过程中插入胆管的塑料或自膨胀金属支架(SEM)。这项研究的重点是3D打印具有组织样机械性能的肝外胆管(EHBDs)的解剖学精确模型,以改善支架原型的体外测试。在通过计算机辅助设计(CAD)生成EHBD模型之后,我们测试了FormlabsSLA3D打印机使用基于所需机械性能选择的聚合物精确打印模型的能力。我们发现打印机在使用候选聚合物打印尺寸精确的EHBD模型方面是可靠的。接下来,我们评估了模板弹性(FE)的力学性能,Flexible(FF),和耐久(FD)树脂在暴露于水之前和之后,盐水,或胆汁酸溶液在37°C下长达一周。FE根据其弹性模量具有最类似胆管的机械性能,断裂伸长率百分比,以及在所有液体暴露条件下的质量变化。FE打印的EHBD模型在胆道支架展开期间或插入导管连接器时没有功能损伤。并提供了部署支架的高水平可视化。这些结果表明,我们的3D打印EHBD模型有助于胆道支架原型的临床前体外测试。
    Several inflammatory conditions of the bile ducts cause strictures that prevent the drainage of bile into the gastrointestinal tract. Non-pharmacological treatments to re-establish bile flow include plastic or self-expanding metal stents (SEMs) that are inserted in the bile ducts during endoscopic retrograde cholangiopancreatography (ERCP) procedures. The focus of this study was to 3D print an anatomically accurate model of the extrahepatic bile ducts (EHBDs) with tissue-like mechanical properties to improve in vitro testing of stent prototypes. Following generation of an EHBD model via computer aided design (CAD), we tested the ability of Formlabs SLA 3D printers to precisely print the model with polymers selected based on the desired mechanical properties. We found the printers were reliable in printing the dimensionally accurate EHBD model with candidate polymers. Next, we evaluated the mechanical properties of Formlabs Elastic (FE), Flexible (FF), and Durable (FD) resins pre- and post-exposure to water, saline, or bile acid solution at 37 °C for up to one week. FE possessed the most bile duct-like mechanical properties based on its elastic moduli, percent elongations at break, and changes in mass under all liquid exposure conditions. EHBD models printed in FE sustained no functional damage during biliary stent deployment or when tube connectors were inserted, and provided a high level of visualization of deployed stents. These results demonstrate that our 3D printed EHBD model facilitates more realistic pre-clinical in vitro testing of biliary stent prototypes.
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  • 文章类型: Journal Article
    BACKGROUND: The present study aimed to determine the optimal timing of pancreaticoduodenectomy (PD) following preoperative biliary drainage (PBD) with consideration of postoperative morbidity and survival.
    METHODS: Between January 2007 and December 2015, consecutive 1,568 patients underwent PD at a single institution. Their data were reviewed retrospectively.
    RESULTS: Of all, 831 patients underwent PBD. The mean duration between drainage and surgery was 16.9 days. Regarding postoperative outcomes, length of hospital stay was longer in the drainage group (P = 0.028). Postoperative pancreatic fistula was not significantly different between the non-drainage and drainage groups (P = 0.162), but major complications occurred more frequently in the drainage group (P = 0.002). Multivariable analysis showed major complications occurred significantly at third and fourth weeks (odds ratios 1.863 and 2.523) after PBD, whereas early surgery performed in the first 2 weeks did not noticeably increase postoperative complications. In multivariable survival comparison, weekly interval beyond 6 weeks was associated with poor survival in those with pancreatic cancer, while patients with bile duct cancer operated on at the fourth week showed worse prognosis.
    CONCLUSIONS: Early surgery that reduces the operative delay after PBD may improve both short- and long-term postoperative outcomes in cancer patients undergoing PBD.
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