Current status of endoscopic biliary drainage for unresectable malignant hilar biliary strictures

The management of jaundice and cholangitis is important for improving the prognosis and quality of life of patients with unresectable malignant hilar biliary strictures (UMHBS). In addition, effective chemotherapy, such as a combination of gemcitabine and cisplatin, requires the successful control of jaundice and cholangitis. However, endoscopic drainage for UMHBS is technical demanding, and continuing controversies exist in the selection of the most appropriate devices and techniques for stent deployment. Although metallic stents (MS) are superior to the usual plastic stents in terms of patency, an extensive comparison between MS and “inside stents”, which are deployed above the sphincter of Oddi, is necessary. Which techniques are preferred remains as yet unresolved: for instance, whether to use a unilateral or bilateral drainage, or a stent-in-stent or side-by-side method for the deployment of bilateral MS, although a new cell design and thin delivery system for MS allowed us to accomplish successful deployments of bilateral MS. The development of techniques and devices for re-intervention after stent occlusion is also imperative. Further critical investigations of more effective devices and techniques, and increased randomized controlled trials are warranted to resolve these important issues.     

Long-term follow-up of patients with hilar malignant stricture treated by endoscopic internal biliary drainage

Seventy patients with biliary obstruction secondary to hilar tumors underwent attempted endoscopic internal biliary drainage using large transpapillary stents between December 1981 and March 1986. Placement of one or more stents was successful in 68. The type of stricture and mode of treatment were more important in determining subsequent survival than the type of tumor. In type II and III malignant strictures of the bifurcation of the common hepatic duct and the main hepatic duct, use of two or more stents to achieve complete drainage of the biliary system improves survival compared to incomplete drainage (176 vs. 119 days) and reduces procedure-related mortality and the incidence of early and late cholangitis. Patients with hilar tumors causing type II and III strictures treated with placement of multiple stents have at least as good a prognosis as patients with tumor involving only the common hepatic duct treated with use of a single stent. Once ERCP is performed and palliative endoscopic management of bifurcation tumors is begun, it must completed as soon as possible.     

Unilateral versus bilateral endoscopic metal stenting for malignant hilar biliary obstruction

Background and Aim: The extent of liver drainage for palliative treatment of malignant hilar biliary obstruction is controversial. The aim of this study was to compare endoscopic unilateral versus bilateral drainage in patients with malignant hilar biliary obstruction using a self‐expanding metal stent (SEMS). Methods: We carried out a retrospective review of 46 consecutive patients with malignant hilar biliary obstruction who were treated by endoscopic biliary drainage using SEMS between 1997 and 2005. Unilateral metal stenting (group A) was performed in 17 patients between 1997 and 2000, and bilateral metal stenting (group B) was performed in 29 patients between 2001 and 2005. The successful stent insertion, successful drainage, early complications, late complications, stent patency, and survival rate for groups A and B were evaluated and compared retrospectively. Results: There were no significant differences between the two groups in successful stent insertion (100% vs 90%, group A vs B, respectively), successful drainage (100% vs 96%), early complications (0% vs 10%), or late complications (65% vs 54%). Cumulative stent patency was significantly better in group B than in group A (P = 0.009). In cases of cholangiocarcinoma, cumulative stent patency was significantly better in group B than in group A (P = 0.009), whereas there were no inter‐group differences for gallbladder carcinoma. Cumulative survival did not differ significantly between the groups. Conclusions: Endoscopic bilateral drainage using SEMS for malignant hilar biliary obstruction is more effective than unilateral drainage in terms of cumulative stent patency, especially in cases of cholangiocarcinoma.     

Clinical evaluation of the Haber RAMPTM catheter for endoscopic bilateral metal stent placement in patients with malignant hilar strictures

Background: Endoscopic bilateral expandable metal stent (EMS) placement has been performed in malignant hilar strictures. To perform EMS placement successfully, insertion of guidewires into the bilateral intrahepatic bile ducts is an important and necessary step. In the present study, we evaluated the usefulness of the Haber RAMP^TM catheter (HRC) for the selective insertion of guidewires. Methods: EMS placement was performed in 17 patients with malignant hilar strictures. As the HRC has three lumens connected to apertures facing in different directions, the direction of the guidewire can be controlled at the catheter tip. Insertion of guidewires into bilateral intrahepatic bile ducts was attempted with and without the HRC. Results: The success rate of guidewire insertion into the bilateral intrahepatic bile ducts was 100% (7/7) when the HRC was used, whereas it was 50% (5/10) without the HRC. In the five patients with insertion failure, reinsertion was successfully performed using the HRC. The time required for the bilateral insertion of guidewires was reduced using the HRC. Bilateral EMSs placement was successful in 14 of the 17 patients (82%). Conclusions: The HRC was very useful for the accurate and rapid bilateral insertion of guidewires.     

Unilateral versus bilateral endoscopic hepatic duct drainage in patients with malignant hilar biliary obstruction: results of a prospective, randomized, and controlled study

BACKGROUND: The necessity for drainage of both liver lobes in tumors arising at the biliary bifurcation is controversial. The aim of this study was to compare the outcome of unilateral versus bilateral drainage in patients with biliary obstruction at the hilum. METHODS: One hundred fifty-seven consecutive patients with primary cholangiocarcinoma, gallbladder cancer, or periportal lymph node metastases were randomly allocated to unilateral (group A) or bilateral (group B) hepatic duct drainage. RESULTS: In intention-to treat analysis, group A had a significantly higher rate of successful endoscopic stent insertion than group B (88.6% vs. 76.9%, p = 0.041). Group B had a significantly higher rate of complications than group A (26.9% vs. 18.9%, p = 0.026) because of the higher rate of early cholangitis (16.6% vs. 8.8%, p = 0.013). In per-protocol analysis the rate of successful drainage, complications, and mortality did not differ between the two groups. Median survival did not differ between the two groups but was significantly different for patients with cholangiocarcinoma and those with gallbladder cancer versus patients with metastatic tumors (p = 0.0247). CONCLUSION: The insertion of more than one stent would not appear justified as a routine procedure in patients with biliary bifurcation tumors.     

内镜双支架引流术治疗晚期肝门部胆管恶性梗阻的疗效评价

目的评价内镜下双支架引流术治疗晚期肝门部胆管恶性梗阻的疗效。方法2007年1月至2010年12月接受内镜下双支架引流治疗的晚期肝门部胆管恶性梗阻患者28例（双支架组）,男15例、女13例,年龄44—88岁,中位年龄66．4岁,其中BismuthII型9例,Ⅲa型8例,IIIb型5例,Ⅳ型6例;同期接受内镜下单支架引流治疗的晚期肝门部胆管恶性梗阻患者23例（单支架组）作为对照,男11例、女12例,年龄42～83岁,中位年龄65．8岁,其中Bismuth11型7例,IIa型5例,IIIb型6例,Ⅳ型5例。对2组引流成功率、并发症发生率、平均支架通畅时间及平均生存时间进行对比分析。结果2组支架均成功置入,无死亡病例。引流有效率、并发症发生率双支架组分别为96．4％（27／28）和17．9％（5／28）,单支架组分别为87．0％（20／23）和13．0％（3／23）,2组比较差异无统计学意义（P〉0．05）。双支架组失访5例,随访率82．1％（23／28）;单支架组失访4例,随访率82．6％（19／23）。双支架组随访的23例患者的平均支架通畅时间、平均生存时间分别为（129±48．5）d和（187±94．5）d,单支架组随访的19例患者的平均支架通畅时间、平均生存时间分别为（102±37．8）d和（103±98．5）d,双支架组均明显优于单支架组（P〈0．05）。结论BismuthII型以上的肝门部胆管恶性梗阻行内镜下双支架引流是安全可行的,其平均支架通畅时间和平均生存时间均优于内镜下单支架引流。     

肝门部恶性胆道梗阻单、双侧引流的荟萃分析

目的 评价肝门部恶性胆道梗阻单、双侧引流的有效性与安全性. 方法 联合检索PubMed、Embase、Cochrane Library数据库,检索年限均从1975年至2013年8月,纳入单、双侧引流的随机对照和非随机对照试验.用RevMan5.0软件进行荟萃分析,用相对危险度(RR)值及95％可信区间(CI)对单、双侧引流进行比较.在荟萃分析中用RR及其95％CI比较两组差异.混合性的数据资料采用固定效应模型和随机效应模型,当研究间出现显著异质性时,荟萃分析采用随机效应模型.研究之间的异质性检验采用卡方检验(P＜ 0.10为异质性有统计学意义)和I2分析(I2＞ 50％为异质性有统计学意义).对于异质性的来源采用亚组分析和敏感性分析,潜在的发表偏倚采用漏斗图分析. 结果 经过筛选共纳入3个随机对照试验和7个观察性研究,合计894例患者.荟萃分析结果显示主要观察重点:单、双侧引流的支架通畅率优于单侧(RR=2.03,95％CI:1.16 ～ 3.56,P=0.01);而引流的有效性(RR=1.07,95％CI:0.97～1.18,P=0.20)和患者的生存率(RR=-0.16,95％CI:-0.40 ～ 0.08,P=0.20)差异无统计学意义.次要观察重点:单双侧引流的技术成功率(RR=1.05,95％CI:0.98 ～ 1.17,P=0.34)、早期并发症(RR=1.15,95％CI:0.75 ～ 1.76,P=0.52)、晚期并发症(RR=1.09,95％CI:0.75 ～ 1.60,P=0.65)、30 d病死率(RR=0.68,95％CI:0.38 ～ 1.23,P=0.20)同样差异没有统计学意义. 结论 虽然双侧引流支架通畅率较单侧好,现存循证医学证据还不足够支持双侧引流,期待更多严格设计前瞻性随机对照研究出现来验证.     

Contrast-free unilateral endoscopic palliation in malignant hilar biliary obstruction: new method

BACKGROUND: Bilateral endoscopic drainage is difficult in malignant hilar biliary obstruction. Recently, unilateral drainage in malignant hilar biliary obstruction has been shown to be equally effective. However, contrast injection leads to cholangitis. There have been no reported studies on contrast-free metal stenting in malignant hilar biliary obstruction. The present study was undertaken to evaluate the results of contrast-free unilateral metal stenting in type II malignant hilar biliary obstruction. METHODS: We prospectively studied the results of unilateral metal stenting in type II malignant hilar biliary obstruction without contrast injection in 18 patients. RESULTS: A successful endoscopic drainage was achieved in 100% (18/18) of patients with hilar strictures. Cholangitis and 30-day mortality occurred in none. CONCLUSIONS: Unilateral endoscopic metal stenting without contrast in type II malignant hilar biliary obstruction is a safe and effective method of palliation.     

Oncological benefit of preoperative endoscopic biliary drainage in patients with hilar cholangiocarcinoma

Due to advances in endoscopic equipment and techniques, preoperative endoscopic biliary drainage (EBD) has been developed to serve as an alternative to percutaneous transhepatic biliary drainage (PTBD). This study sought to clarify the benefit of EBD in comparison to PTBD in patients who underwent radical resections of hilar cholangiocarcinoma. One hundred and forty‐one patients underwent radical surgery for hilar cholangiocarcinoma between 2000 and 2008 were retrospectively divided into two groups based on the type of preoperative biliary drainage, PTBD (n = 67) or EBD (n = 74). We investigated if the different biliary drainage methods affected postoperative survival and mode of recurrence after median observation period of 82 months. The survival rate for patients who underwent EBD was significantly higher than those who had PTBD (P = 0.004). Multivariate analysis revealed that PTBD was one of the independent factors predictive of poor survival (hazard ratio: 2.075, P = 0.003). Patients with PTBD more frequently developed peritoneal seeding in comparison to those who underwent EBD (P = 0.0003). PTBD was the only independent factor predictive of peritoneal seeding. In conclusion, EBD might confer an improved prognosis over PTBD due to prevention of peritoneal seeding, and is recommended as the initial procedure for preoperative biliary drainage in patients with hilar cholangiocarcinoma.     

Unilateral versus bilateral Y-type stent-in-stent metal stent insertions in inoperable malignant hilar biliary strictures: A multicenter retrospective study

BackgroundTo date, there is controversy regarding unilateral versus bilateral stent placement in patients with malignant hilar biliary strictures (MHBSs). The aim of this study was to compare the clinical outcomes and complications of unilateral and bilateral (stent-in-stent method) stent placements for these patients.MethodsWe conducted a multicenter retrospective analysis of patients with inoperable MHBS who underwent endoscopic self-expandable metal stent (SEMS) placement from January 2009 to December 2019. Two groups classified according to the stent procedure method were compared for demographic, procedural, and postprocedure factors. Survival analysis for patency loss and overall survival was also conducted.ResultsA total of 236 subjects were included. A superior technical success rate was found in the unilateral stent group (98.8% vs. 82.5%, P < 0.001), whereas the clinical success rate was higher in the bilateral group (85.7% vs. 70.5%, P = 0.028). There was no significant difference with respect to complications or patency loss, and the bilateral group had better overall survival (P < 0.01). In the Cox proportional hazard model, MHBSs from lymph node compression were associated with a higher risk of death (HR = 9.803, P = 0.003). In contrast, bilateral SEMS insertion showed reduced postprocedural mortality (HR = 0.316, P = 0.001).ConclusionsY-type stent-in-stent bilateral SEMSs are technically difficult but demonstrated more favorable overall survival for palliative bile drainage of inoperable MHBS patients compared to unilateral insertions.     

内镜支架引流治疗肝细胞肝癌所致肝门部胆管恶性梗阻的疗效分析

目的　评估无法手术切除的肝细胞肝癌所致肝门部胆管恶性梗阻患者的内镜支架引流疗效。方法　回顾性分析2012年1月—2019年1月在海军军医大学第三附属医院因无法手术切除的肝细胞肝癌导致肝门部胆管恶性梗阻而行内镜支架引流的106例患者的临床资料。根据置入支架类型的不同,分为金属支架组（30例）和塑料支架组（76例）。观察指标包括临床成功率、并发症发生率、支架通畅期及总体生存时间。采用多因素Cox回归模型分析患者支架通畅期和总体生存时间的独立预测因素。结果　患者的总体临床成功率为67.9%（72/106）,术后胆管炎发生率为29.2%（31/106）。金属支架组与塑料支架组的临床成功率分别为93.3%（28/30）和57.9%（44/76） （χ2=12.40,P<0.001）,术后胆管炎发生率分别为13.3%（4/30）和35.5% （27/76）（χ2=5.12,P=0.024）。中位支架通畅期为5.2（95%CI：3.7~6.0）个月,中位总体生存时间为3.0（95%CI：2.5~3.7）个月。多因素Cox回归分析显示肝脏引流体积<30%是支架通畅期的独立预测因素（HR=2.12, 95%CI：1.01~4.46,P=0.048）。BismuthⅣ型（HR=2.06, 95%CI：1.12~3.77,P=0.020）、Child⁃Pugh C级（HR=4.09, 95%CI：2.00~8.39,P<0.001）、塑料支架（HR=1.87,95%CI：1.21~2.90,P=0.005）是总体生存时间的独立预测因素。结论　肝细胞肝癌一旦累及肝门部胆管预后不良。与塑料支架相比,金属支架引流在临床成功率、术后胆管炎发生率方面均具有一定优势。肝脏引流体积<30%是支架通畅期的独立预测因素,而Bismuth Ⅳ型、Child⁃Pugh C级、塑料支架为总体生存时间的独立预测因素。     

Combination of endoscopic retrograde cholangiopancreatography and endoscopic ultrasonography‐guided biliary drainage in malignant hilar biliary obstruction

Adequate biliary drainage (BD), defined as more than 50% of liver volume drained, is an ideal BD method in patients with advanced and unresectable malignant hilar biliary obstruction (MHBO). Endoscopic retrograde cholangiopancreatography (ERCP) with multi‐segmental BD is technically challenging. ERCP with percutaneous biliary drainage (PTBD) or PTBD alone has cumbersome maintenance of PTBD line and external bag. The utility of EUS‐guided BD (EUS‐BD) has risen significantly over last 5 years mostly in the clinical setting of distal bile duct obstruction. Information on EUS‐BD for malignant hilar biliary obstruction (MHBO) is thus far limited to only two small studies. This review suggests a new concept of a combination of ERCP and EUS‐BD (CERES) for BD in MHBO as a primary BD method whereby ERCP with a single self‐expandable metal stent (SEMS) is placed into either the right or the left intrahepatic bile duct (IHD). If SEMS is placed in the right biliary system, EUS‐guided hepaticogastrostomy (EUS‐HGS) can subsequently be carried out. However, if the stent is placed into the left biliary system, EUS‐guided hepaticoduodenostomy (EUS‐HDS) is done. For MHBO with non‐functioning right lobe of the liver, EUS‐HGS is carried out after failed ERCP, or primary HGS can be carried out in the left lobe of liver. For MHBO with non‐functioning left lobe of the liver, EUS‐HDS is carried out after failed transpapillary stenting of the right lobe by ERCP. Based on our experience, CERES is promising as it can fulfil gaps of both PTBD and ERCP by allowing internal drainage that can circumvent the inconvenience associated with PTBD and offer higher technical success rate compared to ERCP with bilateral SEMS placement.     

经内镜鼻胆管引流术与经内镜胆道支架置入术在低位恶性梗阻性黄疸术前胆道引流效果比较的Meta分析

目的比较经内镜鼻胆管引流术(ENBD)和经内镜胆道支架置入术(EBS)在低位恶性梗阻性黄疸术前胆道引流中的有效性及安全性。方法在中英文数据库中检索从建库至2020年8月发表的有关ENBD与EBS在低位恶性梗阻性黄疸术前胆道引流疗效对照研究的所有中英文文献,对纳入的研究进行质量评价和数据提取后,采用RevMan 5.3软件进行Meta分析,比较ENBD与EBS术前胆管炎发生率、术前胰腺炎发生率、支架障碍率、术前术后总并发症发生率、术后胰漏率的差异。结果最终纳入6项研究,包括1182例患者。Meta分析结果显示,在术前胰腺炎发生率、支架障碍率、术前术后总并发症发生率方面,ENBD组与EBS组比较差异均无统计学意义(OR分别为0.66、1.14、0.69,95%CI分别为0.44~0.99、0.56~2.31、0.41~1.15,P值分别为0.05、0.72、0.15)。但是,ENBD组相较于EBS降低了术前胆管炎发生率和术后胰漏率,差异均有统计学意义(OR分别为0.34、0.53,95%CI分别为0.23~0.50、0.32~0.88,P值分别为<0.00001、0.01)。结论对于诊断明确的低位恶性胆道梗阻患者,术前胆道引流使用ENBD优于使用EBS。未来需要更多的多中心大样本随机对照试验来验证这一结论。     

Influence of cholangitis after preoperative endoscopic biliary drainage on postoperative pancreatic fistula in patients with middle and lower malignant biliary strictures

Background and Aim

Preoperative cholangitis after preoperative drainage has been reported to increase postoperative complications, particularly pancreatic fistula. We therefore examined the effects of cholangitis after preoperative endoscopic biliary drainage (EBD) on postoperative pancreatic fistula in patients with middle and lower malignant biliary strictures.

Methods

The study group comprised 102 patients who underwent EBD among patients who underwent surgery.

Results

Of the 102 patients, 33 (32%) had postoperative pancreatic fistulas, and 56 (55%) had preoperative cholangitis after preoperative drainage. Analysis of risk factors for preoperative cholangitis showed that a total bilirubin level of 2.9 mg/dL or higher (hazard ratio [HR], 2.95; 95% confidence interval [CI], 1.223–7.130; P = 0.016) and a surgical waiting time of 29 days or longer (HR, 4.23; 95% CI, 1.681–10.637; P = 0.02) were independent risk factors for cholangitis. Patients with preoperative cholangitis had a significantly higher incidence of pancreatic fistula than did patients without preoperative cholangitis (78.8 vs 21.2%; P = 0.001). Patients with biliary cancer had a significantly higher incidence of pancreatic fistula than did those with pancreatic cancer (72.7 vs 27.2%; P = 0.005). Multivariate analysis showed that preoperative cholangitis (HR, 4.8; 95% CI, 1.785–12.992; P = 0.001) and biliary cancer (HR, 3.5; 95% CI, 1.335–8.942; P = 0.006) were significant independent risk factors for postoperative pancreatic fistula.

Conclusion

Prevention of preoperative cholangitis, a risk factor for postoperative pancreatic fistula, is likely to decrease the incidence of postoperative pancreatic fistula.     

内镜下双侧金属支架与单侧金属支架治疗不能手术切除肝门胆管恶性梗阻的比较：一项大型回顾性研究

目的:比较内镜下双侧金属支架和单侧金属支架治疗不能手术切除肝门胆管恶性梗阻的疗效优劣。方法:回顾性纳入2012年1月—2018年12月在上海东方肝胆外科医院内镜中心采用内镜下金属支架治疗的300例肝门胆管恶性狭窄(BismuthⅡ～Ⅳ型)患者资料,通过倾向性评分匹配法,94例双侧金属支架患者(双侧金属支架组)和94例单...     

Long-term outcome in patients with benign biliary strictures treated endoscopically with multiple stents

BACKGROUND: The long-term efficacy of sequential insertion of multiple plastic stents for benign biliary strictures is poorly defined. The aims of this study were to evaluate the long-term outcome (bile duct patency, complications) of this therapy and to identify predictors of a good outcome. METHODS: Retrospective review of 29 cases of benign biliary strictures treated with sequential plastic stent insertion in progressively increasing numbers and/or of increasing diameter. RESULTS: Stricture etiology was as follows: postoperative 19 (66%), chronic pancreatitis 9 (31%), and idiopathic 1 (3%). Therapy succeeded in 18 patients (62%) (mean follow-up 48.0 [11.56] months after stent removal). Therapy failed in 11 patients (38%) (mean interval to failure 11.59 [9.79] months after stent removal). The 2 groups of patients in which therapy failed had either a hilar stricture (n = 4, 25% success) or distal common bile duct stricture caused by chronic pancreatitis (n = 9, 44% success). In the remaining cases, therapy succeeded in 13 of 16 (81% success). The observed differences in success rate among subgroups were not statistically significant. There were no ERCP-related deaths. One episode of mild pancreatitis and 2 episodes of cholangitis developed during 126 ERCPs over a period of stent insertion of 36 patient years. CONCLUSIONS: In selected patients with benign biliary strictures, sequential endoscopic insertion of multiple biliary stents may lead to long-term success that could be equal to or superior to surgery with minimal morbidity. Hilar strictures and those caused by chronic pancreatitis appear to respond poorly to this therapy.     

Clinical significance of bile cytology via an endoscopic nasobiliary drainage tube for pathological diagnosis of malignant biliary strictures

Background/purpose

In patients in whom there is a suspicion of malignant biliary strictures, bile cytology via an endoscopic nasobiliary drainage tube (ENBD cytology) is often performed, in addition to aspirated bile cytology, brush cytology, and forceps biopsy, during the initial endoscopic retrograde cholangiopancreatography (ERCP). We aimed to reveal the significance of ENBD cytology for the pathological diagnosis of malignant biliary strictures.

Methods

We studied 214 patients with malignant biliary strictures. We performed aspirated bile cytology, brush cytology, and forceps biopsy in 93, 130, and 114 patients, respectively. ENBD cytology was performed one or more times in 79 patients. We examined the sensitivity of each sampling method, and analyzed the utility of ENBD cytology.

Results

The sensitivities of each sample acquisition method were as follows: 30% (28/93) for aspirated bile cytology, 48% (62/130) for brush cytology, 41% (47/114) for forceps biopsy, and 24% (19/79) for ENBD cytology. In 19 patients who showed positive ENBD cytology, other methods were performed in 11. Aspirated bile cytology, brush cytology, and forceps biopsy, were performed in 7, 5, and 6 patients, and the results were negative in 3 (43%), 2 (40%), and 1 (17%) patient, respectively. Three patients showed positive results only on ENBD cytology.

Conclusions

Although the sensitivity of ENBD cytology was inferior to that of the other methods used, ENBD cytology may contribute to the improvement of the total diagnostic sensitivity for malignancy.