Efficacy of Different Types of Self-expandable Stents in Carotid Artery Stenting for Carotid Bifurcation Stenosis

Both open and closed loop self-expandable stents were used in carotid artery stenting（CAS） for carotid bifurcation stenosis. We sought to compare the efficacy of two types of stents in CAS. The data of 212 patients treated with CAS（42 and 170 cases implanted with closed and open loop stents, respectively） for carotid bifurcation stenosis and distal filtration protection devices were retrospectively analyzed. Between closed and open loop stents, there were no significant differences in hospitalization duration, NIHSS score before and after the treatment, stenosis at 12 th month, and cumulative incidence of primary endpoint events within 30 days or from the 31 st day to the 12 th month; while there were significant differences in hemodynamic changes and rate of difficulty in recycling distal filtration protection devices. Use of open vs. closed loop stents for carotid bifurcation stenosis seems to be associated with similar incidence of complications, except for greater rate of hemodynamic changes and lower rate of difficulty in recycling the distal filtration protection devices.

Outcomes of colon self-expandable metal stents for malignant vs benign indications at a tertiary care center and review of literature

BACKGROUND Endoscopic placement of a self-expandable metal stent(SEMS)is a minimally invasive treatment for use in malignant and benign colonic obstruction.However,their widespread use is still limited with a nationwide analysis showing only 5.4%of patients with colon obstruction undergoing stent placement.This underutilization could be due to perceived increase risk of complications with stent placement.AIM To review long-and short-term clinical success of SEMS use for colonic obstruction at our center.METHODS We retrospectively reviewed all the patients who underwent colonic SEMS placement over aeighteen year period (August 2004 through August 2022) at our academic center. Demographicsincluding age, gender, indication (malignant and benign), technical success, clinical success,complications (perforation, stent migration), mortality, and outcomes were recorded.RESULTSSixty three patients underwent colon SEMS over an 18-year period. Fifty-five cases were formalignant indications, 8 were for benign conditions. The benign strictures included diverticulardisease stricturing (n = 4), fistula closure (n = 2), extrinsic fibroid compression (n = 1), and ischemicstricture (n = 1). Forty-three of the malignant cases were due to intrinsic obstruction from primaryor recurrent colon cancer;12 were from extrinsic compression. Fifty-four strictures occurred on theleft side, 3 occurred on the right and the rest in transverse colon. The total malignant case (n = 55)procedural success rate was 95% vs 100% for benign cases (P = 1.0, NS). Overall complication ratewas significantly higher for benign group: Four complications were observed in the malignantgroup (stent migration, restenosis) vs 2 of 8 (25%) for benign obstruction (1-perforation, 1-stentmigration) (P = 0.02). When stratifying complications of perforation and stent migration there wasno significant difference between the two groups (P = 0.14, NS).CONCLUSIONColon SEMS remains a worthwhile option for colonic obstruction related to malignancy and has ahigh procedural and clinical success rate. Benign indications for SEMS placement appear to havesimilar success to malignant. While there appears to be a higher overall complication rate inbenign cases, our study is limited by sample size. When evaluating for perforation alone theredoes not appear to be any significant difference between the two groups. SEMS placement may bea practical option for indications other that malignant obstruction. Interventional endoscopistsshould be aware and discuss the risk for complications in setting of benign conditions. Indicationsin these cases should be discussed in a multi-disciplinary fashion with colorectal surgery.

Can we predict the incidence of high-grade Clavien-Dindo complications in patients with forgotten encrusted stents undergoing endourologic management?

Objective:Ureteral stents are customarily inserted to facilitate urinary drainage,but they come with their own glitches of being forgotten and/or encrusted leading to serious consequences.The present study aimed to report the complications in patients with forgotten and encrusted stents according to the Clavien-Dindo system specific to urological procedures and identify the factors leading to high-grade(Clavien-Dindo Grade 4A or above)complications.Methods:The hospital records of patients with forgotten encrusted double-J stents over a period of 8 years were reviewed.The parameters recorded included patient demographics,indwelling time,need for percutaneous nephrostomy,hemodialysis,urine culture,blood culture,total blood counts,serum creatinine,radiologic findings,management techniques,number of surgical interventions,modified Clavien-Dindo complications,follow-up,and mortality,if any.Results:Forty patients were included in the study.The median age was 52(range 6-85)years.Of the total,25(62.5%)patients had a“significant”stent load;31(77.5%)had renal failure or acute kidney injury on presentation;19(47.5%)patients had sepsis at presentation.Among the patients presented with sepsis,11(57.9%)patients demonstrated a positive urine culture;and 7/11(63.6%)patients exhibited pan-resistant organisms.Twelve out of 40(30.0%)patients in our series developed high-grade Clavien-Dindo complications.On univariate analysis,sepsis at presentation(p=0.007),stent load(p=0.031),diabetes(p=0.023),positive urine culture(p=0.007),and stent indwelling time of more than 1 year(p=0.031)were found to be significant.On multivariate logistic regression analysis,sepsis at presentation(p=0.017)and positive urine culture(p=0.016)were significant predictors for high-grade complications.Conclusion:It is prudent to identify specific risk factors,namely sepsis at presentation and positive urine culture to triage and optimize these patients before surgical management.

Revolutionizing palliative care:Electrocautery-enhanced lumenapposing metal stents in endoscopic-ultrasound-guided biliary drainage for malignant obstructions

Patients with malignant biliary obstruction,following endoscopic retrograde cholangiopancreatography(ERCP)failure could be referred for endoscopicultrasound-guided biliary drainage through electrocautery-enhanced(ECE)lumen-apposing metal stent(LAMS)placement.However,the efficacy and safety of ECE-LAMS in this scenario have remained debatable due to minimal scientific evidence.The current confirmed 91.0%clinical success,96.7%technical success,7.3%reintervention rate,and 17.5%adverse events,following the treatment of malignant biliary obstruction with ECE-LAMS delivery.Finally,ECE-LAMS proved to be a generalizable strategy for managing biliary obstruction for patients who were excluded from ERCP.

Unveiling the potential of electrocautery-enhanced lumen-apposing metal stents in endoscopic ultrasound-guided biliary drainage

This editorial delves into Peng et al's article,published in the World Journal of Gastrointestinal Surgery.Peng et al's meta-analysis investigates the effectiveness of electrocautery-enhanced lumen-apposing metal stents(ECE-LAMS)in ultrasound-guided biliary drainage for alleviating malignant biliary obstruction.Examining 14 studies encompassing 620 participants,the research underscores a robust technical success rate of 96.7%,highlighting the efficacy of ECE-LAMS,particularly in challenging cases which have failed endoscopic retrograde cholangio pancreatography.A clinical success rate of 91.0% underscores its impact on symptom alleviation,while a reasonably tolerable adverse event rate of 17.5% is observed.However,the 7.3% re-intervention rate stresses the need for post-procedural monitoring.Subgroup analyses validate consistent outcomes,bolstering the applicability of ECE-LAMS.These findings advocate for the adoption of ECELAMS as an appropriate approach for biliary palliation,urging further exploration in real-world clinical contexts.They offer valuable insights for optimizing interventions targeting malignant biliary obstruction management.

Research on the Status Quo and Optimization of Centralized Procurement of Coronary Stents

Objective To study the impact of the first national centralized procurement of coronary stents on patients’psychology,the economy of medical institutions,and the survival and development of the coronary stents industry,and to provide suggestions on perfecting procedures to better carry out the centralized procurement of coronary stents.Methods Literature analysis was used to investigate the results of the procurement of coronary stent in a province and a hospital.Results and Conclusion The centralized procurement of coronary stents has alleviated the economic pressure of patients,but it has many problems.Therefore,this paper proposes some suggestions,such as promoting the orderly development of the coronary stent industry,improving the evaluation link of the centralized procurement of coronary stents,adopting the accurate reporting model to ensure the quality of coronary stents and improving the standardization of clinical services.

Novel re-intervention device for occluded multiple uncovered self-expandable metal stent(with video)

To the Editor:Obstructive jaundice due to unresectable malignant hilar obstruction can be treated by deployment of bilateral uncovered self-expandable metal stents(UCSEMSs),which enable longer stent patency to be obtained compared with multiple plastic stents[1-3].However,re-intervention is needed if obstructive jaundice occurs after bilateral UCSEMS deployment.During re-intervention procedures,insertion of the stent delivery system across the mesh of a UCSEMS and into the bile duct can be challenging.A novel drill dilator has recently become available in Japan(Tornus ES;Asahi Intecc,Nagoya,Japan)(Fig.1)[4].The tract is easily dilated using a clockwise rotation.We herein describe a successful re-intervention using this device for a patient with occluded bilateral UCSEMSs.

Revision of bilateral self-expandable metallic stents placed using the stent-in-stent technique for malignant hilar biliary obstruction

Background: Endoscopic biliary decompression using bilateral self-expandable metallic stent(SEMS) placed using the stent-in-stent(SIS) technique is considered favorable for unresectable malignant hilar biliary obstruction(MHBO). However, occlusion of the bilateral SIS placement is frequent and revision can be challenging. This study was performed to investigate the efficacy, the long-term patency and the appropriate approach for revision of occluded bilateral SIS placement in unresectable MHBO. Methods: From January 2011 to July 2016, thirty-eight patients with unresectable MHBO underwent revision of occluded bilateral SIS placement. Clinical data including success rates and patency of revision, were retrospectively analyzed. Results: The technical success rate of revision was 76.3%. The clinical success rate of revision was 51.7% and mean patency of revision was 49.1 days. No significant predictive factor for clinical failure of revision was observed. The cell size of SEMS was not found to have significant effects on clinical success rates or revision patency. Conclusions: Revision of occluded bilateral SIS placement for MHBO showed fair patency and clinical success rate. Revision method and cell size of SEMS were not found to influence clinical outcomes.

Self-expandable metal stents in patients with postoperative delayed gastric emptying after distal gastrectomy

AIM To investigate the efficacy and safety of endoscopic stent insertion in patients with delayed gastric emptying after gastrectomy.METHODS In this study, we prospectively collected data from patients who underwent stent placement for delayed gastric emptying(DGE) after distal gastrectomy between June 2010 and April 2017, at a tertiary referral academic center. Clinical improvement, complications, and consequences after stent insertion were analyzed.RESULTS Technical success was achieved in all patients(100%). Early symptom improvement was observed in 15 of 20 patients(75%) and clinical success was achieved in all patients. Mean follow-up period was 1178.3 ± 844.1 d and median stent maintenance period was 51 d(range 6-2114 d). During the follow-up period, inserted stents were passed spontaneously per rectum without any complications in 14 of 20 patients(70%). Symptom improvement was maintained after stent placement without the requirement of any additional intervention in 19 of 20 patients(95%).CONCLUSION Endoscopic stent placement provides prompt relief of obstructive symptoms. Thus, it can be considered an effective and safe salvage technique for post-operative DGE.

Self-expandable metal stents for malignant gastric outlet obstruction: A pooled analysis of prospective literature

AIM: To provide an overview of the clinical outcomes of self-expandable metal stent(SEMS) placement for malignant gastric outlet obstruction(MGOO).METHODS: A systematic literature search was performed in Pub Med of the literature published between January 2009 and March 2015. Only prospective studies that reported on the clinical success of stent placement for MGOO were included. The primary endpoint was clinical success,defined according to the definition used in the original article. Data were pooled and analyzed using descriptive statistics. Subgroup analyses were performed for partially covered SEMSs(PCSEMSs) and uncovered SEMSs(UCSEMSs) using Fisher's exact test.RESULTS: A total of 19 studies,including 1281 patients,were included in the final analysis. Gastric(42%) and pancreatic(37%) cancer were the main causes of MGOO. UCSEMSs were used in 76% of patients and PCSEMSs in 24%. The overall pooled technical success rate was 97.3% and the clinical success rate was 85.7%. Stent dysfunction occurred in 19.6% of patients,mainly caused by re-obstruction(12.6%) and stent migration(4.3%),and was comparable between PCSEMSs and UCSEMSs(21.2% vs 19.1%,respectively,P = 0.412). Re-obstruction was more common with UCSEMSs(14.9% vs 5.1%,P < 0.001) and stent migration was more frequent after PCSEMS placement(10.9% vs 2.2%,P < 0.001). The overall perforation rate was 1.2%. Bleeding was reported in 4.1% of patients,including major bleeding in 0.8%. The median stent patency ranged from 68 to 307 d in five studies. The median overall survival ranged from 49 to 183 d in 13 studies.CONCLUSION: The clinical outcomes in this large population showed that enteral stent placement was feasible,effective and safe. Therefore,stent placement is a valid treatment option for the palliation of MGOO.

Resolution of an esophageal leak and posterior gastric wall necrosis with esophageal self-expandable metal stents

The use of weight reduction surgeries has increased over the years with a higher proportion of these surgeries being sleeve gastrectomies,this has been associated with some complications including staple line leaks.We report a 32-year-old male who had undergone a laparoscopic gastric band surgery and subsequently a laparoscopic sleeve gastrectomy,this was complicated by both an staple line leak at the gastroesophageal junction as well as a large(> 4 cm) posterior gastric wall defect due to gastric wall necrosis. We used two co-axially inserted self-expandable stents(SEMS) in the management of this patient,5 stents were used over repeated endoscopy sessions and 20 wk. Both defects had resolved without the need for surgical intervention.This is the first reported case were SEMS are used for both a staple line leak as well as a gastric wall defect.We also review the literature on the use of SEMS in the management of leaks post weight reduction surgeries.

Evaluation of anti-migration properties of biliary covered self-expandable metal stents

AIM: To assess anti-migration potential of six biliary covered self-expandable metal stents(C-SEMSs) by using a newly designed phantom model. METHODS: In the phantom model, the stent was placed in differently sized holes in a silicone wall and retracted with a retraction robot. Resistance force to migration(RFM) was measured by a force gauge on the stent end. Radial force(RF) was measured with a RF measurement machine. Measured flare structure variables were the outer diameter, height, and taper angle of the flare(ODF, HF, and TAF, respectively). Correlations between RFM and RF or flare variables were analyzed using a linear correlated model.RESULTS: Out of the six stents, five stents were braided, the other was laser-cut. The RF and RFM of each stent were expressed as the average of five replicate measurements. For all six stents, RFM and RF decreased as the hole diameter increased. For all six stents, RFM and RF correlated strongly when the stent had not fully expanded. This correlation was not observed in the five braided stents excluding the laser cut stent. For all six stents, there was a strong correlation between RFM and TAF when the stent fully expanded. For the five braided stents, RFM after full stent expansion correlated strongly with all three stent flare structure variables(ODF, HF, and TAF). The laser-cut C-SEMS had higher RFMs than the braided C-SEMSs regardless of expansion state.CONCLUSION: RF was an important anti-migration property when the C-SEMS did not fully expand. Once fully expanded, stent flare structure variables plays an important role in anti-migration.

Incidence and risk factors of pancreatitis in obstructive jaundice patients after percutaneous placement of self-expandable metallic stents

Background:Percutaneous transhepatic biliary drainage is an alternative treatment for patients with malignant distal biliary obstruction.The aim of this study was to investigate the occurrence of pancreatitis in patients who had undergone percutaneous placement of a biliary stent and to assess the risk factors for pancreatitis and the treatment outcomes.Methods:From January 2010 to October 2016,980 patients in our hospital who underwent percutaneous placements of self-expandable metallic stents for obstructive jaundice were retrospectively analyzed.The incidence of pancreatitis and risk factors were assessed by univariate and multivariate logistic regression analysis.Therapeutics,such as somatostatin,which were also adminstrated to release the symptom and promote the restoration of normal function of pancreas,were also analyzed.Results:Pancreatitis occurred in 45(4.6%)patients.One patient died from severe acute pancreatitis.Multivariate logistic regression analysis showed that common bile duct stent placement was the only independent risk factor that related to pancreatitis(odds ratio=2.096,95%CI:1.248–5.379;P=0.002).By using somatostatin,the concentrations of serum amylase and lipase were decreased in 44 patients with pancreatitis.No major complications were found during the treatment.Conclusions:Pancreatitis is a relatively low complication of percutaneous placement of biliary stents.The common bile duct stent placement is the only independent risk factor that related to pancreatitis.In this case,the percutaneous transhepatic biliary drainage is a preferred method for treatment.Furthermore,somatostatin is a secure and efficacious method to release the symptom and promote the restoration of pancreatic function.

Self-expandable metal stents for choledocholithiasis in Billroth II gastrectomy patients

Background: Efficient ampullary intervention is essential for endoscopic retrograde cholangiopancreatography(ERCP) in patients with a prior Billroth II gastrectomy. We retrospectively evaluated the safety and effectiveness of ampullary intervention using fully covered self-expandable metal stents(FCSEMSs) for the management of common bile duct(CBD) stones in a subset of patients with a history of Billroth II gastrectomy. Methods: This retrospective analysis involved patients with a prior Billroth II gastrectomy who underwent ampullary intervention with FCSEMSs for the management of CBD stones. The factors associated with FCSEMSs placement, treatment success, and procedural complications were analyzed. Results: A group of 15 patients(10 males; median age, 78 years) underwent biliary metal stent placement for high degree of CBD angulation(6), small or flat papilla with unclear margin(5), current use of double antiplatelet agents or an anticoagulant(2), unwanted instrumentation of the cystic duct(1), and insecure position of the scope(1). Ampullary intervention with FCSEMSs was successful in all patients. After dilating the ampulla of Vater and building a durable conduit with FCSEMSs immediately, CBD stones were removed successfully from all patients in a single session. A mild post-ERCP pancreatitis occurred in one patient, who recovered without complications. Conclusion: Ampullary intervention with FCSEMSs is safe and effective for the management of CBD stones in a subset of patients with a history of Billroth II gastrectomy.

Self-expandable metallic stents for malignant biliary obstruction:Efficacy on proximal and distal tumors

瞄准：在恶意的胆汁的肿瘤的远侧、近似的苛评的治疗比较自我可扩充的金属性的 stents (他们) 的功效。方法：从 1995 年 3 月到 2004 年 6 月， 61 个病人(40 男性， 21 女性) 与恶意的胆汁的阻塞，收到了自我可扩充的金属性的斯滕特氏印模膏培植的人，回顾地被考察。stents 被一个内视镜或经皮的 transhepatic 方法插入。我们试着在门肿瘤的情况下在 T 或 Y 配置把二 stents 交给在胆汁的系统双边的肝的管阻塞。学习的终点是斯滕特氏印模膏吸藏或耐心的死亡。结果：斯滕特氏印模膏明显的吝啬的时间是 421 +/- 在近似苛评的组的 67 d (组我) 并且 168 +/- 在远侧的苛评(组 II ) 的组的 18 d。差别在在二个组之间的边线是重要的(P = 0.0567 ) 。吝啬的生存时间是 574 +/- 在组的 76 d 我和 182 +/- 在组 II 的 25 d。在二个组之间有有效差量(P = 0.0005 ) 。结论：他们培植是为 unresectable 的一个可行、辩解的方法恶意的胆汁的阻塞。在有近似的门肿瘤的病人的他们的临床的功效在有远侧的肿瘤的病人比那好。

Safety and efficacy of self-expandable metallic stents in malignant small bowel obstructions

In this report, we present 3 cases of malignant small bowel obstruction, treated with palliative care using endoscopic self-expandable metallic stent(SEMS) placement, with the aim to identify the safety and efficacy of this procedure. Baseline patient characteristics, procedure methods, procedure time, technical and clinical success rates, complications, and patient outcomes were obtained. All 3 patients had pancreatic cancer with small bowel strictures. One patient received the SEMS using colonoscopy, while the other 2 patients received SEMS placement via double balloon endoscopy using the through-the-overtube technique. The median procedure time was 104 min. The technical and clinical success rates were 100%. Post-treatment, obstructive symptoms in all patients improved, and a low-residue diet could be tolerated. All stents remained within the patients until their deaths. The median overall survival time(stent patency time) was 76 d. SEMS placement is safe and effective as a palliative treatment for malignant small bowel obstruction.

Angle of covered self-expandable metallic stents after placement is a risk factor for recurrent biliary obstruction

BACKGROUND Studies have shown that covered self-expandable metallic stents(CSEMS)with a low axial forces after placement can cause early recurrent biliary obstruction(RBO)due to precipitating sludge formation.AIM To ascertain whether the angle of CSEMS after placement is a risk factor for RBO in unresectable distal malignant biliary obstruction(MBO).METHODS Between January 2010 and March 2019,261 consecutive patients underwent selfexpandable metallic stent insertion by endoscopic retrograde cholangiopancreatography at our facility,and 87 patients were included in this study.We evaluated the risk factors for RBO,including the angle of CSEMS after placement as the primary outcome.We measured the obtuse angle of CSEMS after placement on an abdominal radiograph using the SYNAPSE PACS system.We also evaluated technical and functional success,adverse events,time to RBO(TRBO),non-RBO rate,survival time,cause of RBO,and reintervention procedure as secondary outcomes.RESULTS We divided the patients into two cohorts based on the presence or absence of RBO.The angle of CSEMS after placement(per 1°and per 10°)was evaluated using the multivariate Cox proportional hazard analysis,which was an independent risk factor for RBO in unresectable distal MBO[hazard ratio,0.97 and 0.71;95%confidence interval(CI):0.94-0.99 and 0.54-0.92;P=0.01 and 0.01,respectively].For early diagnosis of RBO,the cut-off value of the angle of CSEMS after placement using the receiver operating characteristic curve was 130°[sensitivity,50.0%;specificity 85.5%;area under the curve 0.70(95%CI:0.57-0.84)].TRBO in the<130°angle group was significantly shorter than that in the≥130°angle group(P<0.01).CONCLUSION This study suggests that the angle of the CSEMS after placement for unresectable distal MBO is a risk factor for RBO.These novel results provide pertinent information for future stent management.

Endoscopic removal and trimming of distal self-expandable metallic biliary stents

AIM:To evaluate the efficacy and safety of endoscopic removal and trimming of self-expandable metallic stents(SEMS).METHODS:All SEMS had been placed for distal biliary strictures.Twenty-seven endoscopic procedures were performed in 19 patients in whom SEMS(one uncovered and 18 covered) removal had been attempted,and 8 patients in whom stent trimming using argon plasma coagulation(APC) had been attempted at Tokyo Medical University Hospital.The APC settings were:voltage 60-80 W and gas flow at 1.5 L/min.RESULTS:The mean stent indwelling period for all patients in whom stent removal had been attempted was 113.7 ± 77.6 d(range,8-280 d).Of the 19 patients in whom removal of the SEMS had been attempted,the procedure was successful in 14(73.7%) without procedure-related adverse events.The indwelling period in the stent removable group was shorter than that in the unremovable group(94.9 ± 71.5 d vs 166.2 ± 76.2 d,P = 0.08).Stent trimming was successful for all patients with one minor adverse event consisting of self-limited hemorrhage.Trimming time ranged from 11 to 16 min.CONCLUSION:Although further investigations on larger numbers of cases are necessary to accumulate evidence,the present data suggested that stent removal and stent trimming is feasible and effective for stent-related complications.

Self-expandable metal stents for achalasia: Thinking out of the box!

Achalasia is a primary motor disorder of the esophagus diagnosed manometrically in the clinical setting of dysphagia to both solids and liquids. Currently established treatment options include pneumatic dilation, laparoscopic Heller myotomy, botulinum toxin injection performed endoscopically, oral agents that relax the lower esophageal sphincter and esophagectomy for refractory, end-stage disease. Despite their effectiveness, a significant proportion of patients eventually relapses and needs retreatment. In this setting, several new techniques are under investigation promising future enrichment of our therapeutic armamentarium for achalasic patients. Among them, peroral endoscopic myotomy and selfexpandable metal stents placed across the gastroesophageal junction represent the most encouraging modalities, as initial studies assessing their efficacy and safety indicate. This review highlights the role of selfexpandable metal stents in the management of patients with achalasia. Their possible position in the therapeutic algorithm of achalasia along with established and novel techniques is also assessed. Finally, the need for large prospective randomized trials is underlined in order to elucidate the numerous relevant issues.

Endoscopic ultrasound-guided choledochoduodenostomies with fully covered self-expandable metallic stents

AIM:To investigate the long-term outcomes of endoscopic ultrasound-guided choledochoduodenostomy(EUS-CDS) with a fully covered self-expandable metallic stent(FCSEMS).METHODS:From April 2009 to August 2010,15 patients with distal malignant biliary obstructions who were candidates for alternative techniques for biliary decompression due to a failed endoscopic retrograde cholangiopancreatography(ERCP) were included.These 15 patients consisted of 8 men and 7 women and had a median age of 61 years(range:30-91 years).The underlying causes of the distal malignant biliary obstruction were pancreatic cancer(n = 9),ampulla of Vater cancer(n = 2),renal cell carcinoma(n = 1),advanced gastric cancer(n = 1),lymphoma(n = 1),and duodenal cancer(n = 1).RESULTS:The technical success rate of EUS-CDS with an FCSEMS was 86.7%(13/15),and functional success was achieved in 100%(13/13) of those cases.In two patients,the EUS-CDS failed because an FCSEMS with a delivery device could not be passed into the common bile duct.The mean duration of stent patency was 264 d.Early adverse events developed in three patients(3/13,23.1%),including self-limited pneumoperitoneum in two patients and cholangitis requiring stent reposition in one patient.During the follow-up period(median:186 d,range:52-388 d),distal stent migration occurred in four patients(4/13,30.8%).In 3 patients,the FCSEMS could be reinserted through the existing choledochoduodenal fistula tract.CONCLUSION:EUS-CDS with an FCSEMS is technically feasible and can lead to effective palliation of distal malignant biliary obstructions after failed ERCP.