Stents For Malignant Hilar Obstruction Research Articles

Suprapapillary placement of plastic versus metal stents for malignant biliary hilar obstructions: a multicenter, randomized trial.

The efficacy of the suprapapillary placement of inside plastic stents (iPSs) for unresectable malignant hilar biliary obstructions (MHOs) is unknown compared with that of uncovered inside metal stents (iMSs). This randomized controlled trial was designed to evaluate the outcomes of endoscopic placement of these stents for unresectable MHOs. This open-label, randomized study was conducted at 12 Japanese institutions. The enrolled patients with unresectable MHOs were allocated to iPS and iMS groups. The primary outcome was defined as the time to recurrent biliary obstruction in patients for whom the intervention was both technically and clinically successful. Among 87 enrollments, 38 patients in the iPS group and 46 patients in the iMS group were analyzed. Technical success rates were 100% (38 of 38) and 96.6% (44 of 46), respectively (P= 1.00). After transferring 1 unsuccessful iMS-group patient to the iPS group (since iPSs were deployed), the clinical success rates were 90.0% (35 of 39) for the iPS group and 88.9% (40 of 45) for the iMS group from a per-protocol analysis (P= 1.00). Among the patients with clinical success, the median times to recurrent biliary obstruction were 250 (95% confidence interval, 85-415) and 361 (95% confidence interval, 107-615) days (log-rank test, P= .34). No differences were detected in rates of adverse events. This Phase II randomized trial did not show any statistically significant difference in stent patency between suprapapillary plastic versus metal stents. Considering the potential advantages of plastic stents for malignant hilar obstruction, these findings suggest that suprapapillary plastic stents could be a viable alternative to metal stents for this condition.

Risk Factors for Early- and Late-Onset Cholecystitis after Y-Configured Metal Stent Placement in Patients with Malignant Hilar Biliary Obstruction: A Single-Center Study.

This study evaluated the prevalence and risk factors of early- (within 7 days of placement) and late-onset (after 7 days of placement) cholecystitis after Y-configured metal stent placement. Between June 2005 and August 2020, 109 patients who had been treated with Y-configured metal stents for malignant hilar obstruction were enrolled in the study. We retrospectively analyzed the potential risk factors for post-stent cholecystitis. The presence of diabetes (p = 0.042), the length of the common part of the Y-stent (p = 0.017), filling of the gallbladder with contrast medium during the procedure (p = 0.040), and tumor invasion of the cystic duct accompanied by filling the gallbladder with contrast medium during metal stent placement (p = 0.001) were identified as important risk factors. In cases of late-onset cholecystitis, stent obstruction (p = 0.004) and repeated endoscopic procedures due to stent malfunction (p = 0.024) were significant risk factors. In the multivariate logistic regression analysis, significant risk factors were the length of the common part of the Y-stent (p = 0.032) in early-onset cholecystitis and stent obstruction (p = 0.007) in late-onset cholecystitis. This study demonstrated that early-onset cholecystitis may occur in patients according to the length of the common portion of the Y-stent. In contrast, late-onset cholecystitis may occur in patients with stent obstruction.

Predictors of stent dysfunction in patients with bilateral metal stents for malignant hilar obstruction.

For unresectable hilar obstruction, restoring and maintaining biliary ductal patency are crucial for improved survival and quality of life. The endoscopic placement of stents is now a mainstay of its treatment, and bilateral stenting is effective for biliary decompression. This study aimed to determine the clinical outcomes of bilateral metal stent placement using large cell-type stents and the clinical predictors of stent dysfunction in patients with malignant hilar obstruction. We performed a retrospective analysis of patients who underwent bilateral metal stent placement using two large cell-type stents at two academic teaching hospitals between September 2017 and February 2019. The primary outcome was stent dysfunction. Secondary outcomes included predictors related to stent dysfunction and overall survival. The study included 87 patients who underwent bilateral metal stent placement for malignant hilar obstruction. Technical success and clinical success were achieved in 80 patients (92.0%) and 83 patients (95.4%), respectively. During the follow-up period (median: 201, range: 18-671 days), stent dysfunction occurred in 42 patients (48.3%), and the median stent patency was 199 days (95% confidence interval [CI]: 181-262). In univariate analysis, age, cholangitis before stent insertion, and subsequent chemotherapy were found to be associated with the cumulative risk of stent dysfunction. In multivariate analysis, cholangitis before stent insertion (hazards ratio [HR]: 2.26, 95% CI: 1.216-4.209, P = 0.010) and subsequent chemotherapy (HR: 0.250, 95% CI: 0.130-0.482, P<0.001) remained as statically significant factors associated with the cumulative risk of stent dysfunction. The median overall survival was 288 days (95% CI: 230-327). The bilateral placement of large cell-type stents for malignant hilar obstruction was effective with high technical and clinical success rates and acceptable patency. Cholangitis before stent insertion was associated with shorter patency, and subsequent chemotherapy was associated with longer stent patency.

Serial insertion of bilateral uncovered metal stents for malignant hilar obstruction using an 8 Fr biliary system: a case series of 17 consecutive patients.

Controversy exists over the need for unilateral versus bilateral stent placement in patients with malignant obstruction at the biliary hilum. Placement of bilateral uncovered self-expanding metal stent (UCSEMS) at this location is technically challenging, and generally associated with lower rates of procedural success. Serial insertion of side-by-side UCSEMS may be especially difficult when simultaneous deployment is not possible using larger stent delivery catheters. In this single-center, retrospective case series of all patients who underwent bilateral placement of uncovered Wallflex(TM) biliary stents between July 2008 and July 2014, we evaluate the feasibility, technical success, and safety of patients undergoing serial insertion of bilateral UCSEMS using the 8 Fr Wallflex(TM) biliary system for malignant hilar obstruction. A total of 17 patients were included. Primary cholangiocarcinoma, Bismuth IV, was the most common diagnosis. Mean procedure time was 54.4 minutes. Overall procedural technical success was achieved in 17/17 patients. Stricture dilation was necessary prior to Wallflex(TM) insertion in 8/17 patients (47.1%). Transpapillary extension of two stents was performed in all patients. There were no cases of stent deployment malfunction, or inability to insert or deploy the 2(nd) stent. Nine of 17 patients (52.9%) required inpatient hospitalization following ERCP; the most common indications were abdominal pain and need for IV antibiotics. There was one case of ERCP-related cholangitis otherwise; there were no other major complications. Bilateral, serial insertion of UCSEMS using the 8 Fr Wallflex(TM) biliary system in malignant hilar obstruction is feasible with an excellent technical success profile. Using this device for side-by-side deployment of UCSEMS appears to be safe in the majority of patients.

Bilateral metallic stenting in malignant hilar obstruction.

Endoscopic palliative biliary drainage is considered as a gold standard treatment in advanced or inoperable hilar cholangiocarcinoma. Also, metal stents are preferred over plastic stents in patients with >3 months life expectancy. However, the endoscopic intervention of advanced hilar obstruction is often more challenging and complex than that of distal malignant biliary obstructions. In this literature review, we describe the issues commonly encountered during endoscopic unilateral (single) versus bilateral (multiple) biliary stenting for malignant hilar obstruction. Also, we provide technical guidance to improve the technical success rates and patient outcomes, focusing on bilateral metallic stenting techniques such as stent-in-stent or side-by-side deployment.

Bilateral and unilateral stenting for malignant hilar obstruction: A systematic review and meta-analysis

Stents are used for palliating inoperable malignant bile duct hilar obstruction. It is not clear if bilateral stenting provides any advantage over unilateral stenting in these patients. Compare bilateral and unilateral stenting in malignant hilar obstruction. Studies using stents for palliation in patients with malignant hilar obstruction were selected. Articles were searched in MEDLINE, PubMed, Ovid journals, CINAH, International Pharmaceutical Abstracts, OLDMEDLINE, MEDLINE nonindexed citations, and Cochrane Central Register of Controlled Trials and Database of Systematic Reviews. Two reviewers independently searched and extracted data. Any differences were resolved by mutual agreement. Pooled proportions were calculated using both the Mantel-Haenszel method (fixed effects model) and DerSimonian-Laird method (random effects model). The heterogeneity among studies was tested using Cochran's Q test based upon inverse variance weights. The initial search identified 1,640 reference articles, of which 169 were selected and reviewed. Thirteen studies (n = 340) for bilateral metallic stents, eight studies (n = 575) for unilateral metallic stents, eight studies (n = 367) for bilateral plastic stenting, and seven studies (n = 850) for unilateral plastic stenting which met the inclusion criteria were included in this analysis. Pooled data are shown in Tables1 and 2. The pooled estimates by the fixed and random effect models were similar. The p for chi-squared heterogeneity for all the pooled accuracy estimates was >0.10. Bilateral metal stenting seems to have lower odds of overall complications when compared to unilateral metallic stenting. Bilateral metal stents seem to have higher odds of lowering bilirubin than unilateral metal stents, but the 30-day mortality was no different. For metal stents, bilateral metal stents are superior in palliating symptoms due to hyperbilirubinemia. Unilateral plastic stenting seems to have similar odds of overall complications, cholangitis, and 30-day mortality when compared to bilateral plastic stenting for malignant hilar strictures. In patients with malignant hilar stricture, unilateral plastic stenting is comparable to bilateral plastic stenting for adverse events.

Bilateral Metal Stents for Hilar Biliary Obstruction Using a 6Fr Delivery System: Outcomes Following Bilateral and Side-by-Side Stent Deployment

Controversy exists on optimal endoscopic management for palliation of malignant hilar obstruction, with advocates for metal "side-by-side" (SBS) and "stent-in-stent" (SIS) techniques. We sought to evaluate the technical feasibility, efficacy, and outcomes of bilateral biliary self-expanding metal stents (SEMS) for treatment of malignant hilar obstruction using a stent with a 6Fr delivery system. This was a single-center, retrospective review of all patients who underwent bilateral placement of Zilver® biliary SEMS for malignant hilar obstruction from January 2010 to August 2012. Patients underwent endoscopic retrograde cholangiopancreatography with placement of stents using either the SIS or SBS stent techniques. Twenty-four patients (19 men, mean age 63 years) underwent bilateral stenting for malignant hilar obstruction during the study period. Seventeen and seven patients underwent the SBS and SIS technique, respectively. Cholangiocarcinoma (n=14) was the most common cause of hilar obstruction. Initial technical success was achieved in 24/24 (100%) of patients; however, 12 (50%) patients required re-intervention during the study period (median 98 days). Comparison of the SBS and SIS groups revealed no statistical difference with respect to need for re-intervention (P=0.31), successful re-intervention (P=0.60), or procedural length (P=0.89). Use of bilateral Zilver® SEMS in either the SBS or SIS configuration is safe, technically feasible, and effective for drainage of malignant hilar obstruction; however, duration of stent patency and procedure-free survival remain variable.

Endoscopic bilateral metallic stenting for malignant hilar obstruction using newly designed stents

Whether unilateral or bilateral drainage should be performed for malignant hilar biliary obstruction is controversial. Moreover, endoscopic placement of bilateral metallic stents is difficult and complicated. New metallic stents, such as the Niti-S Y-type stent (Y-stent), BONASTENT M-Hilar, and Niti-S large cell D-type stent (LCD), have recently been developed for bilateral stent-in-stent procedures to facilitate contralateral stent deployment through the interstices of the first metallic stent. We review the features and efficacy of these metallic stents designed for bilateral drainage in patients with hilar biliary obstruction. The newly designed stents examined exhibited high technical success rates, low stent-related complications, and good stent patency. Endoscopic reinterventions for occluded stents could be performed easily, particularly in patients with bilateral LCD placement. Endoscopic bilateral stenting using newly designed metallic stents is feasible, safe, and effective in patients with unresectable malignant hilar biliary obstruction.

Sa1508 Techniques for Bilateral Self-Expanding Metal Stent (SEMS) Placement for the Palliation of Malignant Hilar Obstruction: A Single Center Experience

Bilateral stenting for malignant hilar obstruction remains challenging. Advancing introducers alongside an expanded SEMS can be difficult or impossible. Recent advances permit small diameter (6-7F) introducers for 8-10mm SEMS. A 6F introducer (Zilver 635®, Cook Endoscopy) allows tandem advancement of two introducers through a standard working channel (4.2mm). We report our experience with simultaneous or sequential bilateral SEMS placement at a tertiary referral center.

M2064 Are Unilateral Metallic Stents Better Than Unilateral Plastic Stents for Malignant Hilar Obstruction? a Meta-Analysis and Systematic Review of Risks

M2064 Are Unilateral Metallic Stents Better Than Unilateral Plastic Stents for Malignant Hilar Obstruction? a Meta-Analysis and Systematic Review of Risks

Unilateral vs Bilateral Metallic Stents for Malignant Hilar Obstruction: A Meta-Analysis and Systematic Review of Risks

Unilateral vs Bilateral Metallic Stents for Malignant Hilar Obstruction: A Meta-Analysis and Systematic Review of Risks

Unilateral placement of metallic stents for malignant hilar obstruction: A prospective study

Background: Palliation of patients with malignant hilar stenoses, especially advanced lesions, by stent insertion poses particular difficulties. This study assessed the efficacy of endoscopically inserted unilateral metallic stents for complex malignant hilar obstruction. Methods: A prospective, uncontrolled, single-center study was conducted by using a cohort of 61 patients with malignant hilar obstruction. A single, unilateral metallic stent was inserted across the stricture into the duct that technically was easiest to access. Patients were evaluated 1 month after stent placement and, thereafter, every 3 months. Results: Successful stent insertion was achieved in 59 of 61 (96.7%) patients. In 3 of 61 (4.9%) cases, stent malfunction occurred. Successful drainage was achieved in 59 of 61 (96.7%) patients and complete resolution of jaundice in 86% of cases. Early complications included cholangitis in 3 of 61 (4.9%) patients and stent occlusion in 2 of 61 (3.2%). Late stent occlusion occurred in 14 of 61 (22.9%) patients, including 10 (16.3%) cases of cholangitis and one of liver abscess. Median stent patency was 169 days. Median patient survival was 140 days. Conclusions: Unilateral metallic stent insertion is safe, feasible, and achieves adequate drainage in the great majority of patients with nonresectable hilar cholangiocarcinoma. (Gastrointest Endosc 2003;58:50-3.)