Simultaneous insertion and precise positioning of two 6-Fr inside plastic stents for malignant hilar biliary obstruction.

Palliation of malignant extrahepatic biliary obstruction with plastic versus expandable metal stents: an evidence-based approach

Malignant biliary obstruction (MBO) encompasses a variety of malignancies arising from the pancreaticobiliary system. This can be divided into malignant hilar biliary obstruction (MHBO) or malignant distal biliary obstruction (MDBO) biliary obstruction to which clinical outcomes and technical considerations of various biliary drainage methods may differ. EUS biliary drainage (EUS-BD) has been increasingly influential in the management of MBO together with other familiar biliary drainage methods such as ERCP and percutaneous transhepatic biliary drainage (PTBD). Conventionally, ERCP has always been the primary choice of endoscopic biliary drainage in both MHBO and MDBO and that PTBD or EUS-BD is used as a salvage method when ERCP fails for which current guidelines recommends PTBD, especially for MHBO. This review was able to show that with today's evidence, EUS-BD is equally efficacious and possesses a better safety profile in the management of MBO and should be on the forefront of endoscopic biliary drainage. Therefore, EUS-BD could be used either as a primary or preferred salvage biliary drainage method in these cases.

Cholecystitis After Metallic Stent Placement in Patients With Malignant Distal Biliary Obstruction

Introduction: Malignant hilar biliary obstruction is a dreaded complication of various types of cancers including pancreatic cancer, cholangiocarcinoma, gallbladder carcinoma, and hepatocellular carcinoma. Palliative endoscopic biliary drainage plays an important role in resolving jaundice and cholangitis. The optimal stenting techniques remain to be definitely decided and the necessity to drain both liver lobes in hilar tumors remains uncertain. We report a meta-analysis of studies comparing unilateral versus bilateral stenting for malignant hilar biliary obstruction. Methods: We searched Pubmed, Medline, Embase, and Cochrane for controlled studies that compared unilateral versus bilateral stenting for malignant hilar biliary obstruction. Studies were excluded if they were non-controlled or included patients with non-malignant and non-hilar obstruction. Studies selection and data extraction were done by 2 reviewers. Disagreement was solved by a third reviewer. The quality for each included study was assessed by Consort system. Heterogeneity of the studies was analyzed by Cochran’s Q statistics. Mantel Haenszel relative risk and mean difference were calculated with random effect for outcomes with significant heterogeneity; for all others the fixed effect method was used. Results: Seven studies met the inclusion criteria with a total of 634 patients. After the initial placement of stents, there was no significant difference in the occlusion rate between unilateral and bilateral stenting (odds ratio [OR]: 1.47; confidence interval [CI]: 0.68-3.19). There was moderate heterogeneity among results reported in the studies but the clinical characteristics of the patients and the method of outcome assessment were similar and did not change our inferences. A sensitivity analysis that sorted studies based on the use of metal versus plastic stents found no statistically significant difference in the occlusion rate. Therapeutic failure, defined as the lack of resolution of symptoms post stenting, was noted in 17% with unilateral stenting compared to 22% with bilateral stenting without a statistically significant difference (OR: 0.63; CI: 0.31-1.28). Bilateral stenting was associated with higher incidence of post-stenting cholangitis 22% compared to unilateral stenting 12% (OR 0.52; 95% CI 0.28-0.96). There was no evidence of publication bias among the reported outcomes. Conclusion: When compared to bilateral stenting, unilateral stenting performed for patients with malignant hilar strictures is associated with lower incidence of post-stenting cholangitis, similar success in symptom resolution and no difference in the post stenting occlusion rate. Therefore, in the majority of patients with malignant biliary obstruction, unilateral stenting provides similar outcome to bilateral stenting.

Metal stents for distal biliary malignancy: have we got you covered?

Aim:To investigate outcomes of endoscopic bilateral side-by-side placement across the papilla using 10-mm-diameter uncovered self-expandable metal stents for unresectable malignant hilar biliary obstruction.Methods:We retrospectively analyzed 23 patients who underwent endoscopic biliary uncovered self-expandable metal stent placement for unresectable malignant hilar biliary obstruction between January 2015 and September 2016 at our institution. We performed endoscopic side-by-side placement across the papilla using 10-mm-diameter longer-model uncovered self-expandable metal stents. Outcomes included the technical and functional success rates, recurrent biliary obstruction rate, time to recurrent biliary obstruction, reintervention rate, and incidence of adverse events other than recurrent biliary obstruction.Results:Of the 23 patients, 10 with malignant hilar biliary obstruction underwent endoscopic side-by-side uncovered self-expandable metal stent placement across the papilla (median age, 83 years; 6 men). The locations of malignant hilar biliary obstruction were Bismuth types II (n = 3), III (n = 3), and IV (n = 4). The median common bile duct diameter was 8 mm. The technical and functional success rates were 100% and 80%, respectively. Seven patients (70%) developed recurrent biliary obstruction because of stent occlusions, including early hemobilia in two patients and late tumor ingrowth in five patients. The median time to recurrent biliary obstruction was 66 (95% confidence interval: 29–483) days. Six patients (60%) required reintervention, and 1 (10%) underwent transcatheter arterial embolization for right hepatic arterial pseudoaneurysm. Early adverse events other than recurrent biliary obstruction occurred in four patients and late adverse event in one patient.Conclusion:Endoscopic side-by-side placement across the papilla using 10-mm-diameter uncovered self-expandable metal stents was technically feasible for unresectable malignant hilar biliary obstruction; however, it might be better to avoid this method for patients with malignant hilar biliary obstruction because of high recurrent biliary obstruction rate and shorter time to recurrent biliary obstruction.

ObjectiveTo evaluate the feasibility, safety and the effectiveness of the complex assembly of open cell nitinol stents for biliary hilar malignancy.Materials and MethodsDuring the 10 month period between January and October 2007, 26 consecutive patients with malignant biliary hilar obstruction underwent percutaneous insertion of open cell design nitinol stents. Four types of stent placement methods were used according to the patients' ductal anatomy of the hilum. We evaluated the technical feasibility of stent placement, complications, patient survival, and the duration of stent patency.ResultsBilobar biliary stent placement was conducted in 26 patients with malignant biliary obstruction-T (n = 9), Y (n = 7), crisscross (n = 6) and multiple intersecting types (n = 4). Primary technical success was obtained in 24 of 26 (93%) patients. The crushing of the 1st stent during insertion of the 2nd stent occurred in two cases. Major complications occurred in 2 of 26 patients (7.7%). One case of active bleeding from hepatic segmental artery and one case of sepsis after procedure occurred. Clinical success was achieved in 21 of 24 (87.5%) patients, who were followed for a mean of 141.5 days (range 25-354 days). The mean primary stent patency period was 191.8 days and the mean patient survival period was 299 days.ConclusionApplying an open cell stent in the biliary system is feasible, and can be effective, especially in multiple intersecting stent insertions in the hepatic hilum.

Stenting malignant hilar biliary obstruction (MHBO) is challenging due to its complex structure, and it is less effective than blockages in the distal bile duct area. Plastic stents (PSs) and metal stents (MSs) are commonly used for stenting MHBO. This study aims to compare the outcomes of PSs and MSs in MHBO patients. We conducted a search of medical databases up to March 2024. Using a fixed-effect model, we analyzed the risk ratios (RRs) of the outcomes between the PS and MS groups. We calculated the RR for clinical and technical success, reinterventions, and adverse events, as well as the hazard ratio (HR) for survival and stent patency. This analysis includes five randomized controlled trials (RCTs) that met the inclusion criteria, comprising a total of 322 patients (156 in the PS group and 166 in the MS group). Significant differences (P < .05) in favor of the MS group were found in the reinterventions (RR 1.80, 95% CI 1.07-3.04), and stent patency (HR 0.54, 95% CI 0.32-0.90). There were no significant differences (P > 0.05) between the PS and MS groups regarding technical success (RR 1.01, 95% CI 0.94-1.09), clinical success (RR 0.86, 95% CI 0.69-1.07), overall survival (HR 0.71, 95% CI 0.47-1.05), stent migration (RR 0.69, 95% CI 0.08-6.02), stent occlusion (RR1.32, 95% CI 0.97-1.81), and adverse events (RR 0.80, 95% CI 0.53-1.20). Both PS and MS are effective for managing MHBO, while MS offers greater efficacy in increased stent patency and lower reintervention rates. Key message What is already known on this topic Metal stents (MSs) and plastic stents (PSs) are used for palliative treatment of malignant hilar biliary obstruction (MHBO). MSs significantly reduced the need for reinterventions compared to PSs in patients with MHBO. What this study adds There were no significant differences between MSs and PSs in terms of technical success, clinical success, overall survival, stent migration, stent occlusion, or adverse events. How this study might affect research, practice, or policy The study's findings may prompt researchers to design more targeted studies to further investigate these specific outcomes in MHBO patients. The results encourage endoscopists to consider patient-specific factors, such as life expectancy and preference for minimizing recurrent procedures, when choosing between MSs and PSs for MHBO.

INTRODUCTION Biliary obstruction secondary to tumor infiltration of the bile duct is a very frequent complication of pancreatic cancer. Pancreatic cancer is actually responsible of jaundice in two out of three patients with malignant biliary obstruction in clinical trials.[1] In addition, obstructive jaundice is often the first clinical sign of the disease. Obstructive jaundice limits or even precludes the use of chemotherapy, both in a neoadjuvant and palliative settings. Biliary drainage becomes, therefore, one of the cornerstones in the management of patients with pancreatic cancer. Transpapillary stenting is the approach of choice for biliary drainage in patients with pancreatic cancer and obstructive jaundice. The indications of preoperative biliary stenting, as well as relevant aspects of biliary drainage in the context of unresectable pancreatic cancer (metal or plastic stents, covered or uncovered metal stents, and new alternatives for the present and the future), are discussed in the present overview. PREOPERATIVE BILIARY DRAINAGE FOR RESECTABLE PANCREATIC CANCER Preoperative biliary drainage increases complications compared with surgery without preoperative drainage.[2] Nevertheless, some patients may benefit from preoperative relief of jaundice; these include patients with untreatable pruritus, acute cholangitis, or renal dysfunction as a consequence of obstructive jaundice. In addition, patients in whom the surgical procedure is delayed due to neoadjuvant therapy, need of nutritional support in cases of high risk of malnourishment, or due to logistic issues, also require a preoperative biliary stenting. The endoscopic transpapillary approach is generally preferred for biliary drainage in this preoperative setting, but complications should not be underestimated.[2] In fact, complications such as post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis, cholangitis, or hemorrhage may preclude patients from further curative surgical resection of the tumor. In this context, the use of maneuvers aiming at reducing the risk of post-ERCP complications (e.g., rectal indomethacin or diclofenac, pancreatic duct stenting, adequate hydration, early precut in difficult cannulation or antibiotics) should be maximized. For preoperative biliary drainage, the use of self-expandable metal stents (SEMS) should be preferred over plastic stents since they are associated with significantly lower complication rate and stent dysfunction, with a similar surgical complication rate.[34] BILIARY DRAINAGE FOR UNRESECTABLE PANCREATIC CANCER Palliative surgical or endoscopic transpapillary drainage? Endoscopic and surgical biliary drainage in patients with unresectable pancreatic cancer show similar technical success rate and long-term efficacy.[5] Endoscopic biliary drainage is associated with less complications (risk ratio [RR] 0.60; 95% confidence interval [CI] 0.45–0.81), shorter hospital stay, better quality of life, and lower cost than the surgical palliative approach.[5] Based on these results, a minimally invasive transpapillary approach is preferred for biliary drainage in patients with unresectable pancreatic cancer. Transpapillary biliary stenting for unresectable pancreatic cancer Although new devices and recent development of therapeutic endoscopic ultrasound have opened new minimally invasive options for biliary drainage, endoscopic transpapillary biliary stenting continues to be the therapy of choice for obstructive jaundice in the majority of patients with unresectable pancreatic cancer. Endoscopic transpapillary stenting is feasible in >90% of the cases in experienced hands. In addition, short-term efficacy, defined as jaundice and pruritus relief, is higher than 80%.[6789] Different studies have shown however that jaundice and pruritus relief is lower in patients with very high hyperbilirubinemia (in whom symptom relief takes frequently longer), liver metastasis (due to a lesser role of common bile duct obstruction in the pathogenesis of hyperbilirubinemia) and atypical biliary obstruction.[6789] Self-expandable metal stents or plastic stents for unresectable pancreatic cancer? Both SEMS and plastic stents are commercially available for endoscopic biliary drainage. Choosing one over the other should be based on aspects such as dysfunction rate and need of reinterventions, complication rate, patient survival and cost. A large number of studies have reported on the dysfunction rate of SEMS and plastic stents in patients with malignant distal biliary obstruction. These studies have been included in a recent meta-analysis showing a lower dysfunction rate for SEMS (21.9%) compared to plastic stents (48.9%), with a relevant risk difference of 27%.[1] Time to stent dysfunction is also significantly longer for SEMS (250 ± 104 days) than for plastic stents (124 ± 104 days) (P < 0.001). This superiority of SEMS over plastic stents is associated with a lower need of reintervention rate (21.4% vs. 56.6%, risk difference 35%).[1] As with any other ERCP procedure, complications associated with endoscopic transpapillary biliary drainage in patients with unresectable pancreatic cancer include mainly pancreatitis, cholangitis, bleeding, perforation, cholecystitis, and liver abscess. The complication rate is of about 13% after both SEMS and plastic stents.[1] As mentioned above, the use of any maneuver aiming at reducing the risk of post-ERCP complications should be maximized specifically in patients with unresectable pancreatic cancer, in whom severe complications may prevent any further oncological therapy. The question of whether sphincterotomy before SEMS placement is useful to reduce the risk of post-ERCP pancreatitis is a matter of debate. The risk of pancreatitis (7%–9%), cholangitis, stent migration, and stent dysfunction appears to be similar in patients undergoing or not undergoing sphincterotomy before SEMS.[10] The risk of bleeding is significantly higher after sphincterotomy, and thus sphincterotomy before SEMS placement cannot be generally recommended.[10] New multicenter, randomized clinical trials are currently ongoing aiming at definitively answering this question. Pancreatic cancer is a disease with dismal prognosis. Survival of patients with unresectable pancreatic cancer is short. The choice of SEMS or plastic stents for biliary drainage in these patients has probably not a major impact, but a recently published meta-analysis has reported on a statistically significant longer survival after SEMS compared to plastic stent (median survival 187 d vs. 162 d, P < 0.001).[1] Finally, cost analysis in this setting is not an easy task. This is mainly due to different factors included in the cost analysis in different studies (full treatment or stent cost and number of stents exchanged). Taking this limitation into account, cost evaluation generally supports SEMS over plastic stents due to a lower full treatment cost. What is the optimal self-expandable metal stents (uncovered, partially covered or fully covered)? Similarly to what it has been described for SEMS and plastic stents, choosing among uncovered, partially covered, and fully covered stents depend on factors such as stent patency and dysfunction, as well as complications and patient survival. All these factors appear to be similar with all these SEMS, with the exception of the cause of stent dysfunction. Compared to uncovered stents, dysfunction of covered stents is more often due to sludge formation (RR 2.47; 95% CI 1.36–4.50), stent migration (RR 9.33; 95% CI 2.54–34.24), and tumor overgrowth (RR 1.76; 95% CI 1.03–3.02), but less often due to tumor ingrowth (RR 0.25; 95% CI 0.12–0.52).[11] ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY - GUIDED INTRADUCTAL ENDOSCOPIC ABLATION The development of new devices and probes to apply radiofrequency ablation (RFA) into the bile duct in patients with malignant biliary obstruction may change in the future the way obstructive jaundice is managed in patients with pancreatic cancer today. Preliminary studies have reported on the use of ERCP-guided intraductal RFA before SEMS insertion.[121314] These studies show that ERCP-guided RFA does not significantly influence stent patency, but it appears to be an independent predictor of longer survival in patients with unresectable pancreatic cancer. These promising results should encourage us to further evaluate the role of ERCP-guided RFA for malignant obstructive jaundice in large, properly designed, and multicenter clinical trials.

T-Configured Dual Stent Placement in Malignant Biliary Hilar Duct Obstructions with a Newly Designed Stent

BackgroundPatients with malignant hilar biliary obstruction typically present with painless jaundice. They commonly have perihilar cholangiocarcinoma (pCCA), but also intrahepatic cholangiocarcinoma, gallbladder cancer, and metastases to the liver hilum can present with hilar biliary obstruction. Endoscopic biliary drainage is the standard of care in most centers. Many patients develop drainage-related complications after endoscopic biliary drainage for malignant hilar biliary obstruction, in particular cholangitis, resulting in reinterventions, clinical deterioration and a high mortality rate. Primary percutaneous stenting (PPS) aims to avoid bacterial contamination and reduce drainage-related complications. The aim of this randomized controlled trial is to compare PPS with endoscopic biliary drainage in patients with unresectable malignant hilar biliary obstruction.MethodsThis multicenter phase 3 randomized controlled trial (TESLA RCT) will recruit 148 patients with unresectable malignant hilar biliary obstruction in six Dutch tertiary academic referral centers. Diagnosis of malignant hilar biliary obstruction is pathologically confirmed or determined as very likely by the multidisciplinary team. In the intervention arm, patients undergo primary percutaneous stenting with uncovered self-expandable metal stents without crossing the ampulla and without leaving an external drain. In the control arm patients undergo endoscopic biliary drainage according to international guidelines. The primary endpoint is major complications within 90 days after randomization. Secondary outcomes include technical success, reintervention rates, decrease of bilirubin levels, eligibility for palliative systemic treatment, quality of life, and overall survival.DiscussionThe multicenter TESLA RCT compares primary percutaneous stenting with endoscopic biliary drainage in patients with unresectable malignant hilar biliary obstruction. First patient was randomized on August 9, 2023.Trial registrationNetherlands Trial Register (NL-OMON53463), registered on May 12, 2023, and Clinicaltrials.gov (NCT06671418), registered on November 1, 2024.

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

Introduction: Self-expandable metal stents (SEMSs) are commonly used to relieve malignant biliary obstruction. Covered self-expandable metal stents (CSEMSs) were introduced to improve the patency of SEMSs by preventing tissue ingrowth. Unlike uncovered self-expandable metal stents (USEMSs), which are integrated into the tumor or duct wall, CSEMSs do not embed, but have an increased risk of migration. Although several retrospective studies comparing these two types of stents for malignant biliary obstruction have shown longer patency with CSEMSs, prospective, randomized trials have not been able to confirm these results. Partially covered self-expandable metal stents (PCSEMSs) has been introduced to reduce migration with advantage of CSEMSs preventing tumor ingrowth. The aim of this study was to compare stent patency and clinical outcomes between PCSEMSs and USEMSs in malignant biliary obstruction. Methods: A total of 36 patients with malignant biliary obstruction were randomly assigned to either PCSEMSs (n=16) or USEMSs (n=20) for palliation of biliary obstruction. Duration of stent patency, procedure-related adverse events and intervention for stent occlusion were evaluated. Results: The mean period of follow-up was 105.3±100.8 days for the PCSEMSs group and 180.8±123.3 days for the USEMSs group (P=0.056). Stent occlusion occurred in only 1 patient after 84 days in the PCSEMSs group and in 6 patients after a mean of 146 days in the USEMSs group (P=0.104). Cumulative stent patency estimated by the Kaplan-Meier method showed no significant difference between PCSEMSs group and USEMSs group (P=0.20). There was no procedure-related adverse event in both groups. Additionally, there was no migration of stent in the CSEMSs group. Conclusion: There was no significant difference in stent patency time between PCSEMSs and USEMSs in the palliative treatment of malignant distal biliary obstruction, although there was trend that more stent occlusion occurred in USEMSs group than PCSEMSs group. There was no migration of stent in the CSEMSs group. Further studies with large population are warranted to validate these results.

Background:Endoscopic retrograde cholangiopancreatography (ERCP) may not provide adequate drainage for patients with malignant hilar biliary obstruction (MHBO). Endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) is a salvage method for malignant distal biliary obstruction (MDBO); however, its effectiveness for MHBO remains unclear.Objectives:We aimed to evaluate the short- and long-term outcomes of EUS-HGS for MHBO.Design:This was a single-center retrospective cohort study.Methods:Unresectable patients who underwent initial EUS-HGS because of ERCP failure were recruited. Distal biliary stenosis or Bismuth types I and II–IV were defined as MDBO and MHBO, respectively. We defined EUS-HGS for MDBO as the control and analyzed the outcomes for MHBO.Results:The MDBO group (n = 208) was treated using EUS-HGS alone. In the MHBO group (n = 63), EUS-HGS alone (unilateral drainage, n = 26), EUS-HGS with bridging (EUS-HGSB, bilateral drainage, n = 21), and ERCP + EUS-HGS (bilateral drainage, n = 16) were performed. In EUS-HGS (MDBO), EUS-HGS (MHBO), EUS-HGSB, and ERCP + EUS-HGS, the technical success rates were 98.6%, 96.3%, 95.5%, and 94.1%; clinical success rates were 88.5%, 76.9%, 85.7%, and 75.0%; adverse event rates were 19.7%, 15.4%, 9.5%, and 25.0%; and non-recurrent biliary obstruction (RBO) rates at 180 days were 45.5%, 19.8%, 61.9%, and 68.4%, respectively. In multivariate analysis of the MHBO group, EUS-HGSB tended to have a lower risk of RBO (adjusted hazard ratio (aHR), 0.39; p = 0.09), and ERCP + EUS-HGS showed a significantly lower risk (aHR, 0.25; p = 0.03) compared to EUS-HGS alone (unilateral drainage).Conclusion:ERCP + EUS-HGS followed by EUS-HGSB, providing bilateral drainage, can offer preferred palliation for MHBO. These drainages may serve as potential salvage options in the management of MHBO.

Endoscopic Intraluminal Brachytherapy and Metal Stents in Malignant Hilar Biliary Obstruction: A Pilot Study