Efficacy and safety of a fully covered self expandable metal stents (CSEMS) for distal biliary neoplasia: Preliminary data of a retrospective multicenter study (original) (raw)

Efficacy and safety of fully covered self-expandable metallic stents in biliary complications after liver transplantation: A preliminary study

Liver Transplantation, 2009

After liver transplantation, the most common biliary complication is the anastomotic stricture, which is followed by biliary leakage. Studies have focused on the endoscopic treatment of biliary complications in transplanted patients with duct-to-duct reconstruction, showing a success rate of 70% to 80% after orthotopic liver transplantation and of 60% after living-related liver transplantation. Once the endoscopic approach fails, surgical treatment with a Roux-en-Y choledochojejunostomy is the sole alternative treatment. The aim of this prospective observational study was to analyze the efficacy and safety of fully covered self-expandable metallic stents for the treatment of posttransplant biliary stenosis and leaks in patients in whom conventional endoscopic retrograde cholangiopancreatography (ERCP) failed.

Tarantino I, Traina M, Barresi L, et al .Fully covered metal stents in biliary stenosis after orthotopic liver transplantation

Endoscopy

Biliary complications are a serious source of morbidity after orthotopic and living-related liver transplantation (OLT and LRLT), and a number of studies on endoscopic treatment of these complications have been published. The rate of biliary complications in transplant recipients in published series ranges from 8 % to 35 %. This complication rate is higher for LRLT than for OLT patients . The most common biliary complication is anastomotic stricture, which is followed in frequency by biliary leakage, though patients often develop more than one complication . Endoscopic treatment of biliary complications has a success rate of about 70 -80 % after OLT and of 60 % after LRLT [4]. Standard endoscopic treatment consists of endoscopic retrograde cholangiopancreatography (ERCP) with sphincterotomy plus stent placement for biliary leaks, or progressive pneumatic dilation (from 4 to 8 -10 mm) with double stent placement (10 Fr or 11.5 Fr if possible) for biliary stenosis alone. In patients requiring more than one procedure, ERCP is repeated every 3 months [4]. In a previous study, we analyzed the efficacy and safety of fully covered self-expandable metallic stents (SEMS) for the treatment of post-transplant biliary stenosis and leaks in patients in whom conventional ERCP had failed . The rationale for using covered SEMS was to improve the durability of patency. Plastic stents have limited patency and become occluded within 3 -6 months, necessitating frequent replacement and an increasing number of stents to be used. Our preliminary data showed that in patients who do not respond to standard endoscopic treatment, the placement of a fully covered SEMS may be a valid alternative to surgery . In the current study we aimed to amplify our previous experience by including more patients and a longer follow-up period, and by analyzing the efficacy of SEMS both as a first-line approach and Tarantino I et al. Fully covered SEMS for biliary stenosis … Endoscopy 2012; 44: 246-250

Use of Fully Covered Self-Expandable Stent in Biliary Complications After Liver Transplantation: A Case Series

Transplantation Proceedings, 2010

Aims. To present our case series of fully covered self-expandable metallic stents (FCSESs) placed to treat biliary stenosis after liver transplantation and leakage after failure of plastic stenting. Materials and methods. We retrospectively reviewed the courses of patients who had undergone liver transplantation with a biliary complication that was treated by an FCSES installed by endoscopic retrograde cholangiopancreatography. We evaluated the following variables: gender, age, indication for transplantation, time between transplant and diagnosis of the complication, number of plastic stents placed before the FCSES, and procedure-related complications. Results. From April 2008 to March 2010, 11 patients who had undergone a duct-to-duct anastomosis suffered posttransplant biliary stenosis or leakage with failure of endoscopic treatment using a plastic biliary stent: Namely, eight cases of stenosis and three of biliary leaks. Three patients underwent a papillotomy to place the FCSES, with no significant morbidity. No severe complications were observed after the endoscopic treatments; two patients developed mild pancreatitis; two, hyperamylasemia; and one, mild biliary sepsis. We removed the FCSES after a mean of 280 (range ϭ 173-310) days. Five patients lost the FCSES spontaneously. One patient underwent a choledocojejunostomy and two are waiting biliary surgery. Conclusion. We avoided cholangiojejunostomy in 6/9 cases (not including the two deaths). Papillotomy did not engender a greater morbidity. The spontaneous loss of the stent is a problem that need to be resolved.

Insertion of fully covered self-expanding metal stents in benign biliary diseases

Revista espanola de enfermedades digestivas : organo oficial de la Sociedad Espanola de Patologia Digestiva, 2017

Benign biliary diseases are traditionally treated using plastic stents. However, fully covered self-expanding metal stents are currently gaining acceptance for the treatment of these pathologies. To assess the effectiveness and complications associated with the placement of temporary endoscopic fully covered self-expanding metal stents for the treatment of benign biliary diseases. This was a retrospective and observational study using a prospective database from a tertiary care center from March 2012 to May 2016. Some patients that had a fully covered metal stent due to a benign biliary disease were also included. The indications, resolution, technical success rates and adverse events were documented. 31 patients were included with a total of 34 stents inserted. The indications were as follows: 8 (25%) post cholecystectomy biliary stenoses, 11 (31%) large or multiple choledocholithiasis, 3 (8.3%) biliary fistulas, 2 (6%) post-liver transplant stenoses, 2 (8.3%) papillary stenoses, 2...

Fully covered, self-expandable metal stents for first-step endoscopic treatment of biliary leaks secondary to hepato-biliary surgery: A retrospective study

Digestive and Liver Disease, 2013

Background: Fully covered self-expanding metal stents are now being used to treat benign biliary diseases. Aims: To assess the outcomes of these stents as first-step therapy in patients with biliary leaks secondary to hepato-biliary surgery. Methods: Thirty patients (56.7% males; mean age: 60.2 ± 13 years) were retrospectively evaluated. The data collected included technical and clinical success, adverse events and follow-up findings (1, 3 and 6 months). Results: Technical and clinical success rates were 100%. One early mild post-procedure pancreatitis occurred and resolved spontaneously. Three late stent distal migrations occurred, however cholangiography showed correct leak sealing in all patients. Stents were removed after a mean of 55.9 days. During follow-up no other complications occurred. Conclusion: In our experience fully covered self-expanding metal stent placement was safe and efficacious as first-step therapy for post-operative biliary leaks. However, prospective comparative studies with plastic stents are required to validate these findings.

Biliary Leak in Post-Liver-Transplant Patients: Is There Any Place for Metal Stent?

HPB Surgery, 2012

Objectives. Endoscopic management of bile leak after orthotopic liver transplant (OLT) is widely accepted. Preliminary studies demonstrated encouraging results for covered self-expandable metal stents (CSEMS) in complex bile leaks.Methods. Thirty-one patients with post-OLT bile leaks underwent endoscopic temporary placement of CSEMS (3 partially CSEMS , 18 fully CSEMS with fins and 10 fully CSEMS with flare ends) between December 2003 and December 2010. Long-term clinical success and safety were evaluated.Results. Median stent indwelling and follow-up were 89 and 1,353 days for PCSEMS, 102 and 849 for FCSEMS with fins and 98 and 203 for FCSEMS with flare ends. Clinical success was achieved in 100%, 77.8%, and 70%, respectively. Postplacement complications: cholangitis (1) and proximal migration (1), both in the FCSEMS with fins. Postremoval complications were biliary strictures requiring drainage: PCSEMS (1), FCSEMS with fins (6) and with flare ends (1). There was no significant dif...

Management of anastomotic biliary stricture after liver transplantation: metal versus plastic stent

Annals of Gastroenterology

Background Post-transplant anastomotic biliary strictures remain refractory to endoscopic therapy in a considerable number of cases. The aim of this meta-analysis was to compare fullycovered self-expandable metal and plastic stents in the management of post-transplant biliary strictures. Methods A meta-analysis was performed using a random effects model; results were expressed as odds ratio (OR) and mean standardized difference. The primary outcome was stricture resolution, while recurrence rate after stent placement, treatment time, and safety of the procedure were the secondary outcomes. Results Through a systematic literature review until October 2017, we identified 7 studies, of which 4 were randomized controlled trials. Stricture resolution was slightly higher with metal stents, with no statistical difference between the two procedures (OR 1.38, 95% confidence interval [CI] 0.60-3.15; P=0.45) and low heterogeneity (I 2 =6%). Stricture recurrence showed a non-significant trend in favor of plastic stents (OR 1.82, 95%CI 0.52-6.31, P=0.35). Endoscopic retrograde cholangiopancreatography with placement of metal stents offered a significant improvement in terms of reduced treatment time (mean standardized difference:-3.58 months, 95%CI-6.23 to-0.93; P=0.008), but with more frequent complications, although not significantly so (OR 2.34, 95%CI 0.75-7.25; P=0.14). Sensitivity analysis confirmed all the findings. Conclusion Metal stents appear to be a promising tool that can decrease treatment time, although there is still no clear evidence of their superiority over plastic stents in terms of efficacy.

Endoscopic Treatment of Anastomotic Biliary Strictures After Living Donor Liver Transplantation: Outcomes After Maximal Stent Therapy

Clinical Gastroenterology and Hepatology, 2011

Anastomotic biliary strictures (ABSs) occur in up to 15% of patients after liver transplantation (LT). The aim of this study was to compare the efficacy and safety of self-expandable metal stents (SEMS) versus multiple plastic stents (MPS). Databases were searched through April 2017. The outcome measures were technical success, stricture resolution, recurrence and complications. We synthesized the findings descriptively and performed a meta-analysis. Three randomized controlled trials and one retrospective cohort study were identified, including 179 MPS and 119 SEMS patients. Outcome data were pooled in a meta-analysis that showed an advantage of SEMS in terms of the number of ERCP procedures (mean difference: 1.69 ERCP; 95% CI, 1-2.39; P < 0.00001) and treatment days (mean difference: 40.2 days; 95% CI, 3.9-76.4; P = 0.03), with no differences in terms of ABS resolution or recurrence. Fourteen case series reported MPS outcomes and fifteen reported SEMS outcomes, including 647 and 419 patients, respectively. Based on low-quality evidence, we cannot draw any reliable conclusions on the superiority of MPS or SEMS strategies. Even though shorter treatment times and fewer ERCP procedures support the use of SEMS, whether one technique has well-defined advantages over the other remains unclear.

Multiple plastic versus fully covered metal stents for managing post-liver transplantation anastomotic biliary strictures: a metaanalysis of randomized controlled trials

Annals of Gastroenterology

Background Anastomotic biliary strictures (ABS) following liver transplantation (LT) are one of the most common complications, occurring in 4.5-32% of patients. Multiple plastic stenting (MPS) requires multiple sessions, with the associated risk, cost and patient discomfort. Fully covered selfexpandable metal stents (FC-SEMS) have increasingly been used in this setting. We performed a systematic review and meta-analysis of randomized controlled trials (RCTs), comparing the role of FC-SEMS and MPS in the treatment of ABS post-LT. Methods We conducted a bibliographic search using PubMed and EMBASE, aimed at identifying available RCTs that compared MPS to FC-SEMS in patients with ABS post LT from January 2000 to October 2017. Primary outcomes were ABS resolution and recurrence, while secondary outcomes were adverse events and number of procedures performed. Pooled estimates were calculated using random-effects models. Results Four RCTs (205 patients) were included. ABS resolution and recurrence did not differ significantly between the groups (odds ratio [OR] 1.05, 95% confidence interval [CI] 0.43-2.56, P=0.92; and OR 2.37, 95%CI 0.54-10.38, P=0.25). The same was true for adverse events (OR 0.91, 95%CI 0.84-3.48, P=0.86) and migration rate (OR 1.31, 95%CI 0.46-3.71, P=0.61). The mean number of endoscopic retrograde cholangiopancreatography procedures was lower for FC-SEMS (mean difference [MD]-2.08). Conclusions FC-SEMS and MPS had equal ABS resolution and recurrence, although there was a trend towards a higher recurrence rate in FC-SEMS that disappeared when trials with a shorter stent indwelling time were excluding. No difference was found in overall adverse events or migration rate.