Efficacy and safety of self-expandable metallic stents for management of benign gastric outlet obstruction-A prospective study.

INTRODUCTION: We aimed at evaluating the safety and efficacy of self-expandable metallic stent (SEMS) insertion for managing patients with benign gastric outlet obstruction (GOO). METHODS: This prospective interventional study included 23 patients. All consecutive treatment-naïve symptomatic patients with benign GOO were recruited. Fully covered SEMS were deployed across the stricture under fluoroscopic and endoscopic guidance. Technical success, clinical success and sustained treatment response (STR) were assessed. Technical success was defined as the successful deployment of SEMS at the desired anatomic location. Clinical success was defined as the resolution of symptoms and an increase in Gastric Outlet Obstruction Scoring System (GOOSS) of at least 1 point from the baseline score on Day 7. STR was assessed at four and eight weeks post stent removal in patients who had a response at week four. Factors associated with stent migration and non-response at week four were also assessed. RESULTS: The median age of the study population was 30 years (range 19-65 years). Males constituted 65.22%. Most patients presented with vomiting (100%) and abdominal pain (95.65%). Peptic stricture was most common etiology for GOO (60.9%) followed by tubercular (26.1%) and corrosive (13%). Most common site of obstruction was junction of first and second part of duodenum (69.57%) followed by pyloric (30.43%). Median length of stricture was 2 cm (range 1.5-4). Technical success was achieved in all 23 patients (100%). Clinical success was achieved in 21 patients (91.3%). Response at Day 28 was seen in 20 patients (86.95%). Eighteen of 20 (90%) patients who had a response at week four had STR at week four and week eight after stent removal. Stent migration occurred in five (21.7%) patients. On univariate analysis, stricture length, calibre and stent length were found to predict migration. CONCLUSIONS: Fully covered SEMS was an effective and safe management modality in patients with benign GOO. Stent migration remains a troublesome disadvantage.

Efficacy of different stent types in post-liver-transplant anastomotic biliary strictures: a systematic review and meta-analysis.

Background: Stent selection in the endoscopic management of post-liver-transplant anastomotic biliary strictures remains controversial. This systematic review and meta-analysis aimed to evaluate the potential differences between available stents. Methods: MEDLINE, Cochrane, and Scopus databases were searched until April 2023 for comparative studies evaluating stricture management using multiple plastic stents (MPS) and self-expandable metal stents (SEMS), including fully-covered (FC)- and intraductal (ID)-SEMS. The primary outcome was stricture resolution, while secondary outcomes included stricture recurrence, stent migration and adverse events. Meta-analyses were based on a random-effects model and the results were reported as odds ratios (OR) with 95% confidence intervals (CI). Subgroup analyses by type of metal stent and a cost-effectiveness analysis were also performed. Results: Nine studies (687 patients) were finally included. Considering stricture resolution, SEMS and MPS did not differ significantly (OR 0.99, 95%CI 0.48-2.01; I 2=35%). Stricture recurrence, migration rates and adverse events were also comparable (OR 1.71, 95%CI 0.87-3.38; I 2=55%, OR 0.73, 95%CI 0.32-1.68; I 2=56%, and OR 1.47, 95%CI 0.89-2.43; I 2=24%, respectively). In the subgroup analysis, stricture resolution and recurrence rates did not differ for ID-SEMS vs. MPS or FC-SEMS vs. MPS. Migration rates were lower for ID-SEMS compared to MPS (OR 0.28, 95%CI 0.11-0.70; I 2=0%), and complication rates were higher after FC-SEMS compared to MPS (OR 1.76, 95%CI 1.06-2.93; I 2=0%). Finally, ID-SEMS were the most cost-effective approach, with the lowest incremental cost-effectiveness ratio: 3447.6 £/QALY. Conclusion: Stent type did not affect stricture resolution and recurrence; however, ID-SEMS placement was the most cost-effective approach compared to the alternatives.

Secondary uncovered versus fully-covered metal stents for the management of occluded stent in unresectable distal malignant biliary obstruction.

INTRODUCTION: Self-expandable metallic stents (SEMS) have been widely placed for unresectable distal malignant biliary obstruction (UDMBO). However, the dysfunction rate is 19-40% and its treatment is controversial. We aimed asses the efficacy and safety of a secondary biliary stents (uncovered (UC) versus fully-covered (FC) stent) for the management of occluded SEMS. PATIENTS AND METHODS: Between 2015 and June 2023, 41 patients with UDMBO underwent secondary biliary stent placement as "stent-in-stent" (20 FCSEMS and 21 UCSEMS). The primary outcomes were technical and clinical success of SEMS placement. Secondary outcomes included adverse events (AEs), patency and survival. Patients were prospectively followed until death or loss of follow-up. RESULTS: Technical (100% vs 85.5%) and clinical (100% vs 95.2%) success rates were similar in FCSEMS and UCSEMS groups. The median follow-up period was 510 days (range 290-630). The median duration of stent patency of FCSEMS (220 days, IQR 137.5-442.5) was longer than UCSEMS (150 days, IQR 110-362.5) (P=0.395), although stent dysfunction within 6 months was not different between groups. Multivariate analysis indicated that sex (HR=0.909, 0.852-0.970), antitumor treatment (HR=0.248, 0.032-0.441), stent patency (HR=0.992, 0.986-0.998) and clinical success (HR=0.133, 0.026-0.690) were significant factors for overall survival. There were no remarkable differences in AEs. CONCLUSIONS: The placement of additional biliary stent using the stent-in-stent method is an effective and safe rescue treatment for patients with UDMBO and occluded stent. In addition, the use of FCSEMS compared UCSEMS has unclear benefits regarding stent patency and overall survival.

Esophageal Stent in Acute Refractory Variceal Bleeding: A Systematic Review and a Meta-Analysis.

Background: Acute esophageal variceal bleeding accounts for up to 70% of upper-gastrointestinal bleeding in cirrhotic patients. About 10-20% of patients with acute variceal bleeding have refractory bleeding that is not controlled by medical or endoscopic therapy, and this condition can be life-threatening. Balloon tamponade is a long-standing therapy which is only effective temporarily and has several complications, while transjugular intrahepatic portosystemic shunt (TIPS) and liver transplantation may not be readily available at some centers. The use of self-expandable metal stents (SEMSs) in refractory esophageal variceal bleeding has been studied for effectiveness and adverse events and has been recommended for use as a bridge to a more definitive treatment. Aim: To investigate the effectiveness and safety of SEMSs in managing refractory variceal bleeding. Methods: A systematic search of the MEDLINE, EMBASE, and Cochrane library databases was performed from inception to October 2022 using the following terms: "esophageal stent", "self-expandable metal stents", "endoscopic hemostasis", "refractory esophageal varices", and "esophageal variceal bleeding". Studies were included in the meta-analysis if they met the following criteria: (1) patients' age older than 18 and (2) a study (or case series) that has at least 10 patients in the study. Exclusion criteria included (1) non-English publications, (2) in case of overlapping cohorts, data from the most recent and/or most appropriate comprehensive report were collected. DerSimonian-Laird random-effects meta-analysis was performed using the meta package in R statistical software(version 4.2.2). Results: Twelve studies involving 225 patients with 228 stents were included in the analyses. The mean age and/or median age ranged from 49.4 to 69 years, with a male-to-female ratio of 4.4 to 1. The median follow-up period was 42 days. The mean SEMS dwell time was 9.4 days. The most common cause of acute refractory variceal bleeding in chronic liver disease patients included alcohol use followed by viral hepatitis. The pooled rate of immediate bleeding control was 91% (95% CI 82-95%, I2 = 0). The pooled rate of rebleeding was 17% (95% CI 8-32%, I2 = 69). The pooled rate of stent ulceration was 7% (95% CI 3-13%, I2 = 0), and the pooled rate of stent migration was 18% (95% CI 9-32%, I2 = 38). The pooled rate of all-cause mortality was 38% (95% CI 30-47%, I2 = 34). Conclusions: SEMSs should be primarily considered as salvage therapy when endoscopic band ligation and sclerotherapy fail and can be used as a bridge to emergent TIPS or definitive therapy, such as liver transplantation.

Impact of sarcopenia on biliary drainage during neoadjuvant therapy for pancreatic cancer.

BACKGROUND/AIMS: Since the usefulness of neoadjuvant chemo(radiation) therapy (NAT) for pancreatic cancer has been demonstrated, recurrent biliary obstruction (RBO) in patients with pancreatic cancer with a fully covered self-expandable metal stent (FCSEMS) during NAT is expected to increase. This study investigated the impact of sarcopenia on RBO in this setting. METHODS: Patients were divided into normal and low skeletal muscle index (SMI) groups and retrospectively analyzed. Patient characteristics, overall survival, time to RBO (TRBO), stent-related adverse events, and postoperative complications were compared between the two groups. A Cox proportional hazard model was used to identify the risk factors for short TRBO. RESULTS: A few significant differences were observed in patient characteristics, overall survival, stent-related adverse events, and postoperative complications between 38 patients in the normal SMI group and 17 in the low SMI group. The median TRBO was not reached in the normal SMI group and was 112 days in the low SMI group (p=0.004). In multivariate analysis, low SMI was the only risk factor for short TRBO, with a hazard ratio of 5.707 (95% confidence interval, 1.148-28.381; p=0.033). CONCLUSION: Sarcopenia was identified as an independent risk factor for RBO in patients with pancreatic cancer with FCSEMS during NAT.

Esophageal Stenting: How I Do It.

Endoscopic esophageal stent placement is an effective palliative treatment for malignant strictures and has also been successfully used for benign indications, including esophageal refractory strictures and iatrogenic leaks and perforations. Despite several decades of evolution and the wide variety of esophageal stents available to choose from, an ideal stent that is both effective and without adverse events such as stent migration, tissue ingrowth, or pressure necrosis has yet to be developed. This paper is an overview of how this evolution happened, and it also addresses the characteristics of some of the currently available stents, like their material and construction, delivery device, radial and axial force pattern, covering and size which may help to understand and avoid the occurrence of adverse events. The insertion delivery systems and techniques of placement of an esophageal self-expandable metal stent are reviewed, as well as some tips and tricks regarding placement and management of adverse events.

A colocação endoscópica de próteses esofágicas metálicas auto-expansíveis é um tratamento paliativo eficaz da estenose maligna, tendo também sido usada com sucesso em indicações benignas, como no caso de estenoses refratárias do esófago ou de perfurações e deiscências iatrogénicas. Apesar de várias décadas de evolução e não obstante existir uma grande variedade de escolha de próteses esofágicas, ainda está por desenvolver a prótese ideal que apresente simultaneamente uma eficácia elevada e uma incidência reduzida de complicações como migração, crescimento tecidular ou necrose por pressão. Este artigo fornece uma visão global de como esta evolução ocorreu e aborda as características de algumas das próteses atualmente existentes no mercado, como o seu material e tipo de construção, padrão de força axial e radial, cobertura e dimensões, que poderão ajudar a compreender e a evitar a ocorrência desses eventos adversos. São analisados os sistemas de libertação e técnicas de introdução das próteses metálicas auto-expansíveis, com alguns truques e dicas relativas à colocação das próteses e abordagem de eventos adversos.

Factors associated with patency of self-expandable metal stents in malignant biliary obstruction.

INTRODUCTION: Endoscopic self-expandable metal stent (SEMS) placement is the key endoscopic treatment for unresectable malignant biliary obstruction. The benefit of covered SEMS over uncovered SEMS remains unknown as are risk factors for SEMS dysfunction. This study aimed to determine the factors associated with patency of SEMS. METHODS: Patients with unresectable malignant biliary obstruction who underwent endoscopic SEMS placement at Ramathibodi Hospital, during January 2012 to March 2021 were included. Patient characteristics, clinical outcomes and patency of SEMS were collected. The primary outcome were stent patency and factors associated with patency of SEMS. The factors were analyzed by univariate and multivariate analyses. Median days of stent patency, median time of patient survival, rate of reintervention and complications after SEMS placement were collected. RESULTS: One hundred and fourteen patients were included. SEMS dysfunction was found in 37 patients (32.5%). Size of cancer (Hazard ratio (HR), 1.20, (95% CI 1.02, 1.40), p 0.025), presence of stones or sludge during SEMS placement (Hazard ratio (HR), 3.91, (95% CI 1.74, 8.75), p 0.001), length of SEMS, 8 cm (HR 2.96, (95% CI 1.06, 8.3), p 0.039), and total bilirubin level above 2 mg/dL at one month after SEMS placement (HR 1.14, (95% CI 1.06, 1.22), p < 0.001) were associated with SEMS dysfunction. The median stent patency was 97 days. The median patient survival was 133 days, (95% CI 75-165). The rate of reintervention was 86% in patients with SEMS dysfunction. CONCLUSION: The size of cancer, presence of stones or sludge during SEMS placement, the length of SEMS, and total bilirubin level above 2 mg/dL at 1 month after SEMS placement were associated with SEMS dysfunction. The median time of stent patency were not statistically different in each type of stent, covered stent, partially covered stent and uncovered stent. Median survival time of patients did not associate with SEMS patency or dysfunction.

Risk factors for early and late cholecystitis after covered metal stent placement for distal biliary obstruction.

BACKGROUND: Cholecystitis is a major adverse event after self-expandable metallic stent placement for distal biliary obstruction (DBO). Covered self-expandable metallic stent (CSEMS) is being increasingly used, but few studies have investigated risk factors for cholecystitis limited to CSEMS. The present study aimed to identify risk factors for cholecystitis after CSEMS. METHODS: Patients who underwent initial CSEMS placement for DBO between November 2014 and September 2021 were enrolled and followed-up until death, recurrent biliary obstruction, cholecystitis, or until March 2022. Cholecystitis within 30 days of CSEMS was defined as early cholecystitis and after 30 days as late cholecystitis. RESULTS: Cholecystitis occurred in 51 of 339 patients (15%) after CSEMS. Forty-one patients (80.4%) had early cholecystitis, and 10 (19.6%) had late cholecystitis. Multivariate logistic regression analysis revealed that the maximum diameter of the common bile duct (CBD) (per 1 mm increase) (odds ratio [OR]: 0.87; 95% confidence interval [CI]: 0.76-1.00; p = .044), gallbladder stones (OR: 3.63; 95% CI: 1.62-8.10; p = .002), and tumor involvement in the cystic duct (CD) (OR: 4.87; 95% CI: 2.16-11.00; p < .001) were significant independent risk factors associated with early cholecystitis. No significant risk factors were identified for late cholecystitis. CONCLUSIONS: A smaller CBD diameter, gallbladder stones, and tumor involvement in the CD were identified as risk factors for early cholecystitis development after CSEMS.

Efficacy and safety of covered versus uncovered self­expandable metal stents for the palliative treatment of malignant distal biliary stricture: A long­term retrospective study.

Both covered self-expandable metal stents (CSEMSs) and uncovered self-expandable metal stents (USEMSs) have been tried in the palliation of malignant distal biliary strictures by means of endoscopic retrograde cholangiopancreatography (ERCP); however, the comparison of efficacy and safety between them remains contested. To the best of our knowledge, no similar studies have assessed this in the Chinese population. In the present study, the clinical and endoscopic data of 238 patients (CSEMSs, n=55; USEMSs, n=183) with malignant distal biliary strictures from 2014 to 2019 were collected. The efficacy indicated by mean stent patency, stent patency rate, mean patient survival time and survival rate, and the safety indicated by adverse events after CSEMS or USEMS placement were retrospectively analyzed and compared. The mean stent patency time was significantly longer in the CSEMSs group than that in the USEMSs group (262.8±195.3 days vs. 169.5±155.7 days, P=0.002). The mean patient survival time was significantly longer in the CSEMSs group than that in the USEMSs group (273.9±197.6 days vs. 184.9±167.6 days, P=0.003). The stent patency rate and patient survival rate were significantly higher in the CSEMSs group than those in the USEMSs group at 6 and 12 months, but not at 1 and 3 months. There was no significant difference in stent dysfunction and adverse events between the two groups, although post-ERCP pancreatitis (PEP) occurred more frequently in the CSEMSs group than in the USEMSs group (18.1% vs. 8.8%, P=0.049). In conclusion, CSEMSs were better than USEMSs for malignant distal biliary strictures in terms of stent patency time and patient survival time as well as stent patency rate and patient survival rate in the long term (>6 months). Adverse events in the two groups occurred at a similar rate, although the incidence of PEP was higher in the CSEMSs group.

Cognitive ERCP: decision making during successful retrieval of proximally migrated biliary stent.

Video 1Cognitive ERCP: decision making during successful retrieval of proximally migrated biliary stent.

Long-term clinical outcomes of a fully covered self-expandable metal stent for refractory pancreatic strictures in symptomatic chronic pancreatitis: An 11-year follow-up study.

BACKGROUND AND AIMS: A fully covered self-expandable metal stent (FCSEMS) has recently been applied in the management of chronic pancreatitis patients with pancreatic strictures. However, related long-term effects remain unclear. This study aimed to evaluate the long-term outcomes of FCSEMS placement in chronic pancreatitis patients with refractory strictures. METHOD: We retrospectively reviewed our database for patients undergoing FCSEMS placement for refractory pancreatic strictures between September 2008 and December 2010. The main outcomes were technical, radiological, and clinical success, as well as recurrence and adverse events. RESULTS: A total of 35 patients were included. Technical success was achieved in all patients. The median FCSEMS indwelling time was 3.2 months (interquartile range [IQR], 3.0-4.9 months). Radiological success was achieved in all patients (complete, n = 2; partial, n = 33). Clinical success was achieved in 29 patients (82.9%; complete analgesic cessation, n = 19; analgesic reduction >50%, n = 11). During the median follow-up of 136 months, (IQR, 85.8-145.5 months), eight patients (22.9%) experienced recurrence. The median interval from stent removal to recurrence was 24.9 months (IQR, 11.3-30.3 months). Biliary obstruction, an early adverse event, occurred in two patients (5.7%); the late adverse event stent-induced de novo stricture was observed in 17 patients (48.6%). CONCLUSIONS: Our findings suggest that an FCSEMS is effective for relieving refractory strictures in chronic pancreatitis. However, FCSEMSs were associated with stent-induced de novo strictures in nearly half of the patients. Prospective studies are required to further evaluate the long-term efficacy and safety of FCSEMSs in chronic pancreatitis.

Efficacy and Safety of Fluoroscopy-Guided Self-Expandable Metal Stent Placement for Treatment of Malignant Colorectal Obstruction.

AIM: To investigate long-term outcomes after SEMS insertion in patients with malignant colorectal obstruction and to identify the risk factors for complications. METHODS: The data of 119 patients with malignant colorectal obstruction who received SEMS insertion between March 2014 and February 2020 were retrospectively analyzed. Patients were divided into two groups according to the intent of treatment, i.e., stenting as "bridge to surgery" (surgical group) and stenting for palliation (palliative group). Technical and clinical success rates and incidence of complications were compared between the two groups. RESULTS: The overall technical and clinical success rates were 97.5% and 96.6%, respectively. The technical and clinical success rates and complication rate were comparable between the two groups. In the palliative group, the mean stent patency time was 230 days. Patency rates were not significantly different between primary CRC and recurrent CRC. Incidence of complications was higher in the palliative group than in the surgical group. In multivariate analysis, chemotherapy before stent implantation may increase the risk of stent-related complications, whereas chemotherapy after stent implantation did not. Additionally, the factors independently associated with complications were female sex and preoperative chemotherapy. CONCLUSIONS: SEMS under fluoroscopic guidance is a safe and effective treatment for malignant colorectal obstruction. For patients with resectable CRC, stent placement can serve as a bridge to elective surgery. It is worth noting that adjuvant chemotherapy between SEMS and surgery did not increase the complications. For patients with recurrent CRC, stent placement can relieve symptoms, alleviate pain, and improve quality of life.

Palliative stenting for malignant colorectal stenosis in the elderly.

Objectives: Self-expandable metal stents are widely used for the treatment of malignant colorectal stenosis (MCS). In elderly individuals with MCS, self-expandable metal stents are often used as a palliative treatment, but prophylactic stent placement is not recommended. We investigated the efficacy and safety of self-expandable metal stents for the elderly in a palliative setting, specifically in a prophylactic setting. Methods: Elderly patients with MCS who received a palliative stent (the stent group) or palliative stoma (the stoma group) were retrospectively enrolled between April 2017 and June 2022, and the prognosis and complication rates were assessed. Additionally, patients in the stent group were divided into symptomatic and asymptomatic subgroups, and prognosis, stent patency, and complication rates were evaluated. Results: During the study period, 31 patients with a mean age of 85.4 years and 12 patients with a mean age of 82.0 years were enrolled in the stent and stoma groups, respectively. While overall survival and complication rates were comparable, the length of hospital stay was significantly shorter in the stent group. Of the 31 patients in the stent group, 16 asymptomatic patients received prophylactic stenting, which was not associated with increased complication rates. Conclusions: Palliative stents for MCS appear to be effective and safe even in the elderly, and thus, prophylactic stents can be considered for asymptomatic patients.

Safety and Efficacy of Fully Covered Self-Expandable Metal Stents for Benign Upper Gastrointestinal Strictures Beyond the Esophagus.

Background Stents utilized for pyloric, duodenal, or anastomotic malignant strictures are generally uncovered and are not retrievable. Taewoong Medical created a through-the-scope stent that is fully covered, retrievable, and can be placed beyond the esophagus for benign gastroduodenal strictures as an alternative to surgical approaches. The aim of this paper is to examine the safety and efficacy of short-term, fully covered, self-expanding metal stents (FC-SEMS) in refractory benign strictures of the pylorus, duodenum, and gastrojejunal anastomosis. Methodology This multicenter case series was conducted at four hospitals from January 2018 through December 2020. Patients presenting with benign strictures of the pylorus, duodenum, or gastrojejunal anastomosis were entered into the study. A therapeutic channel scope was utilized to place FC-SEMS to open strictures. The stents were removed a few weeks later. A four-point gastric outlet obstruction scoring system (GOOSS) was used to record improvement. Results Statistically significant improvement in GOOSS was found between the pre-procedure and the four-week follow-up. Conclusions Fully covered, retrievable metal stents appear safe and effective in the management of refractory benign pyloric, duodenal, and anastomotic strictures. This may provide a less invasive option in the management of these strictures compared to surgery.

Endoscopic Management of Biliary Strictures after Orthotopic Liver Transplantation: A Single Center Experience Study.

Background and Aim. Endoscopic therapy is the method of choice in the management of biliary strictures after orthotopic liver transplantation (OLT). Even though the mainstay approach for OLT stricture complications is represented by consecutive procedures of multiple plastic stents (MPS) insertion, a valuable alternative is the use of fully covered self-expandable metal stents (FCSEMS). The aim of the study was to compare MPS with FCSEMS used in the management of OLT biliary strictures, in terms of clinical outcomes and complications. Material and Methods. This is a retrospective, single-center study conducted between February 2014 and November 2019 in the Clinical Emergency Hospital of Bucharest, Romania. We enrolled all consecutive patients who developed biliary strictures after OLT and were treated by endoscopic retrograde cholangiopancreatography (ERCP) either with MPS or FCSEMS. Results. Thirty-six patients were included in the study, 27 patients had MPS and nine patients had FCSEMS. 106 ERCP procedures were performed and 159 stents were inserted. The mean number of ERCP procedures required per patient was significantly higher for MPS than for FCSEMS (3.34 ± 1.46 vs. 2.11 ± 0.33, p < 0.001). In the FCSEMS group only one patient had three procedures, due to stent migration. Difficult cannulation was encountered in 22 patients, 18 patients from MPS group and four patients from FCSEMS group. Dilation was performed in 20 (77%) MPS patients and in four FCSEMS patients (44%). Overall, we used 159 stents for stricture resolution, 149 plastic stents and 10 FCSEMS. Mean number of stents inserted was significantly lower in the FCSEMS group compared to MPS group (1.16 ± 0.40 vs. 5.73 ± 2.64, p < 0.001). Conclusions. Stricture resolution using FCSEMS is comparable to MPS and even has some advantages. In line with prior studies, FCSEMS are effective, with fewer complications and similar outcome compared to plastic stents. Other particular aspects should be further assessed, especially long-term follow up of FCSEMS and their cost efficiency.

Migration rate using fully covered metal stent in anastomotic strictures after liver transplantation: Results from the BASALT study group.

BACKGROUND AND STUDY AIM: The traditional endoscopic therapy of anastomotic strictures (AS) after orthotopic liver transplantation (OLT) is multiple ERCPs with the insertion of an increasing number of plastic stents side-by-side. Fully covered self-expanding metal stents (cSEMS) could be a valuable option to decrease the number of procedures needed or non-responders to plastic stents. This study aims to retrospectively analyse the results of AS endoscopic treatment by cSEMS and to identify any factors associated with its success. PATIENTS AND METHODS: Ninety-one patients (mean age 55.9 ± 7.6 SD; 73 males) from nine Italian transplantation centres, had a cSEMS positioned for post-OLT-AS between 2007 and 2017. Forty-nine (54%) patients were treated with cSEMS as a second-line treatment. RESULTS: All the procedures were successfully performed without immediate complications. After ERCP, adverse events occurred in 11% of cases (2 moderate pancreatitis and 8 cholangitis). In 49 patients (54%), cSEMSs migrated. After cSEMS removal, 46 patients (51%) needed further endoscopic (45 patients) or radiological (1 patient) treatments to solve the AS. Lastly, seven patients underwent surgery. Multivariable stepwise logistic regression showed that cSEMS migration was the only factor associated with further treatments (OR 2.6, 95% CI 1.0-6.6; p value 0.03); cSEMS implantation before 12 months from OLT was associated with stent migration (OR 5.2, 95% CI 1.7-16.0; p value 0.004). CONCLUSIONS: cSEMS appears to be a safe tool to treat AS. cSEMS migration is the main limitation to its routinary implantation and needs to be prevented, probably with the use of new generation anti-migration stents.

Comparison of outcomes between secondary fully covered and uncovered self-expandable metal stents in the treatment of recurrent biliary obstruction of pancreatic cancer.

BACKGROUND: The overall survival (OS) of pancreatic cancer (PC) has been prolonged by advances in chemotherapy, and the number of cases of recurrent biliary obstruction (RBO) after self-expandable metal stent (SEMS) placement is expected to increase. We herein compared outcomes between secondary fully covered SEMS (FC) and uncovered SEMS (UC) for RBO of PC with FC placed as the 1st SEMS. METHODS: Between May 2010 and March 2021, 62 PC patients who underwent SEMS exchange to FC (n = 34) or UC (n = 28) for RBO were retrospectively analyzed. Patient characteristics, OS, time to RBO (TRBO), and stent-related adverse events were compared between the FC and UC groups. Cox's proportional hazard model was used to identify risk factors for RBO with the 2nd SEMS. RESULTS: There was a significant difference between the FC and UC groups only in the 2nd SEMS diameter. Median OS and TRBO were 195 and 238 days in FC patients and 306 and 455 days in UC patients, respectively, with no significant differences between the two groups. No significant differences were observed in the stent-related adverse event rate. In multivariate analyses, only the 2nd SEMS diameter was significant (P = 0.009). Median TRBO were 455, 238, and 103 days in 10-mm UC, 10-mm FC, and 8-mm UC patients, with 10-mm UC patients having significantly longer TRBO than 10-mm FC and 8-mm UC patients (P = 0.020 and 0.001). CONCLUSION: SEMS exchange to 10-mm UC may be appropriate for RBO of PC with FC as the 1st SEMS.

Practical Experiences of Unsuccessful Hemostasis with Covered Self-Expandable Metal Stent Placement for Post-Endoscopic Sphincterotomy Bleeding.

We reviewed 7 patients with unsuccessful endoscopic hemostasis using covered self-expandable metal stent (CSEMS) placement for post-endoscopic sphincterotomy (ES) bleeding. ES with a medium incision was performed in 6 and with a large incision in 1 patient. All but 1 of them (86%) showed delayed bleeding, warranting second endoscopic therapies followed by CSEMS placement 1-5 days after the initial ES. Subsequent CSEMS placement did not achieve complete hemostasis in any of the patients. Lateral-side incision lines (3 or 9 o'clock) had more frequent bleeding points (71%) than oral-side incision lines (11-12 o'clock; 29%). Additional endoscopic hemostatic procedures with hemostatic forceps, hypertonic saline epinephrine, or hemoclip achieved excellent hemostasis, resulting in complete hemostasis in all patients. These experiences provide an alert: CSEMS placement is not an ultimate treatment for post-ES bleeding, despite its effectiveness. The lateral-side of the incision line, as well as the oral-most side, should be carefully examined for bleeding points, even after the CSEMS placement.

Endoscopic removal of biliary uncovered self-expandable metal stents in one patient placed 15 years ago.

Before: 51 W: We removed two biliary uncovered SEMSs from one patient using stent-in-stent technique with a fully covered biliary stent, one of which was placed for up to 15 years. That is rare and also meaningful. Maybe,we should have a new understanding of uncovered SEMS in management of benign biliary strictures. After: 50 W: Yu and colleagues removed two biliary uncovered self-expandable metal stents, one of which had been in place for 15 years, from one patient using the stent-in-stent technique with a fully covered biliary stent. A new understanding of uncovered self-expandable metal stents in the management of benign biliary strictures is needed.

Fully covered metal biliary stents: A review of the literature.

Fully covered self-expandable metal stents (FCSEMS) represent the latest advancement of metal biliary stents used to endoscopically treat a variety of obstructive biliary pathology. A large stent diameter and synthetic covering over the tubular mesh prolong stent patency and reduce risk for tissue hyperplasia and tumor ingrowth. Additionally, FCSEMS can be easily removed. All these features address issues faced by plastic and uncovered metal stents. The purpose of this paper is to comprehensively review the application of FCSEMS in benign and malignant biliary strictures, biliary leak, and post-sphincterotomy bleeding.