Fully Covered Self-expandable Metal Stents Research Articles

Effects of Clip Anchoring on Preventing Migration of Fully Covered Self-Expandable Metal Stent in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography: A Multicenter, Randomized Controlled Study.

Fully covered self-expandable metal stents (FCSEMSs) are commonly placed in patients with biliary stricture during endoscopic retrograde cholangiopancreatography (ERCP). However, up to 40% of migration has been reported, resulting in treatment failure or the requirement for further intervention. Here, we aimed to investigate the effects of metal clip anchoring on preventing the migration of FCSEMS. Consecutive patients requiring placement of FCSEMS were included in this multicenter randomized trial. The enrolled patients were randomly assigned in a 1:1 ratio to receive clip anchoring (clip group) or not (control group). The primary outcome was the migration rate at 6 months after stent insertion. The secondary outcomes were the rates of proximal and distal migration and stent-related adverse events. The analysis followed the intention-to-treat principle. From February 2020 to November 2022, 180 patients with biliary stricture were enrolled, with 90 in each group. The baseline characteristics were comparable between the 2 groups. The overall rate of stent migration at 6 months was significantly lower in the clip group compared with the control group (16.7% vs 30.0%, P = 0.030). The proximal and distal migration rates were similar in the 2 groups (2.2% vs 5.6%, P = 0.205; 14.4% vs 22.2%, P = 0.070). Notably, none of the patients (0/8) who received 2 or more clips experienced stent migration. There were no significant differences in stent-related adverse events between the 2 groups. Our data suggest that clip-assisted anchoring is an effective and safe method for preventing migration of FCSEMS without increasing the adverse events.

Magnetic Compression Anastomosis for the Treatment of Complete Biliary Obstruction After Cholecystectomy

Background & AimsPost-cholecystectomy biliary strictures can be treated surgically or non-surgically. Although endoscopic or percutaneous treatments are the preferred approaches, these methods are not feasible in cases where complete stricture occlusion prevents the successful passage of a guidewire. The utility of magnetic compression anastomosis (MCA) in patients with post-cholecystectomy complete biliary obstruction that cannot be treated conventionally was evaluated. MethodsMCA was performed in 10 patients with post-cholecystectomy biliary strictures that did not resolve with conventional endoscopic or percutaneous treatment. One magnet was delivered through the percutaneous transhepatic biliary drainage tract, and another was advanced via endoscopic retrograde cholangiopancreatography(ERCP) of the common bile duct. After magnet approximation and recanalization, a fully covered self-expandable metal stent (FCSEMS) was placed for 3 months and then replaced for a further 3 months. Stricture resolution was evaluated after FCSEMS removal. ResultsAmong the 10 patients who underwent MCA for post-cholecystectomy biliary stricture, the biliary injury was Strasberg type B in 2, type C in 3, and type E in 5. Recanalization was successful in all patients (technical success rate 100%). The mean follow-up period after recanalization was 50.2 months (range 13.2–116.8 months). Partial restenosis after MCA occurred in two patients at 24.1 and 1.6 months after stent removal. ERCP with FCSEMS placement resolved the recurrent stenosis in both patients. ConclusionsMCA is a useful alternative nonsurgical treatment for complete biliary obstruction after cholecystectomy that cannot be resolved by conventional methods.

Endoscopic treatment of bile duct stones with benign choledochojejunal anastomotic stenosis

[BACKGROUND AND AIMS]: Endoscopic interventions for bile duct stones (BDS) with benign choledochojejunal anastomotic stenosis (bCJS) are challenging. Therefore, we investigated endoscopic interventions for BDS with bCJS. [METHODS]: Seventeen patients with BDS with bCJS were retrospectively analyzed. Patient characteristics, technical success, adverse events (AEs), and recurrence were evaluated. [RESULTS]: In 17 patients, the median diameters of the bile duct and BDS were both 8 mm. The median number of BDS was 3. The technical success rate was 94% (16/17). Ten patients underwent balloon dilation at the choledochojejunal anastomotic site (CAS), the median diameter of balloon dilation was 10.5 mm, and waist disappearance was achieved in 2. Six patients had fully covered self-expandable metal stents (FCSEMS) with a diameter of 10 mm placed at the CAS. BDS were removed after balloon dilation or FCSEMS removal, and 6 out of 16 patients were treated with a combination of lithotripsy and 5 with peroral direct cholangioscopy (PDCS). Regarding AEs, perforation at the CAS by balloon dilation occurred in 1 patient. The median follow-up was 3701 days. Nine out of 16 patients (56%) had recurrence. The patients treated with combination of PDCS at BDS removal (p=0.022) and waist disappearance at the CAS by balloon dilation (p=0.035) had significantly fewer recurrences. [CONCLUSIONS]: Endoscopic interventions for BDS with bCJS are useful and relatively safe; however, long-term follow-ups showed frequent recurrences. Recurrence was common in patients not treated with the combination of PDCS at BDS removal and those without waist disappearance at the CAS by balloon dilation.

Long-term outcomes of fully covered self-expandable metal stents for refractory biliary strictures after living donor liver transplantation: a retrospective study at a tertiary center

Long-term outcomes of fully covered self-expandable metal stents for refractory biliary strictures after living donor liver transplantation: a retrospective study at a tertiary center

Outcomes of 6-mm diameter fully covered self-expandable metal stents for preoperative biliary drainage in pancreatic cancer.

10-mm self-expandable metal stents (SEMSs) are commonly used for preoperative biliary drainage in pancreatic cancer. However, smaller diameter SEMSs have attracted attention with the attempt to reduce stent-related adverse events (AEs). We retrospectively analyzed consecutive borderline resectable pancreatic cancer patients who underwent neoadjuvant therapy and fully covered SEMS (FCSEMS) placement from April 2015 to May 2023. The primary outcome was stent-related non-event rate (NER), which was defined as the rate of completion of surgery without developing any preoperative events (recurrent biliary obstruction [RBO] or stent-related AEs). Secondary outcomes included stent-related AEs, causes of RBO, and cumulative incidence of RBO. Risk factors for pancreatitis, RBO, and stent migration were also examined. A total of 76 patients were included (6-mm group: 23; 10-mm group: 53). Stent-related NER (57% vs. 64%, p = 0.610), stent-related AEs (4% vs. 15%, p = 0.263), overall RBO rates (39% vs. 23%, p = 0.168), cumulative incidence of RBO (hazard ratio, 2.24; 95% confidence interval, 0.95-5.25; p = 0.065) were not significantly different between the two groups. Tumor involvement of the pancreatic duct was identified as a risk-reducing factor for pancreatitis, while an FCSEMS diameter of 6 mm was not identified as a risk factor for RBO and stent migration. Stent-related NER was not significantly affected by FCSEMS diameter. Further studies are needed to confirm the usefulness of 6-mm diameter FCSEMS for preoperative biliary drainagein patients with borderline resectable pancreatic cancer.

Safety of biliary drainage with 6-mm metallic stent for preoperative obstructive jaundice in pancreatic cancer: PURPLE SIX STUDY.

The 10-mm self-expandable metal stent (SEMS) is the standard for endoscopic transpapillary biliary drainage before pancreatic cancer surgery. However, the efficacy of stents thinner than 10mm has not been adequately validated. Therefore, we aimed to evaluate the safety of a 6-mm fully covered SEMS (FCSEMS) for distal malignant biliary obstruction (DMBO) during preoperative chemotherapy for pancreatic cancer. This was a single-arm, multicenter, prospective phase II study of endoscopic transpapillary initial biliary drainage for DMBO before pancreatic cancer surgery. The primary endpoint was stent-related adverse events, and the key secondary endpoint was the non-recurrent biliary obstruction (non-RBO) rate during the observation period for both resectable (R) and borderline resectable (BR) pancreatic cancers. The study enrolled 33 patients, among whom 32 received the study treatment. There were 23 and 9 cases of R and BR pancreatic cancers, respectively. The technical and clinical success rates were 97.0% and 90.1%, respectively. The stent-related adverse event rate was 3.1% (n=1, acute pancreatitis) (95% confidential interval, 0.00-16.2), which met the criteria to be considered safe. The overall non-RBO rate during the observation period (median 96days) was 78.1% (82.6% and 66.7% for R and BR pancreatic cancer cases, respectively). The 6-mm FCSEMS is an extremely safe metallic stent with a low stent-related adverse event rate of 3.1% for preoperative biliary drainage in pancreatic cancer. It is considered the optimal stent for preoperative biliary drainage in terms of the non-RBO rate. UMIN Clinical Trial Registry (UMIN-CTR 000041704).

A Short Fully Covered Self-Expandable Metal Stent for Management of Benign Biliary Stricture Not Caused by Living-Donor Liver Transplantation.

Background: This study evaluated the effectiveness of short fully covered self-expanding metal stents (FCSEMS) with an anti-migration design in treating benign biliary strictures (BBS) not related to living donor liver transplantation (LDLT). Methods: A retrospective analysis was conducted on 75 patients who underwent FCSEMS insertion for BBS management. Stents were initially kept for 3 months and exchanged every 3 months until stricture resolution. Adverse events and stricture recurrence after FCSEMS removal were assessed during follow-up. Results: The study outcomes were technical success, stenosis resolution, and treatment failure. Technical success was 100%, with stricture resolution in 99% of patients. The mean onset time of BBS post-surgery was 4.4 years, with an average stent indwelling period of 5.5 months. Stricture recurrence occurred in 20% of patients, mostly approximately 18.8 months after stent removal. Early cholangitis and stent migration were noted in 3% and 4% of patients, respectively. Conclusions: This study concludes that short FCSEMS demonstrate high efficacy in the treatment of non-LDLT-related BBS, with a low incidence of interventions and complications. Although this is a single-center, retrospective study with a limited sample size, the findings provide preliminary evidence supporting the use of short FCSEMS as a primary treatment modality for BBS. To substantiate these findings, further research involving multicenter studies is recommended to provide additional validation and a broader perspective.

Multisegmented esophageal fully covered self-expandable metal stent for palliation of malignant dysphagia: a prospective, multicenter feasibility and safety study

A novel multisegmented esophageal fully covered self-expandable metal stent (FCSEMS) was designed to reduce stent migration, which is seen in up to 30% of patients. The goal of this study was to evaluate the safety and efficacy of the multisegmented FCSEMS. This multicenter prospective study aimed to include 30 patients undergoing palliative stent placement. Efficacy, defined as technically successful stent placement and dysphagia scores, and safety, defined as the number of adverse events (AEs) and serious AEs (SAEs), were measured. The study was prematurely terminated due to safety concerns after including 23 patients (mean ± standard deviation age, 72 ± 10 years; 78% male). Stent placement was technically successful in 21 patients (91%), and dysphagia scores had improved in all patients with successful stent placement. SAEs were reported in 16 (70%) patients. Stent-related mortality occurred in 3 patients (13%). The multisegmented FCSEMS successfully treated malignant dysphagia. The study was prematurely terminated, however, because stent placement was associated with a relatively high SAE rate. (Clinical trial registration number: NCT04415463.).

Pancreatic Pseudocyst after Fully Covered Self-expandable Metallic Stent Placement: A Case Report.

A 70-year-old woman presented with stage III pancreatic head cancer. After endoscopic sphincterotomy, a fully covered self-expandable metallic stent (FCSEMS) was placed in the common bile duct to manage jaundice. The patient developed a fever and abdominal pain 40 days after stent placement, with a suspected diagnosis of infected pancreatic pseudocyst. Purulent discharge from the papilla was observed during FCSEMS removal, and pancreatography revealed a pseudocyst connected to the main pancreatic duct. The pancreatic pseudocyst resolved after transpapillary drainage. Pancreatic pseudocysts should be suspected after biliary FCSEMS placement, and prompt removal and endoscopic drainage of the FCSEMS should be considered.

Study protocol for a prospective, multicentre, phase II trial on endoscopic treatment using two fully covered self-expandable metallic stents for benign strictures after hepaticojejunostomy

IntroductionThe current endoscopic treatment for postoperative benign hepaticojejunostomy anastomotic stricture (HJAS) has a high technical success rate and is highly effective in the short term. However, long-term results have shown...

The use of fully covered self-expandable metal stents in the endoscopic treatment of portal cavernoma cholangiopathy

Background and aimsThere are different therapeutic approaches for biliary strictures and reducing portal hypertension in patients with symptomatic portal cavernoma cholangiopathy (PCC). Endoscopic treatment includes endoscopic biliary sphincterotomy (EST), dilation of stricture with a biliary balloon, placement of plastic stent(s) and stone extraction. Fully covered self-expandable metal stent (FCSEMS) is placed as a rescuer in case of haemobilia seen after EST, dilation of stricture and removal of plastic stent rather than the stricture treatment itself. In this retrospective observational study, we sought to assess the clinical outcomes of FCSEMS as the initial treatment for PCC-related biliary strictures.Materials and methodsTwelve symptomatic patients with PCC both clinically and radiologically between July 2009 and February 2019 were examined. Magnetic resonance cholangiopancreatography (MRCP) and cholangiography were employed as the diagnostic imaging methods. Chandra–Sarin classification was used to distinguish between biliary abnormalities in terms of localization. Llop classification was used to group biliary abnormalities associated with PCC. Endoscopic partial sphincterotomy was performed in all the patients. If patients with dominant strictures 6-8-mm balloon dilation was first performed. This was followed by removal of the stones if exist. Finally, FCSEMS placed. The stents were removed 6–12 weeks later.ResultsThe mean age of the patients was 40.9 ± 10.3 years, and 91.6% of the patients were male. Majority of the patients (n = 9) were noncirrhotic. Endoscopic retrograde cholangiopancreatography (ERCP) findings showed that 11 of the 12 patients were Chandra Type I and one was Chandra Type IIIa. All the 12 patients were Llop Grade 3. All patients had biliary involvement in the form of strictures. Stent placement was successful in all patients. FCSEMSs were retained for a median period of 45 days (30–60). Seven (58.3%) patients developed acute cholecystitis. There was no occurrence of bleeding or other complications associated with FCSEMS replacement or removal. All patients were asymptomatic during median 3 years (1–10) follow up period.ConclusionsFCSEMS placement is an effective method in biliary strictures in case of PCC. Acute cholecystitis is encountered frequently after FCSEMS, but majority of patients respond to the medical treatment. Patients should be followed in terms of the relapse of biliary strictures.

Anchoring fins of fully covered self-expandable metal stents affect pull-out force and stent migration

Background and AimsStent migration and subsequent adverse events are frequently observed in the use of fully covered self-expanding metal stents (FCSEMS) for distal biliary stenosis. In this study, we aimed to identify predictors for stent migration based on biomechanical stent characteristics and to associate these findings with clinical outcomes. MethodsThe migration resistance of FCSEMS was quantified by measuring the pull-out force. We analyzed a single-center retrospective cohort of 178 FCSEMS for treatment success and adverse events occurring during 180 days of follow-up. ResultsBiomechanical measurements revealed a 4-fold higher migration resistance of FCSEMS with anchoring fins (AF, Fmax=14.2+/-0.1 N) compared to FCSEMS with flare ends (FE, Fmax=3.8+/-1.0 N, p<0.0001). Clinically, AF-FCSEMS showed lower rates of migration compared to the FE-FCSEMS (5% vs. 34%, p<0.0001). Unscheduled ERCP due to stent dysfunction was less frequent in the AF-group compared to the FE-group (15% vs. 29%, p=0.046). Cholangitis due to stent dysfunction was observed in 5% of the AF-FCSEMS compared to 19% in the FE-FCSEMS group (p=0.02). Stent patency rates at 1, 3, and 6 months were higher in the AF-group (96 %, 90%, and 80%) compared to the FE-group (90%, 74%, and 66%) (Log-rank test: p=0.03). ConclusionsThe pull-out force as biomechanical stent property predicts the migration resistance of FCSEMS in distal biliary stenosis and may thus be used to classify stents for this application. AF-FCSEMS showed a significantly lower rate of migration and adverse events compared to FE-FCSEMS.

Usefulness of Intraductal Placement of a Dumbbell-Shaped Fully Covered Self-Expandable Metal Stent for Post-Cholecystectomy Bile Leaks.

Background and aims: In the treatment of post-cholecystectomy bile leaks, endoscopic naso-biliary drainage (ENBD) or biliary stenting using plastic stents is the standard of care. Fully covered self-expandable metal stent (FCSEMS) placement across the sphincter of Oddi is considered a salvage therapy for refractory cases, but pancreatitis and migration are the major concerns. Intraductal placement of a dumbbell-shaped FCSEMS (D-SEMS) could avoid these drawbacks of FCMSESs. In this retrospective study, we investigated the usefulness of intraductal placement of the D-SEMS for post-cholecystectomy bile leaks. Methods: Six patients who underwent intraductal placement of the D-SEMS for post-cholecystectomy bile leaks were enrolled. This method was performed as initial treatment in three patients and as salvage treatment in three ENBD refractory cases. Results: Technical and clinical successes were obtained in 6 (100%) patients and 5 (83%) patients, respectively. One clinically unsuccessful patient required laparoscopic peritoneal lavage. The early adverse event was one case of mild pancreatitis (17%). The median duration of the D-SEMS indwelling was 61 days (42-606 days) with no migration cases, all of which were successfully removed. The median follow-up after index ERCP was 761 (range: 161-1392) days with no cases of recurrent bile leaks. Conclusions: Intraductal placement of the D-SEMS for post-cholecystectomy bile leaks might be safe and effective even in refractory cases.

Self-expanding metallic stent for refractory pancreatic duct stricture in chronic pancreatitis: A prospective follow-up study.

In chronic pancreatitis, fully covered self-expanding metal stents (FCSEMS) are used to treat refractory pancreatic duct strictures. However, the FCSEMS design, effectiveness, safety, optimal stent indwelling time and patient selection remain unclear. This study aimed at evaluating technical success, clinical success and adverse events with FCSEMS in patients with symptomatic pancreatic duct stricture. The prospective study was conducted between May 2017 and May 2021 at a tertiary care center for chronic pancreatitis with refractory pancreatic duct stricture using controlled radial expansion (CRE) endoscopic retrograde cholangiopancreatography (ERCP) with FCSEMS (Niti-S, Bumpy stent, Taewoong Medical, Gimpo-Si, South Korea). During the study period, a total of 11 patients underwent ERCP with FCSEMS for refractory pancreatic duct stricture. The mean age (± standard deviation, [SD]) was 32.36 ± 10.98years and nine patients (81%) were male. Technical and clinical success rates were 100% and 90.9%, respectively. All patients had a history of prior pancreatic endotherapy. The median (inter quartile range, [IQR]) stent indwell time was seven (6-10) months. The median visual analogue scale (VAS) pain score pre and post-FCSEMS was 8 (5-8) and 1 (0-2), respectively (p-value 0.003). Median (IQR) follow-up after stent removal was 48 (40-60) months. One patient (9%) developed de novo main pancreatic duct (MPD) stricture, which was asymptomatic. None of the patients had cholangitis, pancreatitis, perforation, proximal migration or stent fracture. The FCSEMS treatment appears to be safe, feasible and possibly an effective option for patients who have not responded to endoscopic plastic stenting.

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

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. 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. 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). Sarcopenia was identified as an independent risk factor for RBO in patients with pancreatic cancer with FCSEMS during NAT.

Fully covered self-expandable metallic stents versus plastic stents for preoperative biliary drainage in patients with pancreatic head cancer and the risk factors for post-endoscopic retrograde cholangiopancreatography pancreatitis.

Optimal stents for preoperative biliary drainage (PBD) for patients with possible resectable pancreatic cancer remain controversial, and risk factors for post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP), followed by PBD, are unknown. In this study, the efficacy and safety of fully covered self-expandable metallic stents (FCSEMSs) and plastic stents (PSs) were compared, and the risk factors for PEP, followed by PBD, were investigated for patients with pancreatic cancer. Consecutive patients with pancreatic cancer who underwent PBD between April 2005 and March 2022 were included. We retrospectively evaluated recurrent biliary obstruction, adverse events (AEs), and postoperative complications for FCSEMS and PS groups and investigated the risk factors for PEP. A total of 105 patients were included. There were 20 patients in the FCSEMS group and 85 patients in the PS group. For the FCSEMS group, the rate of recurrent biliary obstruction (0% vs. 25%, p = 0.03) was significantly lower. There was no difference in AE between the two groups. No significant differences were observed in the overall postoperative complications, but the volume of intraoperative bleeding was larger for the PS group than it was for the FCSEMS group (p < 0.001). From multivariate analysis, being female and lack of main pancreatic duct dilation were independent risk factors for pancreatitis (odds ratio, 5.68; p = 0.028; odds ratio, 4.91; p = 0.048). FCSEMSs are thought to be preferable to PSs for PBD due to their longer time to recurrent biliary obstruction. Being female and the lack of main pancreatic duct dilation were risk factors for PEP.

Efficacy of Fully Covered Self-Expandable Metal Stents for Distal Biliary Obstruction Caused by Pancreatic Ductal Adenocarcinoma: Primary Metal Stent vs. Metal Stent following Plastic Stent.

Fully covered self-expandable metallic stents (FCSEMSs) are inserted in patients with unresectable pancreatic ductal adenocarcinoma (PDAC) to resolve malignant distal bile duct obstructions. Some patients receive FCSEMSs during primary endoscopic retrograde cholangiopancreatography (ERCP), and others receive FCSEMSs during a later session, after the placement of a plastic stent. We aimed to evaluate the efficacy of FCSEMSs for primary use or following plastic stent placement. A total of 159 patients with pancreatic adenocarcinoma (m:f, 102:57) who had achieved clinical success underwent ERCP with the placement of FCSEMSs for palliation of obstructive jaundice. One-hundred and three patients had received FCSEMSs in a first ERCP, and 56 had received FCSEMSs after prior plastic stenting. Twenty-two patients in the primary metal stent group and 18 in the prior plastic stent group had recurrent biliary obstruction (RBO). The RBO rates and self-expandable metal stent patency duration did not differ between the two groups. An FCSEMS longer than 6 cm was identified as a risk factor for RBO in patients with PDAC. Thus, choosing an appropriate FCSEMS length is an important factor in preventing FCSEMS dysfunction in patients with PDAC with malignant distal bile-duct obstruction.

Endoscopic Ultrasound-Guided Gastrojejunostomy for Malignant Afferent Loop Syndrome Using a Fully Covered Metal Stent: A Multicenter Experience.

Endoscopic-ultrasound-guided gastrojejunostomy (EUS-GJ) can be a new alternative for patients with malignant afferent loop syndrome (MALS). However, a fully covered self-expandable metal stent (FCSEMS) has not been well investigated in this setting. This is a multicenter retrospective cohort study. Consecutive patients that underwent EUS-GJ using a FCSEMS for MALS between April 2017 and November 2022 were enrolled. Primary outcomes were technical and clinical success rates. Secondary outcomes were adverse events, recurrent symptoms, and overall survival. Twelve patients (median age: 67.5 years (interquartile range: 58-74.8); 50% male) were included. The most common primary disease and type of previous surgery were pancreatic cancer (67%) and pancreatoduodenectomy (75%), respectively. Technical success and clinical success were achieved in all patients. Procedure-related adverse events occurred in one patient (8%) with mild peritonitis. During a median follow-up of 96.5 days, one patient (8%) had recurrent symptoms due to the EUS-GJ stent dysfunction; including biliary events unrelated to the EUS-GJ stent, five patients (42%) had recurrent events. The median overall survival was 137 days. Nine patients (75%) died due to disease progression. EUS-GJ with a FCSEMS seems safe and effective for MALS with high technical and clinical success rates and an acceptable recurrence rate.

Uncovered versus fully covered self-expandable metal stents for the management of distal malignant biliary obstruction

Self-expandable metal stents (SEMSs) are widely used for palliation of distal malignant biliary obstruction (dMBO). However, previous studies comparing the outcomes between uncovered SEMSs (UCSEMSs) and fully covered SEMSs (FCSEMSs) report conflicting results. This large cohort study aimed to compare the clinical outcomes between UCSEMSs and FCSEMSs for dMBO. A retrospective cohort study was performed in patients with dMBO who underwent either UCSEMS or FCSEMS placement between May 2017 and May 2021. Primary outcomes were rates of clinical success, adverse events (AEs), and unplanned endoscopic reintervention. Secondary outcomes were types of AEs, intervention-free stent patency, and management and outcomes of stent occlusion. The cohort included 454 patients (364 in the UCSEMS group and 90 in the FCSEMS group). Median follow-up duration was 9.6 months and was similar between the 2 groups. Use of UCSEMSs and FCSEMSs had comparable clinical success (P= .250). However, use of UCSEMSs had significantly higher rates of AEs (33.5% vs 21.1%; P= .023) and unplanned endoscopic reintervention (27.0% vs 11.1%; P= .002). UCSEMSs had a higher rate of stent occlusion (26.9% vs 8.9%; P< .001) and shorter median time to stent occlusion (4.4 months vs 10.7 months; P= .002). Stent reintervention-free survival was higher in the FCSEMS group. FCSEMSs had a significantly higher rate of stent migration (7.8% vs 1.1%; P< .001), but patients in the FCSEMS group had similar rates of cholecystitis (.3% vs 1.1%; P= .872) and post-ERCP pancreatitis (6.3% vs 6.6%; P= .90). When UCSEMSs did occlude, placement of a coaxial plastic stent had a higher rate of stent reocclusion compared with coaxial SEMS placement (46.7% vs 19.7%; P= .007). FCSEMSs should be considered for the palliation of dMBO because of lower rates of AEs, longer patency rates, and lower rates of unplanned endoscopic intervention.

Management of biliary complications in liver transplant recipients using a fully covered self-expandable metal stent with antimigration features.

Following liver transplant (LT) with duct-to-duct anastomosis, biliary strictures and leaks are typically managed with endoscopic retrograde cholangiopancreatography (ERCP) and stenting. While multiple side-by-side plastic stents are typically used for management of anastomotic strictures, fully covered self-expandable metal stents (FCSEMS) can be used to decrease the number of ERCPs with longer periods of stent patency. The risk of migration can limit their use. FCSEMS with antimigration fins to manage benign biliary complications following LT may provide stricture resolution with limited adverse events (AEs). Single center retrospective study of LT patients who required FCSEMS from 1/2014 to 4/2022. Primary outcomes included stricture resolution and recurrence. Secondary outcomes were stent migration, occlusion, removability, and number of ERCPs. Forty-three patients (mean age 55.5 years) with anastomotic strictures (N.=37), bile leaks (N.=4) or both (N.=2) were included. The median time from LT to FCSEMS placement was 125 days. Within one year of LT, 31 patients required intervention; early intervention at less than 30 and 90 days was needed in 7 and 19 patients, respectively. The median length of follow up was 816.5 days. Stricture resolution was seen in 35 patients (81%) after a median stent dwell time of 130.5 days; recurrence occurred in 8 patients. There were three instances of partial stent migration that did not require reintervention or interfere with removability. The mean number of ERCPs required was 2.5. The use of a FCSEMS with antimigration features yields effective stricture resolution with longer stent dwell times and fewer ERCPs.