Fully Covered Self-expandable Metal Stents Research Articles

OGC SO40 - Oesophageal Stents with fixation device for anastomotic leaks after oesophagectomy: Our initial experience

Abstract Background Anastomotic leaks following oesophagectomy are associated with significant morbidity and mortality. The management of these leaks also presents significant clinical and nutritional challenges. The role of endoscopic interventions such as endoluminal vacuum therapy and endoscopic stents in management of these leaks has increased over the past decade. We present our experience in the use of endoscopic stents with a stent fixation device over the last 4 years. Method Detailed patient records were retrospectively reviewed to assess the indications, procedural success, complications and overall clinical outcomes for patients with anastomotic leaks following Ivor-Lewis oesophago-gastrectomy (ILO) at our institution from January 2021 to June 2024 treated endoscopically with fully-covered self-expanding metal stents using stent fixation devices. Results 5 patients had post-ILO anastomotic leaks treated with endoscopic stents. The stents were fixed to the proximal oesophagus using a stent fixation device (Stentfix clip). 1of the 5 patients continued to leak despite the stent, leading to prolonged recovery. The remaining 4 achieved leak resolution after stent insertion without needing further intervention. No stent-related procedural complications were noted. The patients progressed on to oral diet/nasogastric feeding within a median of 8 days (Range: 1-18). The median hospital stay following stenting was 29 days (range 7-39). The stents remained in situ for 3 months and were succcesfully removed endoscopically thereafter. Conclusion Endoscopic stenting with a fully covered stent and a stent fixation device (alongside pleural drainage) is a highly effective and safe intervention for managing anastomotic leaks after ILO. It does not entail multiple procedure and oral feeding can be commenced relative quickly. It potentially minimizing the need for more complex procedures and reduces overall hospital stay and costs in the management of anaestomotic leaks.

Endoscopic removal of a deteriorated fully-covered self-expandable metal stent using an endoscopic retrograde cholangiopancreatography guide sheath

Endoscopic removal of a deteriorated fully-covered self-expandable metal stent using an endoscopic retrograde cholangiopancreatography guide sheath

Endoscopic sphincterotomy to prevent post-ERCP pancreatitis after self-expandable metal stent placement for distal malignant biliary obstruction (SPHINX): a multicentre, randomised controlled trial

BackgroundEndoscopic retrograde cholangiopancreatography (ERCP) with fully covered self-expandable metal stent (FCSEMS) placement is the preferred approach for biliary drainage in patients with suspected distal malignant biliary obstruction (MBO). However, FCSEMS...

Optimizing EUS-guided choledochoduodenostomy with lumen-apposing metal stents for primary drainage of malignant distal biliary obstruction (SCORPION-IIp): a prospective pilot study

Background and AimsBiliary drainage by endoscopic retrograde cholangiography (ERCP) in patients with malignant distal bile duct obstruction (MBO) is frequently associated with complications, such as pancreatitis, hampering patient outcome. EUS-guided choledochoduodenostomy (EUS-CDS) with a lumen-apposing metal stent (LAMS) is a promising alternative in patients with MBO but is associated with a worrisome risk of stent dysfunction. Placement of a fully covered self-expandable metal stent (FCSEMS) through the LAMS, thereby changing the axis of biliary drainage towards the descending duodenum, may decrease the risk of stent dysfunction while maintaining high technical success and low adverse event rates. MethodsProspective single center pilot study in patients with a pathology confirmed MBO without gastric-outlet obstruction. Primary outcome was stent dysfunction, defined as recurrent jaundice after initial clinical success, ongoing jaundice in combination with persistent bile duct dilatation, or cholangitis. The study was registered in clinicaltrials.gov (registry number NCT05595122). ResultsOverall, 27 consecutive patients eligible for EUS-CDS were enrolled. The placement of a LAMS was successful in 24/27 patients (89%), and placement of FCSEMS through the LAMS was successful in 20/24 (83%), in the remaining 4 patients a coaxial double-pigtail plastic stent was placed. In 2 of these 20 patients there was persistent jaundice requiring stent revision (10%), leading to a clinical success rate of 90%. No patients developed stent dysfunction after initial clinical success. ConclusionsThis study showed a stent dysfunction rate of 10% following technically successful EUS-CDS with placement of a FCSEMS through the LAMS. Improving the design of LAMS may further reduce the rate of stent dysfunction.

EP542 - ERCP removal of self-expanding metal stent (SEMS) after 25 months

Abstract This abstract highlights a less-explored complication associated with Endoscopic Retrograde Cholangiopancreatography (ERCP) – the delayed removal of pancreatic or biliary stents. The case study involves a 45-year-old woman with a Self-Expandable Metal Stent (SEMS) in place for an extended period of 2 years. Initially, the patient sought medical attention due to episodic epigastric pain, revealing gallstones partially obstructing the common bile duct. An initial ERCP aimed to extract the stones, but a large stone proved challenging to remove. Subsequently, a temporary Fully Covered Self-Expandable Metal Stent (FC-SEMS) was inserted. A follow-up ERCP was planned to remove both the stone and the stent. However, the patient experienced intolerability during the procedure and developed post-ERCP pancreatitis, leading her to decline the second ERCP. In the following year, the patient faced transient common bile duct (CBD) blockage and ascending cholangitis episodes. After thorough discussion with the medical team, she consented to a second ERCP. During this procedure, it was discovered that the SEMS had ingrowth of duodenal mucosa at the proximal end. Successfully removing the SEMS and stone required using a needle knife to dissect the duodenal mucosa of the stent and flipping the stent inside out, as the tissue around the stent was challenging to access. This case underscores the challenges and risks associated with prolonged stent retention. The abstract strongly recommends against leaving the stent in place for an extended duration and advocates for attempting stent removal through ERCP before considering a surgical approach.

Comparative Efficacy and Safety of Different Stent Types for Pancreatic Fluid Collections: A Systematic Review and Network Meta-Analysis.

Drainage of pancreatic fluid collections (PFCs) is required in select cases including infected or symptomatic collections. In this network meta-analysis, we have compared lumen-apposing metal stents (LAMS), fully covered self-expandable metal stents (FCSEMS), and double-pigtail stents (DPS) to identify the most useful stent type in the management of PFCs. We reviewed several databases to identify studies that compared DPS or FCSEMS with LAMS and the ones which compared DPS with FCSEMS for the treatment of PFCs. Our outcomes of interest were clinical success, adverse events, technical success, recurrence of PFCs, and procedure duration. Random effects model and frequentist approach were used for statistical analysis. We included 28 studies with 2974 patients. Rate of clinical success was significantly lower with DPS compared to LAMS, OR (95% CI): 0.43 (0.32, 0.59). Rate of recurrence was higher with DPS compared to LAMS, OR (95% CI): 2.06 (1.19, 3.57). We found no significant difference in rate of adverse events between groups. Rate of technical success was higher for FCSEMS compared to LAMS. Procedure duration was significantly shorter for LAMS compared to DPS and FCSEMS. Based on frequentist approach, LAMS was found to be superior to DPS and FCSEMS in achieving higher clinical success, lower rate of adverse events and recurrence, and shorter procedure time. This network meta-analysis demonstrates the superiority of LAMS over DPS and FCSEMS in the management of PFCs in achieving a higher clinical success, shorter procedure time, and lower rate of recurrence. Some of the analyses are not adequately powered to make firm conclusions, and future large multicenter RCTs are required to further evaluate this issue.

Fully-Covered Self-Expandable Metal Stent for Hepaticojejunostomy Anastomotic Stricture After Living Donor Liver Transplantation: A Case Series

We prospectively evaluated 3 cases regarding the usefulness of fully-covered self-expandable metal stents (FCSEMSs) for hepaticojejunostomy anastomotic stricture (HAS) after living donor liver transplantation (LDLT), which could not be resolved with conventional treatment using a plastic stent. All patients underwent LDLT with Roux-en-Y reconstruction; therefore, a short-type double-balloon enteroscope was used for the endoscopic procedures. HAS was observed on enteroscopic view of endoscopy in patients 1 and 2, and cholangiography revealed dilatation of the intrahepatic bile duct. The FCSEMS was successfully placed without the report of adverse events. The FCSEMS was removed after 16 weeks, and the HAS improved in both patients. In addition, stone clearance was also achieved in patient 2. On the other hand, FCSEMS was not placed in patient 3 because there was no indication of FCSEMS placement due to the multiple segmental biliary strictures (pruned-tree appearance on cholangiography). Subsequent deceased-donor liver transplantation confirmed recurrent primary sclerosing cholangitis. In this case, magnetic resonance cholangiopancreatography (MRCP) was not performed prior to cholangiography to rule out PSC recurrence. FCSEMS placement may be effective and safe for HAS after LDLT, which is not resolved with conventional treatment using a plastic stent. MRCP should be used to identify HAS prior to invasive cholangiography.

Evaluating no fixation, endoscopic suture fixation, and an over-the-scope clip for anchoring fully covered self-expanding metal stents in benign upper gastrointestinal conditions: a comparative multicenter international study (With Video)

Fully covered self-expandable metal stents (FCSEMSs) are widely used in benign upper gastrointestinal (GI) conditions, but stent migration remains a limitation. An over-the-scope clip (OTSC) device (Stentfix {SF], Ovesco Endoscopy) for stent anchoring has recently been developed. The aim of this study was to evaluate the effect of OTSC fixation on FCSEMS migration rate. In this retrospective review of consecutive patients who underwent FCSEMS placement for benign upper GI conditions from January 2011 to October 2022 at 16 centers, the primary outcome was rate of stent migration. The secondary outcomes were clinical success and adverse events. A total of 311 (no fixation [NF] 122, SF 94, endoscopic suturing [ES] 95) patients underwent 316 stenting procedures. Compared with the NF group (n= 49, 39%), the rates of stent migration were significantly lower in the SF (n= 16, 17%, P= .001) and ES (n= 23, 24%, P= .01) groups. The rates of stent migration were not different between the SF and ES groups (P= .2). On multivariate analysis, SF (odds ratio [OR], 0.34, 95% CI, 0.17-0.70, P< .01) and ES (OR, 0.46, 95% CI, 0.23-0.91; P= .02) were independently associated with decreased risk of stent migration. Compared with the NF group (n= 64; 52%), there were higher rates of clinical success in the SF (n= 64; 68%; P= .03) and ES (n= 66; 69%; P= .02) groups. There was no significant difference in the rates of adverse events among the 3 groups. Stent fixation using OTSCs is safe and effective at preventing stent migration and may also result in improved clinical response.

A Comprehensive Analysis of Reported Adverse Events and Device Failures Associated with Esophageal Self-Expandable Metal Stents: An FDA MAUDE Database Study.

Esophageal Stents are used to maintain esophageal lumen patency in esophageal strictures caused by intrinsic and/or extrinsic malignancies and the occlusion of concomitant esophageal fistulas. While data on the efficacy and safety of esophageal stents exist, comprehensive evaluation of adverse events is limited. The aim of this study is to investigate the reported adverse events and device failures associated with esophageal self-expandable metal stents (SEMS) using the FDA's Manufacturer and User Facility Device Experience (MAUDE) database. Post-marketing surveillance data for the esophageal SEMSs were analyzed using the FDA's MAUDE database from January 2014 to December 10, 2023. The outcomes of interest were patient-related adverse events and device failures. Statistical analysis was performed using Microsoft Excel 2010 and SPSS. Pooled numbers and percentages were calculated for each adverse event. Continuous variables underwent analysis using a two-tailed student t test, and significance was set to p ≤ 0.05. During the study period, 548 MAUDE reports revealed 873 device failures and 186 patient-related adverse events. The most common device issues were stent activation, positioning, or separation problems (4 n = 403; 46.2%), followed by device detachment or migration (n = 109, 12.5%), and material problems (n = 93, 10.7%). Patient complications included dysphagia/odynophagia (10%), perforation, pain, and bleeding (each 7.6%). The most common device failures in over-the-wire (OTW) stents and through-the-scope (TTS) stents were activation, positioning, or separation problems (TTS: n = 183, 52.6% vs OTW: n = 220, 41.9%). Compared to OTW stents, TTS stents had higher migration and breakage (13.5% vs. 11.8%, p = 0.24), and (9.2% vs. 6.7%, p = 0.08) respectively, while OTW stents had more challenges with stent advancement or removal (5.1% vs. 0.3%, p < 0.001 and 4.6% vs 3.4%, p = 0.19, respectively) and material problems (14.7% vs. 4.6%, p < 0.001). Activation, positioning, and separation problems were the most frequent device failures in fully covered (FC) and partially covered (PC) stents (FC: n = 62, 32.8%, PC: n = 168, 43.5%). FC stents had higher migration rates (20.6% vs 9.8%, p < 0.001), while PC stents exhibited more material problems (17.4% vs. 5.8%, p < 0.001) and difficulties with advancing the stents (6.7% vs. 0%, p < 0.001). Our examination showed a prevalence of reported device complications associated with stent activation, positioning, and separation problems. Dysphagia or odynophagia emerged as the most frequently reported patient complication. Furthermore, our analysis, provides insights into TTS vs. OTW and FC vs. PC esophageal SEMSs, enabling endoscopists and manufacturers to better understand adverse events and potentially optimize device design for future iterations.

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

Endoscopic interventions for bile duct stones (BDSs) with benign choledochojejunal anastomotic stenosis (bCJS) are challenging. Therefore, we investigated endoscopic interventions for BDSs with bCJS. Seventeen patients with BDSs with bCJS were retrospectively analyzed. Patient characteristics, technical success, adverse events (AEs), and recurrence were evaluated. In 17 patients, the median diameters of the bile duct and BDSs were both 8mm. The median number of BDSs 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 10.5mm, and waist disappearance was achieved in 2. Six patients had fully covered self-expandable metal stents (FCSEMSs) with a diameter of 10mm placed at the CAS. BDSs were removed after balloon dilation or FCSEMS removal, and 6 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 of 16 patients (56%) had recurrence. The patients treated with a combination of PDCS at BDS removal (P= .022) and waist disappearance at the CAS by balloon dilation (P= .035) had significantly fewer recurrences. Endoscopic interventions for BDSs with bCJS are useful and relatively safe; however, long-term follow-up 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.

Risk factors of stent migration in esophageal cancer patients who underwent fully-covered self-expanding metal stents for malignant dysphagia or tracheoesophageal fistula

BackgroundMore than 50% of esophageal cancer patients are diagnosed with advanced diseases and commonly experience dysphagia, some of whom even have tracheoesophageal fistula. Self-expandable metal stent (SEMS) is one of the recommended palliative methods, although complications such as chest pain and stent migration are not uncommon. The goal of this study was to examine the predictors of stent migration. MethodsWe conducted a retrospective cohort study to include patients with esophageal cancer and dysphagia/tracheoesophageal fistula. Clinicopathological information, stent characteristics and patient outcomes were collected for analysis, while side-effects of SEMS were recorded, potential predictors were examined, and patients’ nutritional outcomes were compared in the migration and non-migration groups. ResultsA total of 54 patients with esophageal cancer who received fully covered SEMS between 2013 and 2022 were included. We found tumor across the esophagogastric junction (adjusted odds ratio (OR) = 32.64, P = 0.01) and the female sex (adjusted OR = 12.5, P = 0.02) were significant predictors for stent migration. There was a decreasing tendency in body mass index/body weight in migration and non-migration groups, but the former had a steeper downslope. ConclusionFully covered SEMS is a safe and effective strategy to palliate dysphagia or fistula. Tumor across esophagogastric junction and the female sex were higher risk predictors of stent migration. A careful patient selection would optimize the effects of SEMS placement, especially in those with short-expected lifespan.

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.

Endoscopic multiple plastic stents are an established first-line treatment for anastomotic biliary stricture (ABS) management after liver transplantation (LT). Fully covered self-expandable metallic stents (FCSEMSs) have recently been used with favorable outcomes, but long-term treatment outcomes remain an issue for ABS. We evaluated the long-term outcomes of FCSEMS for the management of refractory ABS after LT. We reviewed the prospectively collected and maintained endoscopic retrograde cholangiography database at Asan Medical Center to retrieve consecutive post-LT ABS cases that underwent an endoscopic FCSEMS placement between August 2009 and August 2019 after MPS placement failure. A total of 34 patients were enrolled in this study. Technical success had been achieved in all subjects (100%). The median stent placement duration was 3.1months (IQR 2.7-6.1). Stricture resolution was achieved in 26 patients (clinical success 76.5%, 95% confidence interval 62-91). Early adverse events developed in 3 patients (8.8%), including distal stent migration. Late adverse events occurred in 9 patients (26.5%), including cholangitis (n = 7, 20.6%) and asymptomatic distal stent migration (n = 2, 5.9%). The median follow-up period was 57.9months (IQR 51.9-64.3). Stricture recurrence occurred in 3 of 26 patients who achieved clinical success (11.5%). FCSEMS placement appears to be an effective and advisable intervention for refractory ABS as it can provide persistent stricture improvement over the long-term.

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.

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.).

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.