Search Results (14)

Background/Objectives: Endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) using a fully covered self-expandable metal stent (FCSEMS) is an alternative to endoscopic retrograde cholangiopancreatography for biliary drainage; however, FCSEMSs may cause intrahepatic bile duct (IHD) obstruction and cholangitis. In this study, we developed an FCSEMS with multiple self-made side holes at its tip and evaluated its safety and efficacy. Methods: This retrospective study included 100 patients who underwent EUS-HGS with FCSEMS placement between April 2022 and October 2023. Fifty patients received a conventional FCSEMS, and 50 received an FCSEMS with multiple self-made side holes. Technical and clinical success, residual contrast in the IHD, recurrent biliary obstruction (RBO), and adverse events (AEs) were then evaluated. The clinical success rates were 98% and 90% for the side hole and conventional FCEMS groups, respectively. The amount of residual contrast in the IHD was lower in the side hole group (0% vs. 12%, p = 0.027). RBO incidence was significantly lower in the side hole group (8% vs. 30%, p < 0.001), with migration as the primary cause in the conventional group. Early AEs, including segmental cholangitis, occurred only in the conventional group. During reintervention, all stents were safely removed. Conclusions: The FCSEMSs with multiple side holes reduced IHD occlusion and cholangitis, improving biliary drainage and safety. Further studies are needed to confirm these findings. Full article

Background: Over the last two decades, therapy for benign esophageal strictures has shifted from empirical dilatations and surgery to evidence-based and complex endoscopic and surgical procedures, aiming to achieve long-term esophageal patency. Aim: The purpose of our study is to provide descriptive evidence regarding the appropriate tailored medical, endoscopic, and surgical management of benign esophageal strictures. Methods: This retrospective study includes patients with benign esophageal strictures; the data collected encompass the complete patient profiles, detailed etiologic and anatomic workups of the strictures, comprehensive imaging, as well as management and follow-up details. Technical and clinical success rates, adverse events, stricture patency, and the need for additional therapy have been evaluated. Results: Most of the strictures (80.2%) were complex, requiring advanced techniques for management. The primary treatment involved endoscopic dilation, performed with Savary-Gillard bougie dilators in 76.7% of cases and pneumatic balloon dilators in 23.3% of cases. Clinical success was achieved in 95.3% of patients, with a significant improvement in the Ogilvie dysphagia score. Patients with caustic strictures required repeated dilations over the years, compared to shorter intervals for peptic strictures. Adverse events were minimal (e.g., perforation 2.3% and bleeding 4.7%) and managed predominantly endoscopically. Refractory strictures (16.3%) required advanced interventions, including fully covered self-expandable metallic stents (fc-SEMS) and corticosteroid injections. Conclusions: Both our data and the current literature support the use of tailored endoscopic strategies as the first-choice options for managing benign esophageal strictures. Our results strongly suggest against one-size-fits-all therapeutic alternatives. Full article

Esophagectomy, while a pivotal treatment for esophageal cancer, is not without adverse events. Among these, anastomotic leak (AL) is the most feared complication, threatening patient lives and incurring significant healthcare costs. The management of AL is complex and lacks standardization. Given the high morbidity and mortality rates associated with redo-surgery, which poses risks for already fragile patients, various endoscopic treatments have been developed over time. Self-expandable metallic stents (SEMSs) were the most widely used treatment until the early 2000s. The mechanism of action of SEMSs includes covering the wall defect, protecting it from secretions, and promoting healing. In 2010, endoscopic vacuum therapy (EVT) emerged as a viable alternative for treating ALs, quickly gaining acceptance in clinical practice. EVT involves placing a dedicated sponge under negative pressure inside or adjacent to the wall defect, aiming to clear the leak and promote granulation tissue formation. More recently, the VAC-Stent entered the scenario of endoscopic treatment of post-esophagectomy ALs. This device combines a fully covered SEMS with an integrated EVT sponge, blending the ability of SEMSs to exclude defects and maintain the patency of the esophageal lumen with the capacity of EVT to aspirate secretions and promote the formation of granulation tissue. Although the literature on this new device is not extensive, early results from the application of VAC-Stent have shown promising outcomes. This review aims to synthesize the preliminary efficacy and safety data on the device, thoroughly analyze its advantages over traditional techniques and disadvantages, explore areas for improvement, and propose future directions. Full article

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. Full article

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. Full article

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. Full article

Background: 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. Methods: 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. Results: 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. Conclusions: EUS-GJ with a FCSEMS seems safe and effective for MALS with high technical and clinical success rates and an acceptable recurrence rate. Full article

Introduction. Pancreatic ductal adenocarcinoma (PDA) is associated with poor prognosis and 98% loss-of-life expectancy. 80% of patients with PDA are unfit for radical surgery. In those cases, emphasis is set on management of cancer-related symptoms, among which obstructive jaundice is most common. Endoscopic ultrasound-guided biliary drainage (EUS-BD) emerges as a valid alternative to the well-accepted methods for treatment of biliary obstruction. Patient Selection. Five consecutive patients with unresectable pancreatic malignancy, were subjected to EUS-BD, particularly EUS-guided choledochoduodenostomy (EUS-CDS). Ethics. Oral and written informed consent was obtained in all cases prior procedure. Technique. EUS-guided puncture of the common bile duct was performed, followed by advancement of a guidewire to the intrahepatic bile ducts. After dilation of the fistulous tract with a cystotome, a fully covered self-expandable metal stent was inserted below the hepatic confluence and extending at least 3 cm in the duodenum. Technical and clinical success was achieved in four patients without adverse events. In one patient procedure failed due to dislocation of the guidewire, with consequent biliary leakage requiring urgent surgery. Recovery was uneventful with no further clinical sequelae and there was no mortality associated with procedure. Discussion. Introduced in 2001, EUS-guided biliary drainage has become an accepted option for treatment of obstructive jaundice. According to recent guidelines published by European Society of Gastrointestinal Endoscopy (ESGE) in 2022, EUS-CDS is a preferred modality to percutaneous transhepatic biliary drainage (PTBD) and surgery in patients with failed ERCP, with comparable efficiency and better safety profile, which is supported by our experience with the procedure. Conclusions. Our case series suggests that EUS-CDS is an excellent option for palliative management of malignant distal biliary obstruction, emphasizes on the importance of adequate technique and experience for the technical success, and urges the need for future research on establishing the best choice for guidewire and dilation device. Full article

Background: In the case of an unresectable malignant hilar biliary obstruction (MHBO), the optimal drainage method has not yet been established. Recently, an 8 mm, fully covered, self-expandable metal stent (FCSEMS) with an ultra-slim introducer has become available. In this article, the results of whole-liver drainage tests using this novel FCSEMS for MHBO are reported. Methods: Unresectable MHBOs up to Bismuth IIIa with strictures limited to the secondary branches were eligible. The proximal end of the stent was placed in such a way as to avoid blocking the side branches, and the distal end was placed above the papilla when possible. Consecutive patients treated between April 2017 and January 2021 were retrospectively analyzed. The technical and functional success rates, rates and causes of recurrent biliary obstruction (RBO), time to RBO (TRBO), revision for RBO, and adverse events (AEs) were evaluated. Results: Eleven patients (Bismuth I/II/IIIa: 1/7/3) were enrolled. Two stents were placed in nine patients and three were placed in two patients. Both the technical and functional success rates were 100%. RBO occurred in four (36%) patients due to sludge formation. Revision was performed for three patients, with the successful removal of all stents. The median TRBO was 187 days, and no late AEs other than the RBO occurred. Regarding the distal position of the stent, the RBO rate was significantly lower (14.3% vs. 75%, p = 0.041) and the cumulative TRBO was significantly longer (median TRBO: not reached vs. 80 days, p = 0.031) in the case of the placement above the papilla than the placement across the papilla. Conclusion: For unresectable MHBOs of Bismuth I, II, and IIIa, whole-liver drainage with a novel 8 mm FCSEMS possessing an ultra-slim introducer was feasible and potentially safe, with favorable stent patency. Placement above the papilla might be preferrable to placement across the papilla. Full article

Background/Aims: Endoscopic management by endoscopic sphincterotomy with or without plastic stents or fully covered self-expandable metallic stents (FCSEMSs) is widely accepted as the current standard of care for postoperative bile leaks. Biliary stents are placed across the papilla, not above the papilla. We investigated the safety and effectiveness of the bridge-and-seal technique for bile leaks by the placement of FCSEMS above the papilla. Methods: This was a retrospective study of FCSEMS placement above the papilla for bile leaks between October 2016 and July 2021. FCSEMS was placed above the papilla to bridge and seal the leak. The main outcome measures were the resolution of bile leaks and adverse events. Results: Seven patients with postoperative bile leaks underwent FCSEMS above the papilla. The locations of bile leaks were 1 cystic duct remnant; 2 intrahepatic bile duct; 1 hepatic duct; 2 common bile duct and 1 anastomosis. The technical success rate of FCSEMS placement was 100%, and resolution of bile leaks was achieved in five patients (71.4%). All the adverse events were observed after FCSEMS removal; as follows: 1 moderate cholangitis; 2 mild post-ERCP pancreatitis; and 1 mild remnant cholecystitis. Conclusions: FCSEMS placement above the papilla can be a treatment option for postoperative bile leaks. Full article

Self-expandable metallic stents (SEMSs) are typically inserted in patients with unresectable malignant biliary obstruction. However, SEMSs are susceptible to occlusion. To overcome this issue, we developed a large-bore, dumbbell-shaped, fully covered SEMS (FCSEMS-L) and compared its efficacy and safety with those of a conventional FCSEMS (FCSEMS-C) in patients with malignant biliary obstruction. Methods: Patients with unresectable distal malignant biliary obstruction were retrospectively enrolled between January 2011 and February 2021. All patients underwent endoscopic insertion of FCSEMSs. Recurrent biliary obstruction (RBO), patient survival time, complications, and prognosis were analyzed. Results: RBO occurred in 31 patients (35.6%) who received an FCSEMS-L, and in 34 (45.9%) who received an FCSEMS-C. Stent occlusion occurred in 19 patients (21.8%) who received an FCSEMS-L, and in 22 (29.7%) who received an FCSEMS-C. Stent migration occurred in 12 patients (13.8%) with an FCSEMS-L and 12 (16.2%) with an FCSEMS-C. The median time to RBO (TRBO) was 301 days with an FCSEMS-L and 203 days with an FCSEMS-C. The median survival time was 479 days with an FCSEMS-L and 523 days with an FCSEMS-C. The TRBO and patient survival time did not significantly differ between the two groups. Conclusions: There were no significant differences in efficacy and complication rates between the fully covered large bore SEMSs and conventional fully covered SEMSs. Full article

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. Full article

Background and aims: The goals of the management of benign biliary stricture (BBS) are to relieve symptoms and resolve short-/long-term stricture. We performed fully covered self-expandable metallic stent (hereafter, FCSEMS) placement for BBS using various methods and investigated the treatment outcomes and adverse events (AEs). Methods: We retrospectively studied patients who underwent FCSEMS placement for refractory BBS through various approaches between January 2017 and February 2020. FCSEMS were placed for 6 months, and an additional FCSEMS was placed if the stricture had not improved. Technical success rate, stricture resolution rate, and AE were measured. Results: A total of 26 patients with BBSs that were difficult to manage with plastic stents were included. The mean overall follow-up period was 43.3 ± 30.7 months. The cause of stricture was postoperative (46%), inflammatory (31%), and chronic pancreatitis (23%). There were four insertion methods: endoscopic with duodenoscopy, with enteroscopy, EUS-guided transmural, and percutaneous transhepatic. The technical success rate was 100%, without any AE. Stricture resolution was obtained in 19 (83%) of 23 cases, except for three cases of death due to other causes. Stent migration and cholangitis occurred in 23% and 6.3%, respectively. Stent fracture occurred in two cases in which FCSEMSs were placed for more than 6 months (7.2 and 10.3 months). Conclusion: FCSEMS placement for refractory BBS via various insertion routes was feasible and effective. FCSEMSs should be exchanged every 6 months until stricture resolution because of stent durability. Further prospective study for confirmation is required, particularly regarding EUS-guided FCSEMS placement. Full article

Esophageal stent insertion has been used as a well-accepted and effective alternative to manage and improve the quality of life for patients diagnosed with esophageal diseases and disorders. Current stents are either permanent or temporary and are fabricated from either metal or plastic. The partially covered self-expanding metal stent (SEMS) has a firm anchoring effect and prevent stent migration, however, the hyperplastic tissue reaction cause stent restenosis and make it difficult to remove. A fully covered SEMS and self-expanding plastic stent (SEPS) reduced reactive hyperplasia but has a high migration rate. The main advantage that polymeric biodegradable stents (BDSs) have over metal or plastic stents is that removal is not require and reduce the need for repeated stent insertion. But the slightly lower radial force of BDS may be its main shortcoming and a post-implant problem. Thus, strengthening support of BDS is a content of the research in the future. BDSs are often temporarily effective in esophageal stricture to relieve dysphagia. In the future, it can be expect that biodegradable drug-eluting stents (DES) will be available to treat benign esophageal stricture, perforations or leaks with additional use as palliative modalities for treating malignant esophageal stricture, as the bridge to surgery or to maintain luminal patency during neoadjuvant chemoradiation. Full article