Self-expanding Metal Stents Research Articles

HPB SO03 - Preoperative biliary drainage prior to pancreaticoduodenectomy for pancreatic head malignancy: Guidelines versus the reality

Abstract Background British guidelines currently advise against routine preoperative biliary stenting (PBS) unless patients have cholangitis or organ failure secondary to biliary obstruction. If stenting is required, self-expanding metal stents are advocated. Using a large multicentre cohort, this study aimed to investigate the proportion of patients who underwent PBS prior to pancreatoduodenectomy (PD) and describe the approach used. Method Data were extracted from the Recurrence After Whipple’s (RAW) study, a multicentre retrospective cohort study of outcomes of PD performed for histologically confirmed pancreatic head malignancy (29 centres from 8 countries, n=1484). Patients who underwent PBS were identified and the details surrounding this were obtained. Results 1482 patients had data on use of PBS. 427 didn't undergo PBS, 1055 underwent attempted PBS. Of the latter, 989 had a stent placed successfully, 38 had PBS failed , and 28 had an external biliary drain . when PBS performed, Among 857 were primary endoscopically placed , 75 had percutaneously placed PBS having failed endoscopy , and 50 had a primary percutaneously placed PBS . 755 patients known stent material ( 66% were plastic, 34% metal). In 671 who had data regarding cytology from PBS known, 48% had cytology suggestive/diagnostic of malignancy, 25% had inadequate histology, and 28% did not send a cytology sample. Conclusion Despite guidelines advising against routine PBS, over two thirds of PD patients in our study underwent stenting. Despite guidelines advocating metal stents when PBS is necessary, two thirds of the stents deployed were plastic. Stent cytology has a low sensitivity for pancreatic head malignancy.

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.

Self-Expanding Metal Stents in the Acute Management of Oesophageal Variceal Bleeding: A Systematic Review.

Acute variceal bleeding (AVB) continues to challenge physicians and healthcare systems. Despite significant advances in our multimodal approach to managing this problem, namely medical, endoscopic, and radiological techniques, the mortality rates for this patient cohort remain as high as 20% on the index admission. This mortality rate has remained unchanged over the past 25 years. A crucial tool in the management of AVB is the balloon tamponade technique. However, this is associated with numerous severe and potentially life-threatening adverse events. Due to the limitations of oesophageal balloon tamponade devices, there has been an increased interest in using self-expanding metal stents (SEMS) to manage refractory variceal bleeding. There is a base of experience in using SEMS derived from their use in managing malignant obstructions. This study aimed to synthesise all available evidence, for the first time, on using SEMS to manage refractory oesophageal AVB. This study was a systematic review of published papers, which is reported per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. We identified 16 suitable studies for review. These comprised one randomised controlled trial comparing SEMS to balloon tamponade, one prospective cohort study, nine retrospective cohort studies, four case reports, and one case series. In total, 246 patients were included. An average survival rate of 49% was seen among the 11 studies that reported a six-week survival rate; this included a cohort of 225 patients. The SEMS were left in situ for an average of 7.5 days, with a maximum average of 18 days in one study. The average rate for controlling the acute bleeding episode in patients receiving a SEMS was 96%. The re-bleeding rate on the removal of SEMS was 5%, far superior to the widely reported 50% re-bleeding rate for the balloon tamponade technique. The adverse event profile for the SEMS appears superior to the balloon tamponade technique overall. The rate of stent-related adverse events in patients receiving a SEMS was 25%. The most common adverse events were technical issues related to stent functioning, namely stent migration. The most severe stent-related adverse event was compression of the left main bronchus in two cases, which required the removal of the stent. Our study has several limitations, which we have alluded to throughout the paper. The studies on this issue are of poor quality, with only one randomised controlled trial performed. As a result, we must interpret the results of our research with caution. Our study supports the use of SEMS in managing AVB as a promising area of research. We have highlighted that further well-designed randomised controlled trials are needed to assess the efficacy of this technique, ideally compared directly to the balloon tamponade technique. However, based on this systematic review, the current body of evidence would suggest that the SEMS is superior to the balloon tamponade technique in terms of adverse event profile, re-bleeding rate, and length of time the device can safely be left in situ. Current evidence suggests that SEMS are as effective at controlling acute bleeding episodes as the balloon tamponade technique.

Endoscopic ultrasound-guided choledochoduodenostomy using an innovatively shaped self-expandable metal stent to prevent stent migration.

Endoscopic ultrasound-guided choledochoduodenostomy using an innovatively shaped self-expandable metal stent to prevent stent migration.

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

Thin Delivery Stents Can Obviate the Need for Additional Fistula Dilatation of Large Diameter in Endoscopic Ultrasound-Guided Hepaticogastrostomy.

Background/Objectives: Endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) often requires fistula dilation owing to the placement of a large diameter of the delivery stent. The recently developed delivery devices, which are as thin as 5.9/6.0 Fr, may save the need for fistula dilation. Therefore, we investigated whether large fistula dilation would be required or not in the case of this newly developed thin-diameter delivery stents. Methods: We conducted a retrospective study involving 33 patients implemented with a self-expandable metal stent (SEMS) during EUS-HGS. The patients were categorized based on the delivery device diameter into thin (n = 13; delivery device diameter: 5.9/6.0 Fr) and thick (n = 20; delivery device diameter: 8.5 Fr) groups. We compared the initial rate of success, technical success, and clinical success between the thin and thick groups. The initial rate of success was defined as successful stent placement without a balloon or large diameter mechanical dilation. Results: The rate of the initial stenting success was significantly higher in the thin group (100% [13/13]) compared with that in the thick group (65.0% [13/20]) (p = 0.027). In the thick group, seven cases with technical difficulty in terms of stent placement could be successfully completed with additional fistula dilation with a 9 Fr bougie dilator or 4 mm balloon dilator; this resulted in a technical success of 100% in both groups ultimately. The rate of clinical success was 100% and 95.0% in the thin and thick groups, respectively (p = 1.00). Conclusions: Thin delivery stents may facilitate stent placement without the need for a balloon fistula or large-diameter mechanical dilation.

Predictors of symptom recurrence and survival in patients with malignant gastric outlet obstruction treated with self-expanding metal stents.

Malignant gastric outlet obstruction (GOO) poses a substantial symptomatic burden. While various therapeutic options exist, self-expanding metal stents (SEMS) are a common palliative choice for patients who are ineligible for surgery. We studied SEMS outcomes to identify factors influencing stent dysfunction and patient survival. A multi-centre, retrospective review of 190 patients with GOO undergoing SEMS at three tertiary hospitals was performed over 2016-2022. Technical success, clinical success and adverse outcomes were recorded. Predictors of stent dysfunction and survival were evaluated using multivariate regression. Technical success was achieved in 186/190 (97.9%) and clinical success in 156/186 (83.9%), defined as post-procedural gastric outlet obstruction symptom score (GOOSS) ≥2. Eighty-two (44.1%) patients experienced an adverse event with stent occlusion the most common (23.1%). Approximately one-third (32.3%) underwent a repeat intervention. Mean stent patency time was 67 days (standard deviation=76), and median post-stent survival was 95 days (37-197). Covered and partially covered SEMS carried three times the risk of stent dysfunction compared to uncovered SEMS (odds ratio 3.06, p=0.008). Mortality predictors were Eastern Cooperative Oncology Group score ≥2 (p=0.03), extrinsic outlet obstruction (p=0.05) and presence of ascites (p=<0.001). SEMS demonstrated technical and clinical success but posed a high risk of recurrence, with stent patency time falling short of survival in our cohort. With an evolving landscape of therapeutics for GOO, appropriate patient selection is paramount. Individuals with reduced performance status, extrinsic obstruction and/or ascites may be better candidates for SEMS due to more limited life expectancy. In this setting, uncovered SEMS carry the lowest risk of reintervention.

Low-pressure self-expandable metal stent insertion for obstructive colon cancer using water and gel immersion.

Low-pressure self-expandable metal stent insertion for obstructive colon cancer using water and gel immersion.

Prognostic value of carcinoembryonic antigen (CEA) and CA 19-9 levels in patients with obstructive colorectal cancer treated with a self-expandable metallic stent and curative surgery.

The importance of tumor markers is well established; yet little is known about their prognostic value for patients with obstructive colorectal cancer (OCRC). We investigated the clinical significance of carcinoembryonic antigen (CEA) and CA 19-9 levels in patients with non-metastatic OCRC, who underwent insertion of a self-expandable metallic stent and curative surgery. Clinical data on 91 patients with OCRC were analyzed retrospectively to evaluate the associations of preoperative serum values of tumor makers with short- and long-term outcomes. The 91 patients comprised 53 men and 38 women, with a median age of 71years. Twelve patients had an elevated preoperative CA 19-9 level. Multivariate analyses revealed that an elevated CA 19-9 level was independently associated with poor disease-free survival (DFS) [hazard ratio (HR) = 4.57, 95% confidence interval (CI) 2.06-10.14, P < 0.001] and overall survival (HR = 4.06, 95% CI 1.46-11.24, P = 0.007). A CEA level > 5ng/ml had no prognostic value, whereas a CEA level > 10.8ng/ml was significantly associated with worse DFS (P = 0.032). Measuring the CA 19-9 level concomitantly with the CEA level for patients with advanced CRC, including OCRC, may provide a valuable means to improve prognostication.

Impact of a novel-covered colonic stent in obstructive colon cancer.

Although the short-term outcomes of bridge-to-surgery (BTS) procedures using self-expandable metal stents are favorable, concerns remain regarding worsened prognosis due to tissue injury in the tumor area. Herein, we describe a newly developed covered stent, the Kawasumi Jabara colonic stent™, designed to reduce tissue damage/injury associated with stent-related complications in BTS procedures. This study aimed to evaluate the efficacy and safety of the Kawasumi Jabara colonic stent as a BTS for obstructive colorectal cancer (OCC). This multicenter retrospective observational study included 44 OCC patients who underwent BTS with stents at four facilities between September 2020 and November 2022. The groups of patients receiving the Kawasumi Jabara and non-covered colonic stents were designated Groups C and NC, respectively. Treatment outcomes related to stent placement and surgery were compared using propensity score matching (PSM) analysis. Groups NC and C (n = 34 and 10, respectively) showed no significant differences in sex, age, tumor location, histological type, Colorectal Obstruction Scoring System (CROSS) score, or cStage; however, the stent placement duration was shorter in Group C. No significant differences were found in terms of the technical and clinical success rates for stent placement. Stent dislocation was observed in 0 and 2 cases in Groups C and NC, respectively. PSM analysis between eight cases, each from Groups C and NC, revealed no significant differences in stent-related or surgical outcomes between the groups. However, regarding the gross injury score in the resected specimens, Group C had a lower score than Group NC (1.8 vs. 5.5), and the proportion of pathological tissue injury involving deeper layers was also lower in Group C (37.5% vs. 100%). Compared to conventional non-covered stents, the Kawasumi Jabara colonic stent™ demonstrated favorable safety during stent insertion, retention, and surgery, with only mild tissue injury.

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...

Novel self-expandable metallic stent with dumbbell-shape and spiral outer cover for malignant distal biliary obstruction.

Novel self-expandable metallic stent with dumbbell-shape and spiral outer cover for malignant distal biliary obstruction.

Feasibility of Double-Deployment Small-Diameter Covered Metallic Stent for Malignant Distal Biliary Obstruction (with Video)

Background/Objectives: Covered self-expandable metallic stents (CSEMS) are commonly used to treat malignant distal biliary obstructions. A 10-mm CSEMS carries the risk of obstructing the pancreatic and cystic duct orifices by adhering to the bile duct; therefore, postoperative pancreatitis and cholecystitis are reported to occur at a certain frequency. We have adopted a new drainage technique for malignant distal biliary obstruction called ‘‘double-slim SEMS stenting” (DSS), where two small-diameter CSEMS are placed side-by-side. We aimed to compare the efficacy and safety of biliary drainage using DSS with those of conventional CSEMS. Methods: In total, 50 patients who underwent endoscopic biliary drainage for malignant distal biliary obstructions between April 2019 and March 2022 at Hyogo Medical University Hospital were enrolled. Patients were divided into DSS and Conventional groups, and the technical success rate, clinical success rate, adverse events, success rate for reintervention, recurrent biliary obstruction (RBO) rate, and time to RBO (TRBO) were evaluated. Results: There were no significant differences in patient characteristics between the DSS (n = 20) and Conventional groups (n = 30). The technical and clinical success rates were 100% in the DSS group. The incidence of adverse events was not significantly different between the two groups (DSS/Conventional: 10.0% [2/20]/20.0% [6/30]) (p = 0.34). No acute cholecystitis was observed in the DSS group. The incidence rates of RBO were 30% (6/20) and 43% (13/30) in the DSS and Conventional groups, respectively (p = 0.92). The median TRBO in the DSS group was 378 days, while the TRBO in the Conventional group was 195 days (p = 0.03), resulting in significantly longer TRBO in the DSS group. Conclusions: DSS emerges as a viable and safe approach for biliary drainage in malignant distal biliary obstruction, demonstrating a lower incidence of adverse events and longer TRBO compared to conventional CSEMS.

Self-expanding metal stent for relieving the stricture after endoscopic injection for esophageal varices.

Esophageal stricture is one of the complications after esophageal varices sclerotherapy injection (ESI), and the incidence rate is between 2%-10%. To explore the efficacy of self-expanding metal stent (SEMS) for the stricture after endoscopic injection with cyanoacrylate (CYA) and sclerotherapy for esophageal varices. We retrospectively analyzed the efficacy of SEMS to improve the stricture after endoscopic injection with CYA and sclerotherapy for esophageal varices in 4 patients from February 2023 to June 2023. The strictures were improved in four patients after stenting. The stent was removed after two weeks because of chest pain with embedding into esophageal mucosa in one patient. The stent was removed after one month, however, the stent was reinserted because of the strictures happening again in two patients. The stent was removed after three months, however, the stent was reinserted because of the strictures happening again in one patient. The stent embedded into esophageal mucosa in three patients. There were 3 patients suffered reflux esophagitis, and the acid reflux was relieved by taking hydrotalcite. There was no other complication of esophageal perforation, bleeding from varices or infection. SEMS may relieve the stricture which happened after endoscopic injection with CYA and sclerotherapy for esophageal varices. However, when we should remove the stent still needs to be explored.

Radiation Exposure with Self-Expandable Metallic Stent versus Transanal Decompression Tube for Malignant Colorectal Obstruction: A Post Hoc Propensity Score Matched Analysis.

Background: Although several reports have compared the outcomes of self-expandable metallic stent (SEMSs) and transanal decompression tube (TDT) placement for malignant colorectal obstruction (MCO), few studies have compared the radiation exposure (RE) associated with these two procedures. Consequently, we aimed to compare the RE of SEMS and TDT placements for MCO using propensity score matching (PSM) in a multi-center, prospective observational study. Methods: This study investigated the clinical data of 236 patients who underwent SEMS or TDT placement. The air kerma at the patient entrance reference point (Ka,r: mGy) and air kerma-area product (PKA; Gycm2) were measured and compared between SEMS and TDT groups after PSM. Results: After PSM, 61 patients were identified in each group. The median Ka,r in the SEMS group was significantly greater than that in the TDT group (77.4 vs. 55.6 mGy; p = 0.025) across the entire cohort. With respect to subgroup analyses by location, in the rectum, the median Ka, r and PKA were significantly greater in the SEMS group than in the TDT group (172.9 vs. 34.6 mGy; p = 0.001; and 46.0 vs. 18.1 Gycm2; p = 0.006, respectively). However, in the colon, the RE parameters did not significantly differ between the two groups. Conclusions: TDT might be a more suitable option for decompression in patients with malignant rectal obstruction due to its lower RE and technical advantages. Conversely, SEMS placement is recommended as the first decompression method to treat malignant colonic obstruction, in line with the current guidelines.

Endoscopic Removal of Uncovered Metallic Airway Stents.

Self-expandable uncovered metallic stents (SEUMS) have been used in benign tracheobronchial stenosis. Stent complications may require risky removal due to SEUMS integration in the tracheobronchial wall. Our study aims to report techniques, including a novel one, and outcomes of SEUMS removal by rigid bronchoscopy. We studied a case series of 7 patients from a tertiary medical center, who underwent SEUMS removal from 2017 to 2022. SEUMS removals were performed through rigid bronchoscopy. We used a new technique with bronchoscopic hook scissors to gradually dissect the stent from the airway wall. Nine SEUMS were removed from 7 patients. The mean duration of stenting was 7 years (5 to 12y). Indications for stent removal included mostly recurrent pulmonary infections, obstructive granulation tissue, and stents' fractures. We used the usually described technique in the literature known as the "piecemeal fashion" without dissection in 4 SEUMS removals and a new dissection technique in 5 procedures. We reported one major intraoperative complication using the former technique in the form of tracheal tear with mediastinal breach, while we did not experience any major complications with the later one. One patient died 8 days after surgery from respiratory failure. Dissection and "piecemeal fashion techniques" can be used to remove SEUMS by rigid bronchoscopy even after long-term stenting. SEUMS removal is a very risky procedure and must be performed by a trained operator. Patients should be aware of possible severe complications.

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.

S1586 Covered Self-Expandable Metallic Stents versus Multiple Plastic Stents for Benign Biliary Strictures

S1586 Covered Self-Expandable Metallic Stents versus Multiple Plastic Stents for Benign Biliary Strictures

A case of successful endoscopic hemostasis with a covered self-expandable metal stent for the treatment of spurting hemobilia

A case of successful endoscopic hemostasis with a covered self-expandable metal stent for the treatment of spurting hemobilia

Safety and efficacy of conventional compared to segmented esophageal fully covered self-expanding metal stents: a retrospective multicenter case-control study.

Segmented self-expanding metal stents (SEMS) are an alternative to conventional unsegmented SEMS in the treatment of esophageal strictures. Due to their segmented design, they may adapt better to the surrounding structures making them less likely to migrate or cause trauma. We examined if there are clinically relevant differences between segmented and conventional esophageal SEMS in benign and malignant stenosis in terms of their functionality and safety. We performed a multicenter, retrospective case-control study of segmented and conventional SEMS implantations in esophageal stenosis. Outcome parameters were adverse events such as migration, occlusion, and severe complications (i.e., bleeding and perforation). 79 segmented SEMS were identified and compared to 79 conventional SEMS implantations. Groups were similar in terms of age, gender, and etiology. We observed 13.9% severe complications (SEMS-associated clinically significant bleeding or perforation) in the conventional SEMS group compared to 3.8% in the segmented SEMS group. This difference was statistically significant (p = 0.025). Rates of migration and occlusion were similar between both groups. Likewise, there was no significant difference in terms of short-term (30days) clinical success. In this first controlled analysis, segmented SEMS were associated with fewer severe clinical complications compared to conventional SEMS.