Risk factors for recurrent biliary obstruction following endoscopic biliary stenting in patients with unresectable ampullary cancer: A multicenter retrospective study.

OBJECTIVES: Unresectable ampullary cancer (AC) is a rare disease entity. The risk factors for recurrent biliary obstruction (RBO) following endoscopic biliary stenting (EBS) for unresectable AC remain unknown. In this study we aimed to evaluate the cumulative RBO rate and to identify risk factors for RBO following palliative EBS in patients with unresectable AC. METHODS: This multicenter retrospective observational study enrolled consecutive patients with unresectable AC who had undergone palliative EBS between April 2011 and December 2021. The cumulative rate of and risk factors for RBO following palliative EBS were evaluated via multivariate analysis. RESULTS: The study analysis comprised 107 patients with a median age of 84 years (interquartile range 79-88 years). Plastic stents (PSs) and self-expandable metal stents (SEMSs) were placed in 53 and 54 patients, respectively. Functional success was accomplished in 104 (97.2%) patients. Of these, RBO occurred in 62 (59.6%) patients, with obstruction and complete/partial migration occurring in 47 and 15 patients, respectively. The median time to RBO was 190 days. Multivariate analysis showed that PS was associated with a higher rate of RBO compared to SEMS (hazard ratio [HR] 2.48; P < 0.01) and that the presence of common bile duct stones/sludge immediately after EBS was an independent risk factor for RBO (HR 1.99; P = 0.04). CONCLUSIONS: The use of SEMS compared to PS during EBS reduced the time to RBO in patients with unresectable AC. Common bile duct stones/sludge immediately after EBS was a risk factor for RBO.

The use of self-expanding metallic stents in the management of benign colonic obstruction: a systematic review and meta-analysis.

INTRODUCTION: Patients presenting with large bowel obstruction (LBO) frequently undergo emergency surgery that is associated with significant morbidity. In malignant LBO, endoscopic approaches with placement is a self-expanding metal stent (SEMS), have been proposed to prevent emergency surgery and act as a bridge to an elective procedure-with the intention of avoiding a stoma and reducing morbidity. This systematic review aims to assess the quality and outcomes of data available on the use of SEMS in benign causes of colonic obstruction. METHODS: This systematic review was performed using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, and the protocol was registered on Prospero (ID: CRD42021239363). PUBMED, MEDLINE, HMIC, CINAHL, AMED, EMBASE, APA and Cochrane databases were searched. Studies were assessed for quality utilising the MINORS criteria. Pooled odds ratios with 95% confidence intervals (95% CI) were calculated using random effects models. RESULTS: Sixteen studies were included for analysis. 300 patients were included with an average age of 68, and a male predominance of 57%. The quality of the papers included were at risk of bias. The pooled rate of technical success of procedure was 94.4% (95% CI 90.5-96.8%) The pooled rate of clinical success was 77.6% (95% CI: 66.6-85.7%). Adverse effects were low, with perforation 8.8% (4.5-16.6%), recurrence 26.5% (17.2-38.5%) and stent migration 22.5% (14.1-33.8%). DISCUSSION: This systematic review demonstrated that SEMS for benign colonic obstruction can be a safe and successful procedure. The utilisation of SEMS in malignant disease as a bridge to surgery has been well documented. Whilst the limitations of the data interpreted are appreciated, we postulate that SEMS could be utilised to decompress patients acutely and allow pre-operative optimisation, leading to a more elective surgery with less subsequent morbidity.

Comparison of the clinical effectiveness of hepaticojejunostomy and self-expanding metal stents for bypassing the bile ducts in patients with unresectable pancreatic head cancer complicated by obstructive jaundice.

OBJECTIVE: Aim: To improve treatment outcomes of patients with unresectable pancreatic head cancer complicated by obstructive jaundice by improving the tactics and techniques of surgical interventions. PATIENTS AND METHODS: Materials and Methods: Depending on the treatment tactics, patients were randomised to the main group (53 people) or the comparison group (54 people). The results of correction of obstructive jaundice by Roux-en-Y end to side hepaticojejunostomy (main group) and common bile duct prosthetics with self-expanding metal stents (comparison group) were compared. RESULTS: Results: The use of self-expanding metal stents for internal drainage of the biliary system compared to hepaticojejunostomy operations reduced the incidence of postoperative complications by 29.9% (χ2=13.7, 95% CI 14.38-44.08, p=0.0002) and mortality by 7.5% (χ2=4.16, 95% CI -0.05-17.79, p=0.04). Within 8-10 months after biliary stenting, 11.1% (6/54) of patients developed recurrent jaundice and cholangitis, and another 7.4% (4/54) of patients developed duodenal stenosis with a tumour. These complications led to repeated hospitalisation and biliary restentation in 4 (7.4%) cases, and duodenal stenting by self-expanding metal stents in 4 (7.4%) patients. CONCLUSION: Conclusions: The choice of biliodigestive shunting method should be selected depending on the expected survival time of patients. If the prognosis of survival is up to 8 months, it is advisable to perform prosthetics of the common bile duct with self-expanding metal stents, if more than 8 months, it is advisable to perform hepaticojejunal anastomosis with prophylactic gastrojejunal anastomosis.

Long-Term Outcomes of the Self-Expandable Metallic Stent as a Bridge to Surgery versus Elective Surgery without Stent Placement for Colorectal Cancer: A Retrospective Cohort Study.

BACKGROUND: The uncertainty surrounding whether delaying surgery after self-expandable metal stent (SEMS) placement for neoplastic stricture can yield similar oncologic outcomes as elective surgery remains. This study aims to investigate the impact of elective surgery following SEMS placement for obstructive colorectal cancer (OCC) on patients. METHODS: Patients diagnosed with stage I to III colorectal cancer (CRC) were recruited and randomly allocated into two groups: group A, receiving elective surgery after SEMS placement for obstructive colon cancer, and group B, undergoing elective surgery for non-obstructive colorectal cancer. Following a 1:2 matching process based on age, gender, tumor location, tumor depth, pathological stage, and adjuvant chemotherapy, group A comprised 95 patients, while group B consisted of 190 patients for comparative analysis. RESULTS: The 5-year disease-free survival (DFS) rate and overall survival (OS) rate were worse in group A (62.3% vs. 70.9%, p = 0.086) and (65.6% vs. 75.8%, p = 0.093) compared with group B, although these differences were not statistically significant. This discrepancy in long-term oncologic outcomes did not reach significance when the analysis was stratified by tumor perineural invasion (PNI) status. Univariate analysis revealed that SEMS placement was not a poor prognostic factor for DFS (p = 0.086). CONCLUSIONS: Elective surgery for obstructive colorectal cancer (OCC) following SEMS placement may exhibit poorer long-term oncologic outcomes compared to elective surgery for non-obstructive colorectal cancer, particularly due to the higher rate of PNI associated with OCC. Upon stratification of patients in each group by PNI status, the observed differences became marginal.

Evaluation of short and mid-term clinical outcomes in patients with aortic coarctation treated with self-expandable stents.

The present study aimed to evaluate the outcomes of percutaneous treatment of aortic coarctation using self-expandable uncovered Nitinol stents. We conducted a retrospective clinical data review of all patients with aortic coarctation and treated with self-expandable uncovered Nitinol stents at our institution between 2009 and 2019. The gradient pressure across the coarctation site was measured using aortography. Follow-up echocardiography and computed tomography angiography were performed to assess possible stent complications. A total of 127 stents were successfully implanted in 125 patients (64.8% males) with a mean age of 35.36 ± 11.9 years. The gradient across the coarctation site decreased significantly from 67.48 ± 14.79 to 5.04 ± 3.01 mmHg (P < 0.001) after self-expandable stent implantation. Systolic blood pressure (SBP) decreased significantly from 175.53 ± 15.99 to 147.22 ± 12.83 mmHg (P < 0.001) after self-expandable stenting. There were no major technical or clinical complications, including balloon rupture, aneurysmal formation, infection, secondary stent migration, thrombosis, death during the procedure, and in-hospital mortality. On a mean follow-up of 48 ± 23.6 months (12-120 months), the gradient [from 59.43 ± 15.42 to 3.72 ± 1.38 mmHg (P < 0.001)] and SBP [from 175.53 ± 15.99 to 127.99 ± 7.82 mmHg (P < 0.001)] decreased significantly. There was no mortality, aneurysmal formation in the stent site, dislocation, or aortic re-stenosis requiring intervention during mid-term follow-up. Treatment of aortic coarctation using a self-expandable uncovered nitinol stent is safe and effective with promising mid-term outcomes.

Management Strategies for Malignant Left-Sided Colonic Obstruction: A Systematic Review and Network Meta-analysis of Randomized Controlled Trials and Propensity Score Matching Studies.

BACKGROUND: The optimal treatment strategy for left-sided malignant colonic obstruction remains controversial. Emergency colonic resection has been the standard of care; however, self-expanding metallic stenting as a bridge to surgery may offer short-term advantages, although oncological concerns exist. Decompressing stoma may provide a valid alternative, with limited evidence. OBJECTIVE: To perform a systematic review and Bayesian arm random-effects model network meta-analysis comparing the approaches for management of malignant left-sided colonic obstruction. DATA SOURCES: A systematic review of PubMed, Embase, Cochrane Library, and Google Scholar databases was conducted from inception to August 22, 2023. STUDY SELECTION: Randomized controlled trials and propensity score-matched studies. INTERVENTIONS: Emergency colonic resection, self-expanding metallic stent, and decompressing stoma. MAIN OUTCOME MEASURES: Oncologic efficacy, morbidity, successful minimally invasive surgery, primary anastomosis, and permanent stoma rates. RESULTS: Nineteen of 5225 articles identified met our inclusion criteria. Stenting (risk ratio 0.57; 95% credible interval, 0.33-0.79) and decompressing stomas (risk ratio 0.46, 95% credible interval: 0.18-0.92) resulted in a significant reduction in the permanent stoma rate. Stenting facilitated minimally invasive surgery more frequently (risk ratio 4.10; 95% credible interval, 1.45-13.13) and had lower overall morbidity (risk ratio 0.58; 95% credible interval, 0.35-0.86). A pairwise analysis of primary anastomosis rates showed increased stenting (risk ratio 1.40; 95% credible interval, 1.31-1.49) compared with emergency resection. There was a significant decrease in the 90-day mortality with stenting (risk ratio 0.63; 95% credible interval, 0.41-0.95) compared with resection. There were no differences in disease-free and overall survival rates, respectively. LIMITATIONS: There is a lack of randomized controlled trials and propensity score matching data comparing short-term and long-term outcomes for diverting stomas compared to self-expanding metallic stents. Two trials compared self-expanding metallic stents and diverting stomas in left-sided malignant colonic obstruction. CONCLUSIONS: This study provides high-level evidence that a bridge-to-surgery strategy is safe for the management of left-sided malignant colonic obstruction and may facilitate minimally invasive surgery, increase primary anastomosis rates, and reduce permanent stoma rates and postoperative morbidity compared with emergency colonic resection.

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.

BACKGROUND AND AIMS: 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. METHODS: 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. RESULTS: 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 3.1 months (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 57.9 months (IQR 51.9-64.3). Stricture recurrence occurred in 3 of 26 patients who achieved clinical success (11.5%). CONCLUSIONS: FCSEMS placement appears to be an effective and advisable intervention for refractory ABS as it can provide persistent stricture improvement over the long-term.

Risk factors for migration of retrievable covered expandable metallic stent in patients with persistent benign ureter strictures.

PURPOSE: The purpose of this study is to evaluate the incidence, risk factors, and salvage management of retrievable covered expandable metallic stent (RCEMS) migration in patients with persistent benign ureter strictures. MATERIALS AND METHODS: A retrospective study was performed on 117 consecutive patients who underwent implantation of RCEMS. Univariate and multivariate analyses were used to identify prognostic factors for stent migration, including stricture location and length, hydronephrosis-cortex ratio, ureteral dilation, and the diameter of the narrowest portion of the stricture. RESULTS: Stent migration occurred in 22 (19.5%) of 113 patients who met inclusion criteria. Of the 22 patients, 16 (72.7%) had ordinary ureteral stricture, 3 (13.6%) had stricture in transplanted kidneys, and 3 patients (13.6%) had ureter stricture in orthotopic neobladders. The mean creatinine for the entire cohorts showed significant improvement (p = 0.038). Multivariate analysis identified the following prognostic factors for migration: distal ureteral stricture (p = 0.006), patients who underwent balloon dilation (p = 0.003), hydronephrosis-cortex ratio ≧10 (p = 0.017), larger diameter of wasting of RCEMS (p < 0.001), and patients with a shorter stricture length (p = 0.006). Salvage management was required in 4 of the 22 patients. The strictures in the remaining 18 patients improved with observation. CONCLUSIONS: Stent migration is more likely to occur in patients with the five prognostic factors mentioned above. Our study developed a nomogram to predict stent migration in patients with ureteral strictures treated using RCEMS.

Prótesis colónicas en el tratamiento paliativo del cáncer colónico. Nuestra evaluación tras 10 años de experiencia / Self-expanding metal stents in the palliative treatmentof coloncancer. Results of 10 years of experience

Introducción: la colocación de prótesis metálicas autoexpansibles (PAE) por vía endoscópica surge como opción terapéutica para la obstrucción colónica neoplásica en dos situaciones: como tratamiento paliativo y como puente a la cirugía curativa. Este procedimiento evita cirugías en dos tiempos y disminuye la probabilidad de colostomía definitiva y sus complicaciones con el consecuente deterioro de la calidad de vida. Objetivo: comunicar nuestra experiencia en la colocación de PAE para el tratamiento paliativo de la obstrucción colorrectal neoplásica. Diseño: retrospectivo, longitudinal, descriptivo y observacional. Material y métodos: se incluyeron todos los pacientes a quienes el mismo grupo de endoscopistas les colocó PAE con intención paliativa por cáncer colorrectal avanzado entre agosto de 2008 y diciembre de 2019. Fueron analizadas las variables demográficas y clínicas, el éxito técnico y clínico, las complicaciones tempranas y tardías y la supervivencia. Resultados: se colocó PAE en 54 pacientes. La media de edad fue 71 años. El 85% de las lesiones se localizó en el colon izquierdo. En el 57% de los pacientes se realizó en forma ambulatoria. El éxito técnico y clínico fue del 92 y 90%, respectivamente y la supervivencia media de 209 días. La tasa de complicaciones fue del 29,6%, incluyendo un 14,8% de obstrucción y un 5,6% de migración. La mortalidad tardía atribuible al procedimiento fue del 5,6%, ocasionada por 3 perforaciones tardías: 2 abiertas y 1 microperforación con formación de absceso localizado. Conclusiones: la colocación de PAE como tratamiento paliativo de la obstrucción neoplásica colónica es factible, eficaz y segura. Permitió el manejo ambulatorio o con internación breve y la realimentación temprana, mejorando las condiciones para afrontar un eventual tratamiento quimioterápico paliativo. Las mayoría de las complicaciones fueron tardías y resueltas endoscópicamente en forma ambulatoria. (AU)

Introduction: endoscopic placement of self-expanding metal stents (SEMS) emerges as a therapeutic option for neoplastic obstruction of the colon in two situations: as palliative treatment and as a bridge to curative surgery. This procedure avoids two-stage surgeries and reduces the probability of permanent colostomy and its complications with the consequent deterioration in quality of life. Objective: to report our experience in the placement of SEMS as palliative treatment in neoplastic colorectal obstruction. Design: retrospective, longitudinal, descriptive and observational study. Methods: all patients in whom the same group of endoscopists performed SEMS placement with palliative intent for advanced colorectal cancer between August 2008 and December 2019 were analyzed. Data collected were demographic and clinical variables, technical and clinical success, early and late complications, and survival. Results: SEMS were placed in 54 patients. The average age was 71 years. Eighty-five percent were left-sided tumors. In 57% of the patients the procedure was performed on an outpatient basis. Technical and clinical success was 92 and 90%, respectively, and median survival was 209 days. The complication rate was 29.6%, including 14.8% obstruction and 5.6% migration. Late mortality attributable to the procedure was 5.6%, caused by 3 late perforations: 2 open and 1 microperforation with localized abscess formation. Conclusions: The placement of SEMS as a palliative treatment for neoplastic colonic obstruction is feasible, effective and safe. It allowed outpa-tient management or brief hospitalization and early refeeding, improving the conditions to face an eventual palliative chemotherapy treatment. Most complications were late and resolved endoscopically on an outpatient basis. (AU)

Risk factors and treatment strategies for cholecystitis after metallic stent placement for malignant biliary obstruction: a multicenter retrospective study.

BACKGROUND AND AIMS: Cholecystitis can occur after self-expandable metallic stent (SEMS) placement for malignant biliary obstruction (MBO), but the best treatment option for cholecystitis has not been determined. Here, we aimed to identify the risk factors of cholecystitis after SEMS placement and determine the best treatment option. METHODS: Incidence, treatments, and predictive factors of cholecystitis were retrospectively evaluated in 1084 patients with distal MBO (DMBO) and 353 patients with hilar MBO (HMBO) who underwent SEMS placement at 12 institutions from January 2012 to March 2021. RESULTS: Cholecystitis occurred in 7.5% of patients with DMBO and 5.9% of patients with HMBO. The recurrence rate was significantly lower (P = .043) and the recurrence-free period significantly longer (P = .039) in endoscopic procedures than in percutaneous procedures for cholecystitis treatment. EUS-guided gallbladder drainage (EUS-GBD) was better in terms of technical success, procedure time, and recurrence-free period than endoscopic transpapillary gallbladder drainage. Obstruction across the cystic duct orifice by tumor (P = .015) and by stent (P = .037) were independent risk factors for cholecystitis in DMBO. Cases with multiple SEMS placements (odds ratio [OR], 11; 95% confidence interval [CI], 0.68-190; P = .091) and with gallbladder stones (OR, 2.3; 95% CI ,0.92-5.6; P = .075) had a higher risk for cholecystitis in HMBO. CONCLUSIONS: The incidences of cholecystitis after SEMS placement for DMBO and HMBO were similar. EUS-GBD is the optimal treatment option for patients with cholecystitis after SEMS placement for MBO.

Self-expandable metallic stents may be more efficient than balloon dilatation alone for esophageal stricture after circumferential endoscopic submucosal dissection: a retrospective cohort study in China.

INTRODUCTION: Self-expandable metallic stents (SEMSs) can be used to treat esophageal stricture after circumferential endoscopic submucosal dissection (ESD), but its efficacy and placement timing remain to be determined. In this study, the treatment time and number of dilatations were compared between the SEMS placement group and the balloon dilatation (BD) group to clarify the efficacy and placement time of SEMSs in the treatment of esophageal stricture after circumferential esophageal ESD. METHODS: This was a retrospective cohort study. Patients with esophageal stricture after circumferential ESD between January 2015 and January 2020 were included. Data on the patients' demographic characteristics, esophageal lesion-related factors, esophageal stricture occurrence, and measures taken to treat the stricture were collected. The primary outcome was the treatment time, and the secondary outcome was the number of dilatations. RESULTS: The total number of dilatations was 30 in the SEMS group and 106 in the BD group. The average number of dilatations in the SEMS group (1.76 ± 1.64) was significantly lower than that in the BD group (4.42 ± 5.32) (P = 0.016). Among the patients who underwent SEMS placement first had a shorter treatment time (average 119 days) than those who underwent BD first (average 245 days) (P = 0.041), and the average number of dilatations inpatients who underwent SEMS placement first (0.71 ± 1.07) was significantly lower than that in the patients who underwent BD first (2.5 ± 1.54). CONCLUSION: SEMSs were more efficient in the treatment of esophageal stricture in a cohort of patients after circumferential esophageal ESD.

Endoscopic self-expandable metal stent versus endoscopy vacuum therapy for traumatic esophageal perforations: a retrospective cohort study.

BACKGROUND: Traumatic esophageal perforations (TEP) are a grave medical condition and require immediate intervention. Techniques such as Esophageal Self-Expandable Metal Stent (E-SEMS) and Endoscopic Vacuum Therapy (EVT) show promise in reducing tissue damage and controlling esophageal leakage. The present study aims to compare the application of EVT to E-SEMS placement in TEP. METHODS: Retrospective cohort study valuated 30 patients with TEP. The E-SEMS and EVT groups were assessed for time of hospitalization, treatment duration, costs, and clinical outcome. RESULTS: Patients treated with EVT (24.4 ± 13.2) demonstrated significantly shorter treatment duration (p < 0.005) compared to the group treated with E-SEMS (45.8 ± 12.9) and patients submitted to E-SEMS demonstrated a significant reduction (p = 0.02) in the time of hospitalization compared to the EVT (34 ± 2 vs 82 ± 5 days). Both groups demonstrated a satisfactory discharge rate (E-SEMS 93.7% vs EVT 71.4%) but did not show statistically significant difference (p = 0.3155). E-SEMS treatment had a lower mean cost than EVT (p < 0.05). Descriptive statistics were utilized, arranged in table form, where frequencies, percentages, mean, median, and standard deviation of the study variables were calculated and counted. The Fisher's Exact Test was used to evaluate the relationship between two categorical variables. To evaluate differences between means and central points, the parametric t-test was utilized. Comparisons with p value up to 0.05 were considered significant. CONCLUSION: E-SEMS showed a shorter time of hospitalization, but a longer duration of treatment compared to EVT. The placement of E-SEMS and EVT had the same clinical outcome. Treatment with E-SEMS had a lower cost compared with EVT.

Shape-Setting of Self-Expanding Nickel-Titanium Laser-Cut and Wire-Braided Stents to Introduce a Helical Ridge.

PURPOSE: Altered hemodynamics caused by the presence of an endovascular device may undermine the success of peripheral stenting procedures. Flow-enhanced stent designs are under investigation to recover physiological blood flow patterns in the treated artery and reduce long-term complications. However, flow-enhanced designs require the development of customised manufacturing processes that consider the complex behaviour of Nickel-Titanium (Ni-Ti). While the manufacturing routes of traditional self-expanding Ni-Ti stents are well-established, the process to introduce alternative stent designs is rarely reported in the literature, with much of this information (especially related to shape-setting step) being commercially sensitive and not reaching the public domain, as yet. METHODS: A reliable manufacturing method was developed and improved to induce a helical ridge onto laser-cut and wire-braided Nickel-Titanium self-expanding stents. The process consisted of fastening the stent into a custom-built fixture that provided the helical shape, which was followed by a shape-setting in air furnace and rapid quenching in cold water. The parameters employed for the shape-setting in air furnace were thoroughly explored, and their effects assessed in terms of the mechanical performance of the device, material transformation temperatures and surface finishing. RESULTS: Both stents were successfully imparted with a helical ridge and the optimal heat treatment parameters combination was found. The settings of 500 °C/30 min provided mechanical properties comparable with the original design, and transformation temperatures suitable for stenting applications (Af = 23.5 °C). Microscopy analysis confirmed that the manufacturing process did not alter the surface finishing. Deliverability testing showed the helical device could be loaded onto a catheter delivery system and deployed with full recovery of the expanded helical configuration. CONCLUSION: This demonstrates the feasibility of an additional heat treatment regime to allow for helical shape-setting of laser-cut and wire-braided devices that may be applied to further designs.