Biliary Metal Stents Research Articles

Technical challenges and safety of prophylactic gallbladder stenting with metallic biliary stenting.

Technical challenges and safety of prophylactic gallbladder stenting with metallic biliary stenting.

Biliary drainage in patients with malignant distal biliary obstruction: results of an Italian consensus conference

BackgroundMalignant Distal Biliary Obstruction (MBDO) is a common event occurring along the natural history of both pancreatic cancer and cholangiocarcinoma. Epidemiological and biological features make MBDO one of the key elements of the clinical management of patients suffering for of pancreatic cancer or cholangiocarcinoma. The development of dedicated biliary lumen-apposing metal stents (LAMS) is changing the clinical work up of patients with MBDO. i-EUS is an Italian network of clinicians and scientists with a special interest in biliopancreatic endoscopy, EUS in particular.MethodsThe scientific methodology was chosen in line with international guidance and in a fashion similar to those applied by broader scientific associations. PICO questions were elaborated and subsequently voted by a broad panel of experts within a simplified Delphi process.Results and conclusionsThe manuscripts describes the results of a consensus conference organized by i-EUS with the aim of providing an evidence based-guidance for the appropriate use of the techniques in patients with MBDO.

Case report of rare cause of small bowel obstruction: distal migration of metal biliary stent requiring enterotomy

Endoscopic biliary stent placement is a mainstay in the management of biliary strictures both malignant and benign. Distal stent migration is a known complication of metal biliary stents, however small bowel obstruction or perforation are rare. In this report from a tertiary referral centre, we detail a mid-small bowel obstruction caused by covered metal stent migration requiring a laparotomy and enterotomy for definitive management. A 69-year-old male was admitted to the Sunshine Coast University Hospital with obstructive jaundice on a background of previous metal biliary stent placement. On day 3 of his admission, he developed worsening abdominal pain. Cross-sectional imaging demonstrated distal migration of his stent to his mid-jejunum, causing a high-grade small bowel obstruction. He underwent laparotomy to retrieve the stent. He recovered well and underwent a percutaneous transhepatic cholangiogram with stent replacement. In this case, distal biliary stent migration causes a small bowel obstruction. Whilst uncommon, risk factors including previous intra-abdominal operation can be used to identify patients unlikely to achieve successful expectant management of distal migration.

Safety and efficacy of biliary suprapapillary metal and plastic stents in malignant biliary obstruction: a systematic review and meta-analysis.

Biliary drainage is vital in managing malignant biliary obstruction (MBO). Suprapapillary stenting has emerged as a viable alternative to transpapillary stenting and is performed using inside plastic (iPS) or metal stents (iMS). This meta-analysis aims to evaluate the outcomes of suprapapillary stent placement for MBO. The Embase, PubMed, and Web of Science databases were systematically searched to include all studies published before September 31, 2023, that reported on the outcomes of suprapapillary stents placed for MBO. Using the random-effect model, the pooled, weight-adjusted event rate estimate for the clinical outcomes was calculated with 95% confidence intervals (CIs). Twenty-eight studies were included, with a total of 1401 patients. The pooled clinical success rate was 98.9%. A subgroup analysis yielded non-significant differences between the iPS and iMS groups (99.3% vs. 98.6%, respectively; P = 0.44). The pooled incidence rate of adverse events (AE) with suprapapillary stents was 9.5%. In a subgroup analysis, the incidence of AEs with iPS was 10.7% compared to 9% in the iMS group without a statistical difference (P = 0.32). The most common adverse event was cholangitis (2.2%), followed by pancreatitis (1.1%), cholecystitis (0.5%), and bleeding (0.12%). When technically feasible, suprapapillary stenting for MBO is a viable endoscopic option with a high clinical success rate and acceptable adverse event rates. Both iPS and iMS exhibit similar efficacy.

Computed tomography-based prediction of pancreatitis following biliary metal stent placement with the convolutional neural network.

Background and study aims Pancreatitis is a potentially lethal adverse event of endoscopic transpapillary placement of a self-expandable metal stent (SEMS) for malignant biliary obstruction (MBO). Deep learning-based image recognition has not been investigated in predicting pancreatitis in this setting. Patients and methods We included 70 patients who underwent endoscopic placement of a SEMS for nonresectable distal MBO. We constructed a convolutional neural network (CNN) model for pancreatitis prediction using a series of pre-procedure computed tomography images covering the whole pancreas (≥ 120,960 augmented images in total). We examined the additional effects of the CNN-based probabilities on the following machine learning models based on clinical parameters: logistic regression, support vector machine with a linear or RBF kernel, random forest classifier, and gradient boosting classifier. Model performance was assessed based on the area under the curve (AUC) in the receiver operating characteristic analysis, positive predictive value (PPV), accuracy, and specificity. Results The CNN model was associated with moderate levels of performance metrics: AUC, 0.67; PPV, 0.45; accuracy, 0.66; and specificity, 0.63. When added to the machine learning models, the CNN-based probabilities increased the performance metrics. The logistic regression model with the CNN-based probabilities had an AUC of 0.74, PPV of 0.85, accuracy of 0.83, and specificity of 0.96, compared with 0.72, 0.78, 0.77, and 0.96, respectively, without the probabilities. Conclusions The CNN-based model may increase predictability for pancreatitis following endoscopic placement of a biliary SEMS. Our findings support the potential of deep learning technology to improve prognostic models in pancreatobiliary therapeutic endoscopy.

Implementation of Best Practices in Pancreatic Cancer Care in the Netherlands: A Stepped-Wedge Randomized Clinical Trial.

Implementation of new cancer treatment strategies as recommended by evidence-based guidelines is often slow and suboptimal. To improve the implementation of guideline-based best practices in the Netherlands in pancreatic cancer care and assess the impact on survival. This multicenter, stepped-wedge cluster randomized trial compared enhanced implementation of best practices with usual care in consecutive patients with all stages of pancreatic cancer. It took place from May 22, 2018 through July 9, 2020. Data were analyzed from April 1, 2022, through February 1, 2023. It included all patients in the Netherlands with pathologically or clinically diagnosed pancreatic ductal adenocarcinoma. This study reports 1-year follow-up (or shorter in case of deceased patients). The 5 best practices included optimal use of perioperative chemotherapy, palliative chemotherapy, pancreatic enzyme replacement therapy (PERT), referral to a dietician, and use of metal stents in patients with biliary obstruction. A 6-week implementation period was completed, in a randomized order, in all 17 Dutch networks for pancreatic cancer care. The primary outcome was 1-year survival. Secondary outcomes included adherence to best practices and quality of life (European Organisation for Research and Treatment of Cancer [EORTC] global health score). Overall, 5887 patients with pancreatic cancer (median age, 72.0 [IQR, 64.0-79.0] years; 50% female) were enrolled, 2641 before and 2939 after implementation of best practices (307 during wash-in period). One-year survival was 24% vs 23% (hazard ratio, 0.98, 95% CI, 0.88-1.08). There was no difference in the use of neoadjuvant chemotherapy (11% vs 11%), adjuvant chemotherapy (48% vs 51%), and referral to a dietician (59% vs 63%), while the use of palliative chemotherapy (24% vs 30%; odds ratio [OR], 1.38; 95% CI, 1.10-1.74), PERT (34% vs 45%; OR, 1.64; 95% CI, 1.28-2.11), and metal biliary stents increased (74% vs 83%; OR, 1.78; 95% CI, 1.13-2.80). The EORTC global health score did not improve (area under the curve, 43.9 vs 42.8; median difference, -1.09, 95% CI, -3.05 to 0.94). In this randomized clinical trial, implementation of 5 best practices in pancreatic cancer care did not improve 1-year survival and quality of life. The finding that most patients received no tumor-directed treatment paired with the poor survival highlights the need for more personalized treatment options. ClinicalTrials.gov Identifier: NCT03513705.

Through-the-cholangioscope metal biliary stent placement as a novel endoscopic technique for bile duct strictures.

Through-the-cholangioscope metal biliary stent placement as a novel endoscopic technique for bile duct strictures.

A comprehensive analysis of reported adverse events with biliary self-expandable metal stents: an FDA MAUDE database study

A comprehensive analysis of reported adverse events with biliary self-expandable metal stents: an FDA MAUDE database study

Simple use of Y-connector for proper positioning and contrast aspiration in biliary metal stent placement.

Simple use of Y-connector for proper positioning and contrast aspiration in biliary metal stent placement.

Sems Sensibility: Biliary Stent Migration into the Oesophagus.

Endoprostheses are commonly used in the treatment of biliary and pancreatic disorders. Fully-covered metal stents are intended for the palliation of malignant strictures in the biliary tree.We report a case of a patient affected by cancer of the pancreas who was treated with a proximal metallic biliary stent. The stent migrated to the oesophagus and was endoscopically removed. Proximal migration, although rare, should be kept in mind as a potential complication of the procedure.

Clinical use of uncovered balloon-expandable metallic biliary stents for treatment of extrahepatic biliary tract obstructions in cats and dogs: 11 cases (2012-2022).

To describe the application of uncovered balloon-expandable metallic biliary stents for treatment of extrahepatic biliary obstructions (EHBOs) and the outcomes for dogs and cats treated for EHBO with this technique. Retrospective single institutional study. Eight dogs and three cats treated at the Veterinary Specialty Hospital of San Diego for EHBO between January 2012 and February 2022. Data collected from the medical records included signalment, presenting complaint, laboratory and imaging findings, surgical findings, hospitalization time, complications, and follow-up information. Median duration of short-term follow up was 16 days (6-45 days). Improved biochemical abnormalities and resolution of clinical signs were recorded in 10/11 cases. Two dogs died within 2 weeks of surgery. One dog developed systemic inflammatory response syndrome 5 days postoperatively and was euthanized; the cause of death in the second case was unknown. Long-term follow up was available in seven cases, with a median duration of 307.5 days (62-2268 days). Bile-duct patency was maintained for at least 356-622 days (median: 446 days) in three cats and 62-2268 days (median: 650.5 days) in four dogs with long-term follow up available. One cat had recurrent obstruction with choledocholiths 446 days postoperatively. One stent was removed 614 days postoperatively due to recurrent cholangiohepatitis. Uncovered balloon-expandable metallic biliary stents were placed successfully and relieved EHBO in all cases that survived to discharge. Use of uncovered balloon-expandable metallic biliary stents should be considered as an alternative to temporary choledochal luminal stenting or cholecystoenterostomy to manage EHBO.

Successful removal of a biliary metal stent using the stent-in-stent-in-stent technique.

Successful removal of a biliary metal stent using the stent-in-stent-in-stent technique.

Pain and Palliative Management in Advanced Gastrointestinal Malignancies – How Are We Doing?

Aims: The aim of the study is to study the different methods and their efficacy in pain management in advanced gastrointestinal (GI) malignancies. Methods: The study included patients with advanced and inoperable GI malignancies. Demographic data, laboratory parameters and radiological investigations, baseline visual analog scale (VAS) score, and subjective global assessment (SGA) were recorded on the first contact along with details of medical, endoscopic, and palliative interventions as performed. Analgesic pain step ladder approach was followed for pain management. Follow-up to assess response was done using VAS score and SGA at the end of 3 months or death within this period. Results: Seventy-one patients were included. Most of them were elderly males. Out of 7 malignancies noted, hepatocellular carcinoma (HCC) was the most common tumor (41; 57.8%). Thirty-five patients (49.3%) had vascular invasion, while 29 (40.8%) had metastatic cancer. The most common vascular invasion was the portal vein (29; 40.8%). The liver was the most common metastatic site (12; 16.9%). The baseline mean VAS score was 5.13 ± 2.38 and the highest was in carcinoma gallbladder patients (8.0 ± 2.0). Most patients were having baseline SGA rating B (69%). Tramadol was the most commonly used analgesic (35.22%) followed by a combination of tramadol and fentanyl (26.76%). The most common palliation was transarterial chemoembolization in HCC (80.5%) and biliary self-expandable metallic stent in carcinoma pancreas (77.8%). There was a statistically significant reduction in VAS score in HCC (P < 0.001), carcinoma pancreas (P = 0.009), and colorectal cancer (P = 0.022). One-sixth patients moved from SGA rating B to rating A, 9.9% moved from SGA rating B to rating C, and 9.9% moved from SGA rating C to rating B. Conclusion: There was an improvement in quality of life at 3-month follow-up. There was significant pain improvement in the studied patients. However, almost one-third patients did not get adequate pain relief.

Endoscopic ultrasound-guided reintervention for biliary metal stent kinking using a device delivery system.

Endoscopic ultrasound-guided reintervention for biliary metal stent kinking using a device delivery system.

Drainage of Afferent Limb Obstruction via the Trans-gastric-bile Duct Formed after Endoscopic Ultrasound-guided Hepaticogastrostomy in a Patient with Pancreatic Cancer.

A 63-year-old man with advanced pancreatic cancer and pyloric obstruction underwent surgical gastrojejunostomy. Malignant biliary obstruction appeared eight months after surgery and was managed with endoscopic ultrasound (EUS)-guided hepaticogastrostomy (HGS). Subsequently, afferent limb obstruction caused by cancer invasion occurred. Although an intestinal metal stent could not be placed, a biliary metal stent was deployed via the HGS route, which successfully decompressed the afferent limb; the abdominal symptoms subsequently disappeared. In future similar cases, decompression of the dilated intestine through the HGS and biliary stent might be a viable treatment option.

Biliary self-expandable metallic stent combined with iodine-125 seeds in the treatment of malignant biliary obstruction (Bismuth type I or II).

The purpose of this research was to evaluate the safety and efficacy of a self-expandable metallic stent (SEMS) combined with iodine-125 (125I) seeds in the treatment of Bismuth type I or II malignant biliary obstruction (MBO). The clinical data of 74 cases of MBO treated with percutaneous SEMS combined with 125I seeds (combination group) and 81 cases of MBO treated with SEMS implantation alone (control group) in our hospital from January 2015 to December 2019 were retrospectively analyzed. The short-term and long-term efficacy of the two groups were compared. Multivariate Cox regression analysis was used to analyze the factors affecting the surgical efficacy and survival rate. The liver blood test results of both groups improved at one week and one month post-stent insertion. No significant difference was established in the short-term efficacy or complications between the two groups (P = NS). Improved stent patency was observed in the combined group, 9.01 ± 4.38months versus 6.79 ± 3.13months, respectively (P < 0.001). Improved survival was also noted in the combined group 12.08 ± 5.38months and 9.10 ± 4.16months, respectively (P < 0.001). Univariate and multivariate analyses showed that the type of biliary stent and liver metastasis were independent factors affecting survival. The implementation of SEMS combined with 125I seeds resulted in significantly longer stent patency and survival times than that of SEMS implantation alone, which is thus worthy of clinical promotion and application.

Nationwide implementation of best practices in pancreatic cancer care (PACAP-1): Stepped-wedge cluster randomized trial.

4152 Background: Implementation of new treatment strategies in cancer care is often inadequate and slow. We aimed to implement best practices in pancreatic cancer care using a nationwide stepped wedge design and assess the impact on overall survival. Methods: Nationwide multicenter stepped-wedge cluster randomized controlled trial comparing implementation of best practices with usual care (May 22, 2018 – May 29, 2020). Best practices included adequate use of perioperative and palliative chemotherapy, pancreatic enzyme replacement therapy (PERT), and metal biliary stents. The 6-week implementation period in all 17 Dutch pancreatic centers and their regional referral networks included monitoring, return visits, and provider feedback in combination with education and reminders. Primary outcome was one-year overall survival for all disease stages and secondary outcomes included guideline compliance and quality of life. Results: Overall, 5580 patients diagnosed with pancreatic cancer were included; 2939 after implementation of best practices versus 2641 before. One-year survival did not differ among the groups (HR 0.98, 95 CI 0.88-1.08). Overall use of perioperative chemotherapy (neoadjuvant and adjuvant) did not significantly differ, but use of palliative chemotherapy significantly increased (23.9% to 30.3%, OR 1.38, 95 CI 1.10-1.74). Also the use of PERT (34.2% to 45.2%, OR 1.64, 95 CI 1.28-2.11); and metal biliary stents (74.1.% to 83.3%, OR 1.78, 95 CI 1.13-2.08) significantly increased. The Global Health Score did not differ (AUC 43.8 to 42.7, median difference -1.12, 95 CI -3.13-0.80, n=655). Conclusions: This nationwide population-based trial to enhance implementation of best practices in pancreatic cancer care showed successful implementation of most best practices, but no increase in one-year survival and quality of life. Clinical trial information: NCT03513705 .

Short and long outcomes of endoscopic bilateral metal stent placement for malignant hilar biliary obstruction: Tertiary care oncology centre experience.

Placement of biliary self-expanding metal stents (SEMS) has been effective for palliation of unresectable hilar malignant biliary obstruction. Optimal drainage in hilar obstruction may require placement of multiple stents. Data on multiple SEMS placement in hilar obstruction from India is sparse. Retrospective review of patients with unresectable malignant hilar obstruction who underwent endoscopic bilateral SEMS insertion from 2017 to 2021 was done. Demographic details, technical success and functional success (decrease in the bilirubin value below 3mg/dL at fourweeks), immediate complications with 30-days mortality, requirement of re-intervention, stent patency and overall survival were studied. Forty-three patients were included (mean age 54.9years, 51.2% females). Thirty-six patients (83.7%) had carcinoma gallbladder as primary malignancy. Twenty-six patients (60.5%) were metastatic at presentation. Cholangitis was seen in 4/43 (9.3%). On cholangiogram, 26 (60.4%) had Bismuth type II block, 12 (27.8%) had type IIIA/B, 5 (11.6%) had type IV block. Technical success was achieved in 41/43 (95.3%) patients (38, side-by-side SEMS placement; 3, SEMS-within-SEMS in Y fashion). Functional success was achieved in 39 patients (95.1%). No moderate-severe complications were reported. Median post-procedure hospitalization was five days. Median stent patency was 137days (interquartile range [IQR] 80-214days). Re-intervention was required in four patients (9.3%) after mean 295.7days. Median overall survival was 153days (IQR 108-234days). Endoscopic bilateral SEMS in complex malignant hilar obstruction has good outcomes in the form of technical success, functional success and stent patency. Survival is dismal despite optimal biliary drainage.

Predictors of Acute and Late Toxicity in Patients Receiving Chemoradiation for Unresectable Pancreatic Cancer

Patients with pancreatic cancer undergoing chemoradiation therapy may experience acute and chronic side effects. We conducted an exploratory analysis of patients with locally advanced pancreatic cancer (LAPC) undergoing definitive chemoradiation to identify factors influencing the occurrence of gastrointestinal (GI) bleeding, short-term radiation side effects, patterns of failure, and survival. Under an institutional review board-approved protocol, we retrospectively studied patients with LAPC treated with chemoradiation. Statistical models were used to test associations between clinical characteristics and outcomes, including upper GI bleeding, radiation treatment breaks, and weight loss during therapy. Between 1999 and 2012, 211 patients were treated with radiation for pancreatic cancer. All patients received concurrent chemotherapy with either gemcitabine (174) or 5-fluorouracil (27), and 67 received intensity modulated radiation therapy (IMRT). Overall, 18 patients experienced an upper GI bleed related to treatment, with 70% of bleeds occurring in the stomach or duodenum, and among those patients, 11 (61%) patients had a pancreatic head tumor and 17 (94%) patients had a metallic biliary stent. IMRT was associated with decreased risk of postradiation nausea (odds ratio, 0.27 [0.11, 0.67], P=.006) compared with 3-dimensional conformal radiation. Regarding long-term toxicities, patients with a metallic biliary stent at the time of radiation therapy were at a significantly higher risk of developing upper GI bleeding (unadjusted hazard ratio [HR], 15.41 [2.02, 117.42], P=.008), even after controlling for radiation treatment modality and prescribed radiation dose (adjusted HR, 17.38 [2.26, 133.58], P=.006). Furthermore, biliary stent placement was associated with a higher risk of death (HR, 1.99 [1.41, 2.83], P < .001) after adjusting for demographic, treatment-related, and patient-related variables. Metallic biliary stents may be associated with an increased risk of upper GI bleeding and mortality. Furthermore, IMRT was associated with less nausea and short-term toxicity compared with 3-dimensional conformal therapy.

Novel anti-reflux biliary metal stent with a distal tapered end for distal malignant biliary obstruction: a feasibility study.

Background and study aims We developed a self-expandable metallic stent (SEMS) with a distal tapered end to reproduce the physiological bile flow with a pressure gradient due to the difference in the diameter. We aimed to evaluate the safety and efficacy of the newly developed distal tapered covered metal stent (TMS) for distal malignant biliary obstruction (DMBO). Patients and methods This single-center, prospective, single-arm study was conducted in patients with DMBO. The primary endpoint was time to recurrent biliary obstruction (TRBO), and the secondary endpoints were the survival time and incidence of adverse events (AEs). Results Thirty-five patients (15 men, 20 women; median age, 81 years [range: 53-92]) were enrolled between December 2017 and December 2019. The primary diseases were pancreatic head cancer in 25 cases, bile duct cancer in eight cases, and ampullary cancer in two cases. TMS was successfully placed in all cases. Acute cholecystitis occurred as an early AE (within 30 days) in two cases (5.7 %). The median TRBO was 503 days, median survival time was 239 days. RBO was observed in 10 cases (28.6 %), and the causes were distal migration in six cases, proximal migration in two cases, biliary sludge in one case, and tumor overgrowth in one case. Conclusions Endoscopic placement of the newly developed TMS in patients with DMBO is technically feasible and safe, and the TRBO was remarkably long. The anti-reflux mechanism based on the difference in diameter may be effective, and a randomized controlled trial with a conventional SEMS is required.