Risk Factors of Duodenobiliary Reflux-Related Dysfunction of Covered Biliary Metal Stents after Treatment of Duodenal Stricture in Patients with Malignant Biliary and Duodenal Obstruction.

Duodenal obstruction is often accompanied with unresectable malignant distal biliary obstruction in patients who have undergone biliary self-expandable metal stent (SEMS) placement. Duodenobiliary reflux (DBR) is a major cause of recurrent biliary obstruction (RBO) after covered biliary SEMS placement. We analyzed the risk factors for DBR-related SEMS dysfunction following treatment for malignant duodenal obstruction. Sixty-one patients with covered SEMS who underwent treatment for duodenal obstruction were included. We excluded patients with tumor-related stent dysfunction (n = 6) or metal stent migration (n = 1). Fifty-four patients who underwent covered biliary SEMS placement followed by duodenal metal stenting or surgical gastrojejunostomy were included. Eleven patients had DBR-related biliary SEMS dysfunction after treatment of duodenal obstruction. There was no difference between the duodenal metal stenting group and the surgical gastrojejunostomy group. Duodenal obstruction below the papilla of Vater and a score of ≤2 on the Gastric Outlet Obstruction Scoring System after treatment for duodenal obstruction were associated with DBR-related covered biliary SEMS dysfunction. Thus, creating a reliable route for ensuring good oral intake and avoiding DBR in patients with duodenal obstruction below the papilla of Vater are both important factors in preventing DBR-related covered biliary SEMS dysfunction.

The combination of endoluminal radiofrequency ablation and metal stent implantation for the treatment of malignant biliary stenosis - Randomized study.

PURPOSE: To analyse whether endobiliary radiofrequency ablation prior metal stent insertion in malignant biliary stenosis show improved survival or stent patency. METHODS: 76 patients with histologically proven malignant biliary stenosis have been enrolled in a prospective, randomized study. In control arm, 40 patients underwent self-expandable metal stent insertion. In experimental arm, the endoluminal ablation with a bipolar radiofrequency catheter was performed immediately before stent insertion. A subgroup analysis of cholangiocarcinoma was performed (22 vs 21 patients). The objective of the study was to determine the rate of complications, duration of the stent patency and the survival of patients (Kaplan-Meier analysis). RESULTS: No major complications related to the stent insertion and the endoluminal ablation were found. The mean primary stent patency was 5.2 (95% CI 0.7-12.8) vs 4.8 months (95% CI 0.8-18.2) months (p = 0.79) in control and experimental group, respectively, in the subgroup analysis with cholangiocarcinoma 4.5 (95% CI 0.8-10.3) and 9.6 (95% CI 5.2-11.2) months (p = 0.029). The median survival since the insertion of the stent was 6.8 (95 %CI 3.0-10.6) vs 5.2 (95 %CI 2.4-7.9) months (p = 0.495) and since the initial drainage 9.8 (95 %CI 6.9-12.7) vs 9.1 (95 %CI 5.4-12.7) months (p = 0.720) in the control and experimental arm. CONCLUSION: Endobiliary radiofrequency ablation prior metal stent insertion showed increased patency rate only in patients with cholangiocarcinoma, on the other hand, no improvement in survival was demonstrated in this randomized clinical study.

Extrabiliary applications of fully covered antimigration biliary metal stents.

BACKGROUND AND AIMS: Endoscopic stent placement in luminal GI strictures is not always feasible with traditional stents. For example, standard luminal stent delivery catheters may not successfully traverse severe strictures, and enteral stents may not be suitable for sites in the GI tract that pose significant adverse events if downstream migration were to occur. We demonstrate extrabiliary applications of specialized, fully covered antimigration biliary metal stents. METHODS: This is a retrospective series of 4 patients with different benign and malignant luminal GI strictures who underwent placement of fully covered antimigration biliary metal stents in different configurations as a bridge or destination therapy. RESULTS: Luminal obstruction resolved without adverse events in all cases. CONCLUSIONS: Although off label, extrabiliary use of these stents can successfully address scenarios of complex luminal pathology. To compensate for the small stent caliber, two stents may be placed side by side in a double-barrel configuration. Strict diet modifications are necessary when applying this therapeutic paradigm.

Lumen-apposing metal stents for malignant biliary obstruction: Is this the ultimate horizon of our experience?

In the last years, endoscopic ultrasonography (EUS) has evolved from a purely diagnostic technique to a more and more complex interventional procedure, with the possibility to perform several type of therapeutic interventions. Among these, EUS-guided biliary drainage (BD) is gaining popularity as a therapeutic approach after failed endoscopic retrograde cholangiopancreatography in distal malignant biliary obstruction (MBO), due to the avoidance of external drainage, a lower rate of adverse events and re-interventions, and lower costs compared to percutaneous trans-hepatic BD. Initially, devices created for luminal procedures (e.g., luminal biliary stents) have been adapted to the new trans-luminal EUS-guided interventions, with predictable shortcomings in technical success, outcome and adverse events. More recently, new metal stents specifically designed for transluminal drainage, namely lumen-apposing metal stents (LAMS), have been made available for EUS-guided procedures. An electrocautery enhanced delivery system (EC-LAMS), which allows direct access of the delivery system to the target lumen, has subsequently simplified the classic multi-step procedure of EUS-guided drainages. EUS-BD using LAMS and EC-LAMS has been demonstrated effective and safe, and currently seems one of the most performing techniques for EUS-BD. In this Review, we summarize the evolution of the EUS-BD in distal MBO, focusing on the novelty of LAMS and analyzing the unresolved questions about the possible role of EUS as the first therapeutic option to achieve BD in this setting of patients.

Partially covered metal stents have longer patency than uncovered and fully covered metal stents in the management of distal malignant biliary obstruction: a retrospective study.

BACKGROUND: Self-expandable metal stents (SEMSs) are widely used for malignant biliary obstructions. Nitinol-covered SEMSs have been developed to improve stent patency. Currently, SEMSs may be uncovered, partially covered, or fully covered; however, there is no consensus on the best stent type for the management of malignant distal biliary obstruction (MDBO). METHODS: Patients with unresectable MDBO receiving SEMS (Wallflex™) were retrospectively analyzed. Time to recurrent biliary obstruction (TRBO) and survival time were compared among the three types of SEMSs. Univariate and multivariate analyses were performed to identify risk factors for stent dysfunction. RESULTS: In total, 101 patients received SEMSs for unresectable MDBO (44 uncovered, 28 partially covered, and 29 fully covered SEMSs). Median survival time was 200, 168, and 276 days in the uncovered, partially covered, and fully covered SEMSs groups, respectively. There were no differences in survival among the three groups. Median TRBO was 199, 444, and 194 days in the uncovered, partially covered, and fully covered SEMSs groups, respectively. Partially covered SEMSs had longer TRBO than uncovered (p = 0.013) and fully covered (p = 0.010) SEMSs. Tumor ingrowth occurred only with uncovered SEMSs and stent migration occurred only with fully covered SEMSs. Multivariate analyses confirmed that partially covered SEMSs have lower risk of dysfunction. CONCLUSIONS: Partially covered SEMSs with a proximal uncovered flared end have longer patency than uncovered and fully covered SEMSs by preventing tumor ingrowth and stent migration.

[Cost-effectiveness trial of self-expandable metal stents and plastic biliary stents in malignant biliary obstruction]. / A fém- és muanyag stentek költséghatékonysága malignus epeúti szukületek esetében - összehasonlító vizsgálat.

INTRODUCTION: Self-expandable metal and plastic stents can be applied in the palliative endoscopic treatment of patients with unresectable malignant biliary obstruction. The use of metal stentsis recommended if the patient's life expectancy is more than four months. AIM: To compare the therapeutic efficacy and cost-effectiveness of metal and plastic stents in the treatment of malignant biliary obstruction. METHOD: The authors retrospectively enrolled patients who received metal (37 patients) or plastic stent (37 patients). The complication rate, stent patency and cumulative cost of treatment were assessed in the two groups. RESULTS: The complication rate of metal stents was lower (37.84% vs. 56.76%), but the stent patency was higher compared with plastic stents (19.11 vs. 8.29 weeks; p = 0.0041). In the plastic stent group the frequency of hospitalization of patients in context with stent complications (1.18 vs. 2.32; p = 0.05) and the necessity of reintervention for stent dysfunction (17 vs. 27; p = 0.033) were substantially higher. In this group multiple stent implantation raised the stent patency from 7.68 to 10.75 weeks. There was no difference in the total cost of treatment of malignant biliary obstruction between the two groups (p = 0.848). CONCLUSIONS: Considering the cost of treatment and the burden of patients the authors recommend self-expandable metal sten timplantation if the life expectancy of patients is more than two months. In short survival cases multiple plastic stent implantation is recommended.

Analysis of Endoscopic Radiofrequency Ablation of Biliary Malignant Strictures in Pancreatic Cancer Suggests Potential Survival Benefit.

BACKGROUND: Pancreatic carcinoma is often inoperable, carries a poor prognosis, and is commonly complicated by malignant biliary obstruction. Phase I/II studies have demonstrated good safety and early stent patency using endoscopic biliary radiofrequency ablation (RFA) as an adjunct to self-expanding metal stent (SEMS) insertion for biliary decompression. AIM: To analyze the clinical efficacy of endobiliary RFA. METHODS: Retrospective case-control analysis was carried out for 23 patients with surgically unresectable pancreatic carcinoma and malignant biliary obstruction undergoing endoscopic RFA and SEMS insertion and 46 controls (SEMS insertion alone) in a single tertiary care center. Controls were stringently matched for age, sex, metastases, ASA/comorbidities. Survival, morbidity, and stent patency rates were assessed. RESULTS: RFA and control groups were closely matched-ASA 2.35 ± 0.65 versus 2.54 ± 0.50, p = 0.086; metastases 9/23 (39.1%) versus 18/46 (39.1%), p = 0.800; chemotherapy 16/23 (69.6%) versus 24/46 (52.2%), p = 0.203. Median survival in RFA group was 226 days (IQR 140-526 days) versus 123.5 days (IQR 44-328 days) in controls (p = 0.010). RFA was independently predictive of survival at 90 days (OR 21.07, 95% CI 1.45-306.64, p = 0.026) and 180 days (OR 4.48, 95% CI 1.04-19.30, p = 0.044) in multivariate analysis. SEMS patency rates were equivalent in both groups. RFA was well tolerated with minimal side effects. CONCLUSIONS: Endoscopic RFA is a safe and efficacious adjunctive treatment in patients with advanced pancreatic malignancy and biliary obstruction and may confer early survival benefit. Randomized prospective clinical trials of this new modality are mandated.

Radiotherapy prolongs biliary metal stent patency in malignant pancreatobiliary obstructions.

BACKGROUND/AIMS: Biliary stenting is the most effective decompressive method for treating malignant biliary obstructive jaundice. Although the main cause of stent occlusion is tumor growth, few studies have investigated whether stent patency is affected by the combination of cancer-treatment modalities. The aim of this study was to evaluate the effects of local radiotherapy on metal-stent patency in patients with malignant biliary obstruction. METHODS: Patients who underwent self-expandable biliary metallic stenting for malignant biliary obstruction from 1999 to 2007 were included. Forty patients received chemotherapy and radiation therapy (radiation group, RG), and 31 patients received only chemotherapy (nonradiation group, NRG). RESULTS: The cumulative median stent patency was significantly longer in the RG than in the NRG (17.7 months; 95% confidence interval [CI], 1.8 to 33.6 months vs 8.7 months; 95% CI, 4.9 to 12.5 months; p=0.025). Stent occlusion caused by tumor growth or stent migration occurred in two (5%) and three (7.5%) cases in the RG and in six (19.3%) and two (6.5%) cases in the NRG, respectively. CONCLUSIONS: The patency of biliary metal stents in pancreatobiliary cancer patients who receive chemoradiation therapy is significantly longer than that in patients who do not receive radiotherapy, which suggests that local cancer control significantly affects stent patency.

Radiotherapy Prolongs Biliary Metal Stent Patency in Malignant Pancreatobiliary Obstructions

BACKGROUND/AIMS: Biliary stenting is the most effective decompressive method for treating malignant biliary obstructive jaundice. Although the main cause of stent occlusion is tumor growth, few studies have investigated whether stent patency is affected by the combination of cancer-treatment modalities. The aim of this study was to evaluate the effects of local radiotherapy on metal-stent patency in patients with malignant biliary obstruction. METHODS: Patients who underwent self-expandable biliary metallic stenting for malignant biliary obstruction from 1999 to 2007 were included. Forty patients received chemotherapy and radiation therapy (radiation group, RG), and 31 patients received only chemotherapy (nonradiation group, NRG). RESULTS: The cumulative median stent patency was significantly longer in the RG than in the NRG (17.7 months; 95% confidence interval [CI], 1.8 to 33.6 months vs 8.7 months; 95% CI, 4.9 to 12.5 months; p=0.025). Stent occlusion caused by tumor growth or stent migration occurred in two (5%) and three (7.5%) cases in the RG and in six (19.3%) and two (6.5%) cases in the NRG, respectively. CONCLUSIONS: The patency of biliary metal stents in pancreatobiliary cancer patients who receive chemoradiation therapy is significantly longer than that in patients who do not receive radiotherapy, which suggests that local cancer control significantly affects stent patency.

Late Migration of Covered Metal Stent to the Stomach Through a Spontaneous Choledochoduodenal Fistula in a Patient With Malignant Biliary Obstruction.

We report a case in which a spontaneous choledochoduodenal fistula occurred after biliary covered self-expanding metal stent (SEMS) placement and a late transfistula migration of the stent in a patient with malignant distal biliary obstruction. A partially covered WallFlex biliary stent (Boston Scientific) was appropriately implanted in the common bile duct. Subsequently the patient received chemotherapy with gemcitabine. After 7 months of the SEMS insertion, the patient presented with frequent vomiting. Abdominal computed tomography revealed the obstruction of the duodenal descending part and the migrated stent in the stomach. A choledochoduodenal fistula was observed endoscopically at the proximal point of the duodenal obstruction. These findings can cleanly account for the SEMS migration through the fistula. The mechanism of formation of the fistula is mostly associated with a mechanical contact between the bile duct wall and the SEMS edge, which is pushed up in the direction of the duodenum because of the enlargement of the primary tumor, finally penetrating through the duodenal wall. To our knowledge, this is an extreme unusual case, which has been unreported previously. Therefore, we emphasize the necessity of being alert to the potential for such complications in cases involving placement of SEMS for malignant biliary obstruction.