nitinol and Cholestasis

This article begins with an overview of the history and development of stents. The material properties unique to the Ultraflex esophageal stent and the Diamond biliary stent along with their clinical benefits are presented in detail. The author also provides detailed product information, recommendations, and contraindications for the use of both stents.

Topics: Alloys; Cholestasis; Coated Materials, Biocompatible; Esophageal Stenosis; Humans; Pliability; Prosthesis Design; Prosthesis Implantation; Stents

The Ultraflex Diamond stent presents three features that might be of interest when treating biliary strictures: ease of insertion, high flexibility, and presentation of relatively large meshes. Limited clinical studies have shown its efficacy in relieving duct obstruction (in contrast with some other stent models, correct positioning of the Ultraflex Diamond stent provides adequate biliary drainage in almost all cases), and satisfactory long-term patency rates. The main improvement awaited is an efficient means to prevent late stent obstruction. The addition of coverage to this stent is feasible and could be the first step toward this goal.

Topics: Alloys; Bile Duct Neoplasms; Biocompatible Materials; Cholestasis; Endoscopy, Digestive System; Humans; Palliative Care; Pancreatic Neoplasms; Pliability; Prosthesis Implantation; Radiography; Stents; Treatment Outcome

To prove that covered stents are more efficacious than uncovered stents regarding patency, safety, enabling of chemotherapy, and survival in percutaneous palliation of malignant infrahilar biliary obstruction.. After failed endoscopic treatment, 154 patients with obstructive jaundice caused by unresectable infrahilar malignancy were randomly allocated to receive an expanded polytetrafluoroethylene and fluorinated ethylene propylene-covered or an uncovered nitinol stent. Occlusion rate, patency, and survival were assessed. Safety and clinical success in terms of chemotherapy were compared.. Three patients were excluded post hoc. Fifteen patients died within 7 d and were excluded from patency analysis. Occlusion rates were 32% (21 of 66) for covered and 29% (20 of 70) for uncovered stents (P = .7). Estimated median patency durations were 308 d (95% confidence interval [CI], 178-438 d) for covered and 442 d (95% CI, 172-712 d) for uncovered stents (P = .1). Serious adverse events (P = 1.0) and 30-day mortality (P = .5) were equivalent between groups. At hospital discharge, median bilirubin reduction of 8 mg/dL was found in both groups (P < .001). In the covered stent group, 35 patients (48%) received palliative chemotherapy, vs 29 (37%) in the uncovered stent group (P = .2). Estimated median survival times were 96 days (95% CI, 68-124 d) with covered stents and 75 days (95% CI, 42-108 d) with uncovered stents (P = .6).. In malignant infrahilar biliary obstruction not amenable to endoscopy, no improvement in patency or survival with percutaneously placed covered stents could be confirmed. Covered and uncovered stent types exhibit similar safety profiles and clinical success rates.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Belgium; Cholestasis; Coated Materials, Biocompatible; Digestive System Neoplasms; Drainage; Female; Humans; Male; Middle Aged; Palliative Care; Polytetrafluoroethylene; Prospective Studies; Prosthesis Design; Risk Factors; Stents; Time Factors; Treatment Outcome; Young Adult

To prospectively evaluate safety and efficacy of biliary stent placement with iodine-125 (. From July 2011 to June 2014, 55 patients were enrolled (group A, 11 men and 17 women, mean age 70.93 y ± 8.58; group B, 14 men and 13 women, mean age 70.26 y ± 9.71). All patients were randomly assigned to placement of a biliary stent with. Stents were successfully placed in all 55 patients. MOJ was relieved in all patients, and there were no significant differences in complications related to stent insertion between the 2 groups. Mean and median stent patency were 191 days ± 19.8 (95% confidence interval [CI], 152-230 d) and 179 days ± 191.4 (95% CI, 87-267 d) in group A and 88.3 days ± 16.3 (95% CI, 61-114 d) and 77 days ± 88.2 (95% CI, 65-86 d) in group B (P < .001, log-rank test). Mean and median survival time were 222.6 days ± 21.0 (95% CI, 181-263 d) and 241 days ± 18.2 (95% CI, 179-270 d) in group A and 139.1 days ± 14.5 (95% CI, 110-167 d) and 142 days ± 16.3 (95% CI, 83-177 d) in group B (P < .001, log-rank test).

Topics: Aged; Aged, 80 and over; Alloys; Brachytherapy; China; Cholestasis; Digestive System Neoplasms; Female; Humans; Iodine Radioisotopes; Jaundice, Obstructive; Kaplan-Meier Estimate; Male; Middle Aged; Positron Emission Tomography Computed Tomography; Prospective Studies; Radiography, Interventional; Risk Factors; Self Expandable Metallic Stents; Time Factors; Treatment Outcome

Covered nitinol alloy self-expandable metal stents (SEMSs) have been developed to overcome the shortcomings of steel SEMS in patients with malignant biliary obstruction. In a randomized, multicenter trial, we compared stent patency, patient survival, and adverse events in patients with partly covered stents made from steel or nitinol.. A total of 400 patients with unresectable distal malignant biliary obstruction were randomized at endoscopic retrograde cholangiopancreatography (ERCP) to insertion of a steel or nitinol partially covered SEMS, with 200 patients in each group. The primary outcome was confirmed stent failure during 300 days of follow-up. . At 300 days, the proportion of patients with patent stents was 77 % in the steel group, compared with 89 % in the nitinol group (P = 0.01). Confirmed stent failure occurred more often in the steel SEMS group compared with the nitinol SEMS group, in 30 versus 14 patients (P = 0.02). Stent migration occurred in 13 patients in the steel group and in 3 patients in the nitinol group (P = 0.01). Median patient survival (secondary outcome) was 137 days and 120 days in the steel SEMS and nitinol SEMS groups, respectively (P = 0.59).. The nitinol SEMS showed longer patency time, and the nitinol group had fewer patients with stent failure, compared with the steel SEMS group. We could not detect any differences between the two groups regarding survival time, and regarding adverse event rate.Clinical trial registration : NCT 00980889.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Cholangiopancreatography, Endoscopic Retrograde; Cholestasis; Female; Humans; Male; Middle Aged; Palliative Care; Pancreatic Neoplasms; Prosthesis Failure; Steel; Stents; Survival Rate

Stent migration occurs frequently, but the prevention of complications resulting from covered self-expandable metal stents (C-SEMSs) remains unresolved. We prospectively assessed a newly developed C-SEMS, a modified covered Zeo stent (m-CZS), in terms of its antimigration effect.. Between February 2010 and January 2011, an m-CZS was inserted into 42 patients (31 initial drainage cases and 11 reintervention cases) at a tertiary referral center and three affiliated hospitals. The laser-cut stent was flared for 1.5 cm at both ends, with a 1 cm raised bank located 1 cm in from each flared end. The main outcome of this study was the rate of stent migration, and secondary outcomes were the rate of recurrent biliary obstruction (RBO), the time to RBO, the frequencies of complications, and overall survival.. Of the 31 patients with initial drainage, stent migration occurred in four (12.9%, 95% confidence interval, 5.1% to 29.0%), with a mean time of 131 days. RBO occurred in 18 (58%), with a median time to RBO of 107 days. Following previous C-SEMS migration, seven of 10 patients (70%) did not experience m-CZS migration until death.. m-CZSs with antimigration properties effectively, although not completely, prevented stent migration after stent insertion.

Topics: Aged; Aged, 80 and over; Alloys; Carcinoma; Cholestasis; Digestive System Neoplasms; Drainage; Equipment Design; Feasibility Studies; Female; Humans; Kaplan-Meier Estimate; Lymphatic Metastasis; Male; Middle Aged; Prosthesis Failure; Recurrence; Reoperation; Stents; Time Factors

Biliary partially covered self-expandable metal stents (PC-SEMS) offer prolonged relief of symptoms of biliary obstruction but may induce complications including pancreatitis, cholecystitis and migration.. To assess efficacy and safety of the ComVi partially covered self-expandable metal stents as primary palliative treatment of distal malignant biliary obstruction.. Seventy patients (mean age 69.2 years) with distal malignant biliary strictures were prospectively included and underwent endoscopic retrograde cholangio-pancreatography and partially covered self-expandable metal stents placement. Follow-up was done for 12 months. self-expandable metal stents patency, survival and complication-rate after partially covered self-expandable metal stents placement were evaluated.. Overall median survival time was 190 days (30-856). Forty-four patients (62.8%) died after median 175.5 days (30-614) without signs of stent dysfunction; 37 patients (52.8%) were alive after 6 months without signs of self-expandable metal stents occlusion. Survival rapidly dropped between 8 and 12 months after treatment. Survival was not influenced by sex (P = 0.1) or type of neoplasia (P = 0.178). Median survival was longer (254 days [44-836]) in patients who underwent chemotherapy (P < 0.0001). Partially covered self-expandable metal stents occlusion had 24 (35.7%) patients 154 days (35-485) after treatment. Median survival after re-treatment was 66 days (13-597). Cholecystitis occurred in one patient (1.7%).. The ComVi partially covered self-expandable metal stents is effective for palliation of biliary obstruction secondary to distal malignant biliary strictures. Self-expandable metal stents patency during follow-up is satisfactory without significant complications.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Bilirubin; Cholangiopancreatography, Endoscopic Retrograde; Cholestasis; Female; Follow-Up Studies; Humans; Logistic Models; Male; Middle Aged; Multivariate Analysis; Neoplasms; Palliative Care; Proportional Hazards Models; Stents

Covered self-expandable metal stents (CSEMSs) were developed to prevent tumor ingrowth, but stent migration is one of the problems with CSEMSs.. To evaluate a new, commercially available CSEMS with flared ends and low axial force compared with a commercially available CSEMS without the anti-migration system and high axial force.. Multicenter, prospective study with a historical cohort.. Twenty Japanese referral centers.. This study involved patients with unresectable distal malignant biliary obstruction.. Placement of a new, commercially available, partially covered SEMS.. Recurrent biliary obstruction rate, time to recurrent biliary obstruction, stent-related complications, survival.. Between April 2009 and March 2010, 141 patients underwent partially covered nitinol stent placement, and between May 2001 and January 2007, 138 patients underwent placement of partially covered stainless stents as a historical control. The silicone cover of the partially covered nitinol stents prevented tumor ingrowth. There were no significant differences in survival (229 vs 219 days; P = .250) or the rate of recurrent biliary obstruction (33% vs 38%; P = .385) between partially covered nitinol stents and partially covered stainless stents. Stent migration was less frequent (8% vs 17%; P = .019), and time to recurrent biliary obstruction was significantly longer (373 vs 285 days; P = .007) with partially covered nitinol stents. Stent removal was successful in 26 of 27 patients (96%).. Nonrandomized, controlled trial.. Partially covered nitinol stents with an anti-migration system and less axial force demonstrated longer time to recurrent biliary obstruction with no tumor ingrowth and less stent migration.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Bile Duct Neoplasms; Cholestasis; Device Removal; Female; Gallbladder Neoplasms; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Pancreatic Neoplasms; Proportional Hazards Models; Prosthesis Design; Prosthesis Failure; Recurrence; Silicones; Stainless Steel; Stents; Time Factors

Covered biliary metal stents have been developed to prevent tumor ingrowth. Previous comparative studies are limited and often include few patients.. To compare differences in stent patency, patient survival, and complication rates between covered and uncovered nitinol stents in patients with malignant biliary obstruction.. Randomized, multicenter trial conducted between January 2006 and October 2008.. Ten sites serving a total catchment area of approximately 2.8 million inhabitants.. A total of 400 patients with unresectable distal malignant biliary obstruction.. ERCP with insertion of covered or uncovered metal stent. Follow-up conducted monthly for symptoms indicating stent obstruction.. Time to stent failure, survival time, and complication rate.. The patient survival times were 116 days (interquartile range 242 days) and 174 days (interquartile range 284 days) in the covered and uncovered stent groups, respectively (P = .320). The first quartile stent patency time was 154 days in the covered stent group and 199 days in the uncovered stent group (P = .326). There was no difference in the incidence of pancreatitis or cholecystitis between the 2 groups. Stent migration occurred in 6 patients (3%) in the covered group and in no patients in the uncovered group (P = .030).. Randomization was not blinded.. There were no significant differences in stent patency time, patient survival time, or complication rates between covered and uncovered nitinol metal stents in the palliative treatment of malignant distal biliary obstruction. However, covered stents migrated significantly more often compared with uncovered stents, and tumor ingrowth was more frequent in uncovered stents.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Biliary Tract Neoplasms; Cholangiopancreatography, Endoscopic Retrograde; Cholestasis; Cohort Studies; Disease-Free Survival; Equipment Design; Female; Humans; Male; Middle Aged; Palliative Care; Recurrence; Stents; Treatment Outcome

The Wallstent has remained the industry standard for biliary self-expanding metal stents (SEMSs). Recently, stents of differing designs, compositions, and diameters have been developed.. To compare the new nitinol 6-mm and 10-mm Zilver stents with the 10-mm stainless steel Wallstent and determine the mechanism of obstruction.. Randomized, prospective, controlled study.. Nine centers experienced in SEMS placement during ERCP.. A total of 241 patients presenting between September 2003 and December 2005 with unresectable malignant biliary strictures at least 2 cm distal to the bifurcation.. Stent occlusions requiring reintervention and death.. At interim analysis, a significant increase in occlusions was noted in the 6-mm Zilver group at the P = .04 level, resulting in arm closure but continued follow-up. Final study arms were 64, 88, and 89 patients receiving a 6-mm Zilver, 10-mm Zilver, and 10-mm Wallstent, respectively. Stent occlusions occurred in 25 (39.1%) of the patients in the 6-mm Zilver arm, 21 (23.9%) of the patients in the 10-mm Zilver arm, and 19 (21.4%) of the patients in the 10-mm Wallstent arm (P = .02). The mean number of days of stent patency were 142.9, 185.8, and 186.7, respectively (P = .057). No differences were noted in secondary endpoints, and the study was ended at the 95% censored study endpoints. Biopsy specimens of ingrowth occlusive tissue revealed that 56% were caused by benign epithelial hyperplasia.. SEMS occlusions were much more frequent with a 6-mm diameter SEMS and equivalent in the two 10-mm arms despite major differences in stent design, material, and expansion, suggesting that diameter is the critical feature. Malignant tumor ingrowth produced only a minority of the documented occlusions.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Bile Duct Neoplasms; Catheterization; Cholangiopancreatography, Endoscopic Retrograde; Cholestasis; Female; Humans; International Cooperation; Kaplan-Meier Estimate; Male; Middle Aged; Neoplasm Staging; Palliative Care; Patient Selection; Probability; Prognosis; Prospective Studies; Prosthesis Design; Prosthesis Failure; Quality of Life; Risk Assessment; Stainless Steel; Stents; Survival Analysis; Terminally Ill; Treatment Outcome

Topics: Aged; Alloys; Anastomosis, Surgical; Cholestasis; Endosonography; Gastroscopy; Hepatic Duct, Common; Humans; Male; Retreatment; Stents; Stomach; Ultrasonography, Interventional

Topics: Alloys; Cholestasis; Colonic Diseases; Constriction, Pathologic; Duodenal Obstruction; Equipment Design; Esophageal Stenosis; Foreign-Body Migration; Humans; Intestinal Atresia; Postoperative Complications; Stents

The usefulness of bilateral stent placement for malignant hilar obstruction is still under debate. Nevertheless, many endoscopists advocate the placement of an endoscopic bilateral metal stent using various new devices and techniques.. We compared the technical and clinical efficacy, and the short-term and long-term complications of the 'stent-in-stent' method using a Y-stent for malignant hilar obstruction between the early and the late period of this study.. Ninety-seven patients treated with Y-stent implantation for malignant hilar obstruction were enrolled retrospectively. In 31 patients treated during the early period, bilateral Y-configured metal stents were placed for malignant hilar obstruction using the older designed Y-stent and a closed-cell second stent. The newly designed Y-stent and a slimmer open-cell second stent were introduced in 66 patients treated during the late period. New techniques learned through experience were gradually applied throughout the entire study period.. The rate of successful placement of bilateral stents was significantly higher in patients treated during the late period than those treated during the early period (58.1 vs. 87%; P=0.001). The functional success rate was 97.3%, with no difference between the early and the late periods. Cholangitis occurred as an early complication more frequently during the early period than during the late period (16.1 vs. 1.5%; P=0.012). Cholecystitis as a late complication occurred in 21 of 76 patients (27.6%). The incidence of late complications was similar between the early and the late periods.. With the development of new devices and increased technical experience, there were better outcomes during the late period compared with the early period. Endoscopic bilateral metal stenting using a Y-stent is an attractive option for the palliative treatment of malignant hilar obstruction.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Chi-Square Distribution; Cholangiopancreatography, Endoscopic Retrograde; Cholangitis; Cholecystitis; Cholestasis; Digestive System Neoplasms; Drainage; Female; Humans; Incidence; Kaplan-Meier Estimate; Male; Middle Aged; Palliative Care; Prosthesis Design; Republic of Korea; Retrospective Studies; Sphincterotomy, Endoscopic; Stents; Time Factors; Treatment Outcome

Various types of self-expandable metal stents have been introduced for the palliation of malignant biliary obstruction.. To compare the outcomes of WallFlex™ and Wallstent™ uncovered biliary self-expandable metal stents (SEMSs) for the palliation of patients with malignant biliary obstruction.. Between October 2008 and December 2009, all SEMSs placed for malignant biliary obstruction were WallFlex™: all patients palliated were included in the study. Before October 2008, all the SEMSs placed for malignant biliary obstruction were Wallstent™, and the patients palliated from July 2007 to September 2008 were the comparative group.. A total of 58 WallFlex™ and 54 Wallstent™ SEMSs were placed, and efficacious biliary decompression was achieved in all patients. Early complications occurred in 5 patients in the WallFlex™ group and in 3 in the Wallstent™ group (p=ns). Late complications occurred in 6 patients in the WallFlex™ group and in 16 in the Wallstent™ group (p<0.01). The overall patency of the self-expandable metal stent in the WallFlex™ and the Wallstent™ groups was similar (227 days vs. 215 days, p=ns). Mean patient survival was 242 days in the WallFlex™ group and 257 days in the Wallstent™ group (p=ns).. We found no difference in terms of overall patency between the two types of SEMSs, but there was an increased rate of late adverse events in the Wallstent™ group.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Biopsy, Fine-Needle; Cholangiopancreatography, Endoscopic Retrograde; Cholestasis; Endosonography; Female; Follow-Up Studies; Humans; Male; Middle Aged; Palliative Care; Pancreatic Neoplasms; Prosthesis Design; Retrospective Studies; Stainless Steel; Stents; Tomography, X-Ray Computed; Treatment Outcome

Topics: Alloys; Bile Duct Neoplasms; Cholestasis; Endoscopy; Humans; Palliative Care; Stents

Curative resection of pancreatic and biliary malignancies is rare. Most tumors are inoperable at presentation, and palliation of jaundice often is the goal. Biliary decompression can be achieved by surgical diversion or endoscopic biliary stents. This study aimed to compare clinical outcomes between surgical bypass and endoscopic uncovered nitinol stents in the palliation of patients with malignant distal common bile duct obstruction.. A multicenter, retrospective, cohort study investigated 86 patients with inoperable malignant distal common bile duct strictures at tertiary referral centers in Medellín, Colombia. These patients had undergone surgery (group 1) or placement of an uncovered 30-Fr self-expandable nitinol stent produced locally in Medellín, Colombia (group 2). The main outcome measurements included cumulative biliary patency, hospital stay, and patient survival.. The study enrolled 86 patients (mean age, 66 years; range, 43-78 years) including 40 patients in group 1 and 46 patients in group 2. Both groups were similar in terms of age, gender, liver metastasis, and diagnosis. Technical success was achieved for 38 patients in group 1 (95%) and 43 patients in group 2 (93%). Functional biliary decompression was obtained in for 35 of the surgical patients (88%) and 42 of the stented patients (91%). Group 2 had lower rates for procedure-related mortality (2 vs. 7.5%; p = 0.01), a lower frequency of early complications (8.7 vs. 45%; p = 0.02), and a shorter hospital stay (median, 6 vs. 12 days; p = 0.01). Recurrent jaundice occurred for three patients in group 1 (7.5%) and eight patients in group 2 (17.3%) (p = 0.198). Late gastric outlet obstruction occurred for 12.5% of the patients in group 1 and 13% of the patients in group 2 (p = 0.73). Despite the early benefits of stenting, no significant difference in the median overall survival between the two groups was found (group 1, 163 days; group 2, 178 days; p = 0.11). The limitations of this study included the small number of patients and the retrospective design.. Endoscopic stenting and surgery are effective palliation. The former is associated with fewer early complications and the latter with fewer late complications. Patients who do not qualify for curative resection may be better managed by stent placement. Surgery should be reserved for patients more likely to survive longer.

Topics: Adult; Aged; Alloys; Bile Duct Neoplasms; Chi-Square Distribution; Cholestasis; Decompression, Surgical; Digestive System Surgical Procedures; Drainage; Female; Humans; Male; Middle Aged; Palliative Care; Retrospective Studies; Statistics, Nonparametric; Stents; Treatment Outcome

Topics: Alloys; Biliary Tract Neoplasms; Cholangiopancreatography, Endoscopic Retrograde; Cholestasis; Cohort Studies; Equipment Design; Humans; Palliative Care; Stents

Self-expanding metallic stents are widely used for relieving biliary duct obstruction in patients with unresectable periampullary malignancies. However, only a few studies have assessed the occurrence of fractures in these stents.. To determine the prevalence and significance of stent fracture after placement of self-expanding metallic stents for periampullary malignant biliary obstruction.. Over a 5-year period, 48 patients underwent placement of self-expanding metallic stents for periampullary malignant biliary obstructions. Stents were introduced 2-6 weeks after a percutaneous transhepatic biliary decompression. The medical records and relevant images were reviewed for stent patency, stent fracture, type of stent, and stent-related complications.. Stent fracture was detected in four of the 48 patients (8%): in one patient at 1 month and in three patients between 10 and 21 months after stenting. All four fractures involved one type of nitinol stent used in 38 patients. In one of the patients, fracture was complicated by life-threatening gastrointestinal bleeding. The mean survival time for all patients was 251 days (standard deviation [SD]+/-275 days) and the mean overall patency time for all stents was 187 days (SD+/-205 days).. Stent fracture occurs after placement of self-expanding nitinol stents for periampullary malignant biliary obstruction. The low reported incidence of this complication may be due to a lack of awareness of and difficulty in detecting stent fracture. Fracture should be considered as a possible contributing factor in recurrent biliary obstruction after self-expanding metallic stent insertion.

Topics: Aged; Aged, 80 and over; Alloys; Bile Duct Neoplasms; Cholangiography; Cholestasis; Fatal Outcome; Female; Humans; Male; Middle Aged; Pancreatic Neoplasms; Prosthesis Failure; Stents

Topics: Alloys; Biliary Tract Neoplasms; Catheterization; Cholestasis; Female; Follow-Up Studies; Humans; Male; Palliative Care; Patient Selection; Prosthesis Design; Prosthesis Failure; Stainless Steel; Stents; Survival Analysis; Terminally Ill; Treatment Outcome

Malignant biliary obstruction may be caused by cholangiocarcinoma and other nonbiliary carcinomas. At the time of diagnosis, 90% of patients with malignant obstructive jaundice may benefit from palliative treatment only. The objective of palliation is to relieve jaundice-related symptoms, prevent cholangitis, prolong survival, and improve quality of life. Percutaneous transhepatic biliary stenting is a well-established procedure used in patients with malignant obstruction of intra- and extrahepatic bile ducts. Twelve patients (9 women, 3 men; mean age, 68 years; range, 44-88 years) with inoperable malignant biliary obstruction were selected for percutaneous transhepatic biliary stenting with metallic stents in the period from January to December 2007. Technical and clinical success rate in this patient series was 83% and 80%, respectively. Minor and major complications occurred in 17% and 8% of cases, respectively, which is in the range reported by the others. This is our first experience of percutaneous transhepatic biliary stenting at the Hospital of Kaunas University of Medicine and, to our knowledge, the first reported patient series in Lithuania. These first results encourage expanding effective palliation by the employment of the percutaneous transhepatic biliary stenting in patients with nonresectable malignant biliary obstruction or in case of a recurrent disease after curative surgery. The cost effectiveness of percutaneous transhepatic biliary stenting against percutaneous transhepatic biliary drainage has yet to be evaluated in a prospective manner. However, immediate clinical benefits and positive short-term outcomes are unequivocal.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Bile Duct Neoplasms; Bile Ducts, Intrahepatic; Cholangiocarcinoma; Cholestasis; Drainage; Endoscopy; Female; Follow-Up Studies; Gallbladder Neoplasms; Humans; Jaundice, Obstructive; Male; Middle Aged; Palliative Care; Pancreatic Neoplasms; Patient Selection; Postoperative Complications; Quality of Life; Radiography; Stainless Steel; Stents; Time Factors; Treatment Outcome

To evaluate the efficacy and safety of an expanded polytetrafluoroethylene-fluorinated ethylene-propylene (ePTFE/FEP)-covered metallic stent in the management of malignant biliary obstruction. Eighty consecutive patients with malignant common bile duct strictures were treated by placement of 83 covered metallic stents. The stent-graft consists of an inner ePTFE/FEP lining and an outer supporting structure of nitinol wire. Clinical evaluation, assessment of serum bilirubin and liver enzyme levels were analyzed before biliary drainage, before stent-graft placement and during the follow-up period at 1, 3, 6, 9 and 12 months. Technical success was obtained in all cases. After a mean follow-up of 6.9+/-4.63 months, the 30-day mortality rate was 14.2%. Survival rates were 40% and 20.2% at 6 and 12 months, respectively. Stent-graft patency rates were 95.5%, 92.6% and 85.7% at 3, 6 and 12 months, respectively. Complications occurred in five patients (6.4%); among these, acute cholecystitis was observed in three patients (3.8%). A stent-graft occlusion rate of 9% was observed. The percentage of patients undergoing lifetime palliation (91%) and the midterm patency rate suggest that placement of this ePTFE/FEP-covered stent-graft is safe and highly effective in achieving biliary drainage in patients with malignant strictures of the common bile duct.

Topics: Aged; Aged, 80 and over; Alloys; Antibiotic Prophylaxis; Cholangiography; Cholestasis; Coated Materials, Biocompatible; Common Bile Duct Neoplasms; Constriction, Pathologic; Female; Humans; Liver Function Tests; Male; Middle Aged; Palliative Care; Pancreatic Neoplasms; Polytetrafluoroethylene; Postoperative Complications; Prosthesis Design; Stents; Survival Rate

For the treatment of unresectable biliary tract carcinoma with hilar biliary stricture, antitumor therapy and biliary stenting should be addressed in terms of prolonged survival with a good quality of life. However, the endoscopic management of malignant hilar biliary strictures is difficult even for an expert endoscopist. We evaluated the efficacy and safety of the endoscopic deployment of multiple JOSTENT SelfX units in patients with hilar biliary strictures treated with or without chemotherapy.. Between November 2003 and December 2006, endoscopic deployment of multiple JOSTENT SelfX units in hilar biliary strictures by using a partial stent-in-stent procedure was performed on 41 consecutive patients with primary cholangiocarcinoma (n = 34) and gallbladder carcinoma (n = 7) at a gastroenterologic center of Okayama University Hospital. Thirty-three patients were treated with gemcitabine (n = 25) or S-1 (n = 8).. Metallic stent deployment was successfully accomplished in all cases via only endoscopic procedures. During the follow-up period (mean, 210 days), mean patency time was 150 days, and metallic stent obstruction occurred in 15 cases (37%). Although a repeat intervention was required in all metallic stent obstructed cases, the deployment of the second metallic or plastic stent was completed successfully. The remaining 26 cases (63%) required no interventions. The median overall survival period was only 235 days. However, that of the patients receiving chemotherapy was 392 days.. Endoscopic partial stent-in-stent deployment with multiple JOSTENT SelfX prostheses is effective and safe for the treatment of malignant hilar biliary stricture even in patients receiving chemotherapy.

Topics: Aged; Aged, 80 and over; Alloys; Antineoplastic Agents; Bile Duct Neoplasms; Cholangiocarcinoma; Cholestasis; Endoscopy, Digestive System; Feasibility Studies; Female; Gallbladder Neoplasms; Humans; Male; Middle Aged; Prosthesis Implantation; Reoperation; Retrospective Studies; Stents; Treatment Outcome

Topics: Alloys; Cholestasis; Constriction, Pathologic; Female; Humans; Hypersensitivity, Immediate; Middle Aged; Nickel; Stents

Although endoscopic stent placement is now generally accepted as a palliative method of treatment in unresectable hilar cholangiocarcinoma, exclusively endoscopic placement of bilateral metal stents has been considered very difficult and complex.. To evaluate the technical and clinical efficacy of endoscopic placement of dual, newly designed stents in a Y configuration.. Prospective, uncontrolled, single center.. Tertiary referral university hospital.. Ten patients with unresectable hilar cholangiocarcinoma of Bismuth type II or higher.. For bilateral metal stent placement, a biliary Y stent with central wide-open mesh was used exclusively at first. A second stent was placed into the contralateral hepatic duct through the central open mesh of the Y stent.. Technical success, functional success, early complications, and short-term clinical outcome.. Technical success was achieved in 8 of 10 patients (80%). Among 8 patients in whom bilateral stents were successfully placed by endoscopy, functional success was 100%, the early complication rate was 0%, and the stent occlusion rate was 25%. The median stent patency period was 217 days.. Small number of patients, uncontrolled study, short-term follow-up period.. We described a technique for endoscopic bilateral metal stent placement by using the newly designed Y stent for advanced hilar cholangiocarcinoma that resulted in a high success rate of 80%.

Topics: Aged; Alloys; Bile Duct Neoplasms; Bile Ducts, Intrahepatic; Cholangiocarcinoma; Cholestasis; Drainage; Endoscopy, Digestive System; Female; Hepatic Duct, Common; Humans; Male; Middle Aged; Palliative Care; Stents

To evaluate the treatment of malignant biliary stenoses and occlusions using a new stent.. In a prospective study, 25 patients with malignant obstructive jaundice were treated with SMART(R) stents. The handling and the quality of stent expansion were documented. Stent function was assessed 2 - 4 days after intervention by cholangiography and laboratory tests. A follow-up was performed three months, after stent placement.. All lesions were treated successfully, with a total of 35 stents implanted. In 14 patients a further balloon dilatation was performed after stent placement (8 - 10 mm diameter/ 40 - 80 mm length). The mean serum bilirubin level decreased significantly from 11.6 mg/dl to 4.6 mg/dl after intervention (p < 0.05). The follow-up showed a mean serum bilirubin level at 4.0 mg/dl. In 4 cases (16 %) a further intervention (PTCD or stent) was performed. Six patients died due to tumor progression. The stents proved to be patent in 79 % (n = 15) of patients alive at the time of follow-up.. Placement of the SMART stent for the therapy of malignant biliary lesions yields good technical and clinical results.

Topics: Aged; Aged, 80 and over; Alloys; Bilirubin; Breast Neoplasms; Carcinoma, Hepatocellular; Cholestasis; Colonic Neoplasms; Drainage; Female; Follow-Up Studies; Humans; Klatskin Tumor; Liver Neoplasms; Male; Middle Aged; Pancreatic Neoplasms; Prospective Studies; Radiography; Reoperation; Stents; Stomach Neoplasms; Time Factors

One of the major disadvantages of nitinol endocoil stents is said to be incomplete deployment leading to twisting and stent dysfunction. We report a patient with irresectable pancreatic head cancer where severe twisting of the nitinol stent occurred which resolved on the day after stent insertion; the stent took its normal shape ten days later, whereafter the patient lived without stent-related problems for one year until his death. This shows that prospective management rather than immediate stent extraction may be warranted in such cases of stent dysfunction.

Topics: Aged; Alloys; Bile Ducts; Cholestasis; Equipment Failure; Humans; Male; Palliative Care; Pancreatic Neoplasms; Stents

To evaluate the clinical usefulness of a new nitinol biliary stent (Memotherm) in patients with malignant biliary obstruction. 32 self expanding nitinol stents were applied in 17 patients. The following parameters were investigated: Difficulty of placement, lateral stability and patency over an observation time between 3 weeks and 11 months.. In 29/32 stent application could be performed with high precision. In 3/32 we observed a displacement about 1 cm--according to the optimal stent position. Stent shortening was about 5 mm in 31/32 stents, secondary shortening only occurred in one patient with primarily distracted stent design. Lateral stability was sufficient in 21/25 stenoses with the consequence that dilatation was only performed in 4 cases. Average stent patency was 4.8 months, the average survival 5.1 months. Because of his special design, this stent may not be used for a stenosis with angulation higher than 90 degrees.. Basing on a small calibre introducing system, easy placement, predictable minimal shortening and good lateral stability, the Memotherm seems an interesting alternative to other metal stents.

Topics: Alloys; Bile Duct Neoplasms; Cholestasis; Drainage; Evaluation Studies as Topic; Female; Humans; Male; Radiography; Stents