nitinol and Pancreatic-Neoplasms

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

The use of 19-gauge (G) stainless steel needles for endoscopic ultrasound-guided fine-needle biopsy of a pancreatic mass often results in technical difficulties due to an inability to advance the relatively rigid needle out of the endoscope. More flexible nitinol-based needles might decrease such technical difficulties and thus increase diagnostic accuracy.. In this prospective multicenter randomized single-blinded study we compared the diagnostic value of those two needle types in patients with a solid pancreatic lesion.. Patients with a solid pancreatic mass were diagnosed with endoscopic ultrasound-guided fine-needle biopsy using one puncture with each needle in a randomized fashion. The primary endpoint was the diagnostic accuracy of each needle. Secondary endpoints included time for puncture, amount of tumour tissue obtained, and technical failure. Histological specimens were centrally reviewed by a pathologist blinded to the final needle type and final diagnosis (ClinicalTrials.gov Identifier: NCT02909530).. Out of 46 prospectively recruited patients, central pathological examination was available for 41. Diagnostic accuracy for the two needles combined was 87.8%. Diagnostic accuracy was 66% and 68% using the stainless steel- and nitinol-based needle respectively. Time spent for puncturing was 137 ± 61 s (mean ± standard deviation) for the stainless steel and 111 ± 53 s for the nitinol-based needle (. Usage of a nitinol-based 19-G needle failed to present a significant superior accuracy compared with a stainless steel needle in endoscopic ultrasound-guided fine-needle biopsy of solid pancreatic lesions.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Endoscopic Ultrasound-Guided Fine Needle Aspiration; Female; Follow-Up Studies; Humans; Male; Middle Aged; Needles; Pancreas; Pancreatic Neoplasms; Prospective Studies; Stainless Steel

The aim of this prospective multicenter study was to compare a flexible 19 G needle with nitinol shaft (19 G Flex) with a standard 22 G needle for transduodenal endoscopic ultrasound (EUS)-guided sampling of pancreatic head tumors.. Patients with pancreatic head tumors requiring tissue diagnosis were randomized into two arms: puncture with either a 19 G Flex needle or a 22 G needle. The primary end point was diagnostic accuracy for malignancy. The secondary end points were ergonomic scores, sample cytohistological quality, and complications. A 6-month follow-up was performed.. 125 patients were randomized and 122 were analyzed: 59 patients in the 19 G Flex arm and 63 patients in the 22 G arm. The final diagnosis was malignancy in 111 patients and benign condition in 11. In intention-to-treat analysis, the diagnostic accuracy for malignancy of the 19 G Flex and 22 G needles was 69.5 % (95 % confidence interval [CI] 56.1 % - 80.8 %) vs. 87.3 % (95 %CI 76.5 % - 94.4 %), respectively (

Topics: Alloys; Diagnostic Errors; Endoscopic Ultrasound-Guided Fine Needle Aspiration; Female; Humans; Male; Middle Aged; Needles; Pancreas; Pancreatic Neoplasms; Quality Improvement; Specimen Handling; 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

A high incidence of migration with covered metal stents has been reported in malignant gastric outlet obstruction (GOO). A newly modified, partially covered, triple-layer nitinol stent was developed that has a longer uncovered portion (5-15 mm) to prevent stent migration.. To estimate the efficacy and safety of the modified covered, triple-layer metal stent.. Multicenter, prospective cohort study.. Three tertiary referral centers.. Fifty consecutive patients (26 with pancreatic carcinoma, 14 with gastric carcinoma, 9 with cholangiocarcinoma, 1 with a metastatic node) who presented with symptomatic unresectable malignant GOO between April 2007 and March 2010.. Endoscopic placement of the modified covered, triple-layer metal stent.. The primary endpoint was to improve the GOO scoring system (GOOSS) score. Secondary endpoints were success rate, patency, and complications.. The median GOOSS score improved significantly (P < .0001) after stenting (from 0 to 3). The technical and clinical success rates were 100% and 90%, respectively. Stent occlusion by tumor overgrowth or ingrowth at the uncovered portion developed in 5 patients (10%). Asymptomatic stent migration occurred in 3 patients (6%) receiving chemotherapy at 95, 230, and 553 days after stent placement, but these patients tolerated solid food 68, 260, and 142 days after stent migration, respectively. Other complications occurred in 1 patient with insufficient expansion, cholangitis, and pancreatitis. No procedure-related deaths occurred.. A single-arm study in tertiary-care centers.. The modified covered, triple-layer metal stent was effective and safe for managing malignant GOO and can prevent tumor ingrowth and stent migration. (. UMIN000004566.).

Topics: Aged; Alloys; Bile Duct Neoplasms; Carcinoma; Cholangiocarcinoma; Female; Gastric Outlet Obstruction; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Pancreatic Neoplasms; Prosthesis Failure; Stents; Stomach Neoplasms

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

A needle made of nitinol has been developed with enhanced flexibility to overcome the limitations of the currently available 19-G EUS-FNA needles.. Evaluate the ability to perform transduodenal FNAs, procure histologic specimens, and undertake therapeutic interventions using the flexible 19-G needle.. Prospective cohort study.. Tertiary-care academic medical center.. Consecutive patients with subepithelial masses, pancreatic head or uncinate lesions, or lesions adjacent to the pancreatic head, and patients undergoing therapeutic intervention.. Perform tissue acquisition and interventions with the flexible 19-G FNA needle.. Evaluate the ability to perform transduodenal passes with the flexible 19-G FNA needle. Also, assess the utility of the needle to yield both cytologic and histologic samples and to perform therapeutic interventions.. Of the 50 patients enrolled, tissue acquisition was undertaken in 38 and therapeutic intervention in 12. Of 38 patients from whom tissue was procured, 32 tissue samples were from pancreatic head/uncinate or peripancreatic masses and 6 were from subepithelial masses. Tissue acquisition, which included transduodenal passes, was successful and adequate for cytologic assessment in all 38 patients (100%). Satisfactory histologic specimens were procured from 36 of 38 (94.7%) patients. An onsite diagnosis was established in 35 of 38 (92.1%) patients. In 3 patients with indeterminate/suspicious lesions, a definitive diagnosis was established at histology. A mean of 1.45 ± 0.79 passes per patient was performed. All 12 therapeutic interventions were successful (100%) and included pseudocyst drainage in 5, pelvic abscess drainage in 2, fiducial placement in 2, celiac plexus neurolysis in 2, and cholangiogram in 1. Needle dysfunction or procedural complications were not encountered.. Single-center study with limited power.. Preliminary data suggest that the flexible 19-G needle can be used for procuring cytologic aspirates and histologic specimens and to undertake therapeutic interventions even by the transduodenal route. Confirmatory studies are required in a larger cohort of patients with varied pathologic conditions to validate these findings.

Topics: Adult; Aged; Alloys; Cohort Studies; Drainage; Endoscopic Ultrasound-Guided Fine Needle Aspiration; Female; Fiducial Markers; Humans; Male; Middle Aged; Needles; Nerve Block; Outcome Assessment, Health Care; Pancreas; Pancreatic Neoplasms; Pancreatitis, Chronic; Pliability; Prospective Studies; Rectal Neoplasms; Stomach Neoplasms

The purpose of this study was to compare the clinical effectiveness of expanded polytetrafluoroethylene/fluorinated-ethylene-propylene (ePTFE/FEP)-covered stents with that of uncovered nitinol stents for the palliation of malignant jaundice caused by inoperable pancreatic head cancer. Eighty patients were enrolled in a prospective randomized study. Bare nitinol stents were used in half of the patients, and ePTFE/FEP-covered stents were used in the remaining patients. Patency, survival, complications, and mean cost were calculated in both groups. Mean patency was 166.0 ± 13.11 days for the bare-stent group and 234.0 ± 20.87 days for the covered-stent group (p = 0.007). Primary patency rates at 3, 6, and 12 months were 77.5, 69.8, and 69.8% for the bare-stent group and 97.5, 92.2, and 87.6% for the covered-stent group, respectively. Mean secondary patency was 123.7 ± 22.5 days for the bare-stent group and 130.3 ± 21.4 days for the covered-stent group. Tumour ingrowth occurred exclusively in the bare-stent group in 27.5% of cases (p = 0.002). Median survival was 203.2 ± 11.8 days for the bare-stent group and 247.0 ± 20 days for the covered-stent group (p = 0.06). Complications and mean cost were similar in both groups. Regarding primary patency and ingrowth rate, ePTFE/FEP-covered stents have shown to be significantly superior to bare nitinol stents for the palliation of malignant jaundice caused by inoperable pancreatic head cancer and pose comparable cost and complications. Use of a covered stent does not significantly influence overall survival rate; nevertheless, the covered endoprosthesis seems to offer result in fewer reinterventions and better quality of patient life.

Topics: Adult; Aged; Alloys; Biliary Tract Surgical Procedures; Coated Materials, Biocompatible; Female; Humans; Jaundice, Obstructive; Male; Middle Aged; Palliative Care; Pancreas; Pancreatic Neoplasms; Polytetrafluoroethylene; Prospective Studies; Prosthesis Design; Prosthesis Implantation; Stents; Survival Analysis; Treatment Outcome

To evaluate the technical and clinical success of percutaneous superior mesenteric vein (SMV) stenting in symptomatic patients using self-expanding nitinol stents.. We retrospectively analyzed the technical and clinical success of percutaneous SMV stenting of 6 symptomatic patients (3 men, mean age 67 years, range 48-81 years). Stenosis of the SMV was caused by postoperative stricture (n=3), pancreas carcinoma (n=1) and pancreatitis (n=2). As a result of the stenosis, 3 patients had symptomatic ascites, 2 patients showed signs of mesenteric ischemia and 1 patient had recurrent gastrointestinal bleeding. Stenting was performed by a percutaneous transhepatic approach using self-expanding nitinol stents.. Stenting of the SMV was technically and clinically successful in all patients. No peri-interventional complications occurred. The stent diameters ranged from 6 to 14 mm. During the mean follow-up of 6 months (range, 2-10 months) 1 patient presented early stent occlusion 2 weeks after placement.. Stenting of a symptomatic SMV stenosis using self-expanding nitinol stents is feasible and clinically effective.

Topics: Aged; Aged, 80 and over; Alloys; Anticoagulants; Ascites; Catheterization; Constriction, Pathologic; Female; Follow-Up Studies; Heparin, Low-Molecular-Weight; Humans; Male; Mesenteric Ischemia; Mesenteric Vascular Occlusion; Mesenteric Veins; Middle Aged; Pancreatic Neoplasms; Pancreatitis; Portal Vein; Postoperative Complications; Punctures; Retrospective Studies; Self Expandable Metallic Stents; Treatment Outcome; Ultrasonography, Doppler, Color

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

Self-expandable metallic stents (SEMS) of varying designs and materials have been developed to reduce complications, but few comparative data are available with regard to the type of stent and the stent manufacturer. We analyzed the success rates and complication rates, according to stent type (uncovered vs. covered stent) and individual stent manufacturer, in malignant colorectal obstruction.. From November 2001 to August 2008, 103 patients were retrospectively included in this study: four types of uncovered stents in 73 patients and two types of covered stents in 30 patients. The SEMS was inserted into the obstructive site by using the through-the-scope method.. Technical and clinical success rates were not different between stent type or among stent manufacturers: 100 and 100% (p = ns) and 100 and 96.6% (p > 0.05), respectively, in uncovered and covered stents. Stent occlusion and migration rates were 12.3 and 3.3% (p = 0.274) and 13.7 and 16.7% (p = 0.761), respectively, in uncovered and covered stents, and 11.1, 5, and 9% (p = 0.761) and 25.9, 15, and 0% (p = 0.037) in Wallstent, Niti-S, and Bonastent uncovered stents, respectively.. The placement of SEMS is an effective and safe treatment for patients with malignant colorectal obstruction. Although minor differences in outcome were detected according to the type and the manufacturer of the stents, no statistically significant difference was observed, except in stent migration among the stent manufacturer.

Topics: Adenocarcinoma; Aged; Aged, 80 and over; Alloys; Carcinoma; Chromium Alloys; Coated Materials, Biocompatible; Cobalt; Colonic Diseases; Colonic Neoplasms; Colonoscopy; Equipment Design; Female; Fluoroscopy; Foreign-Body Migration; Humans; Intestinal Obstruction; Male; Middle Aged; Palliative Care; Pancreatic Neoplasms; Radiography, Interventional; Rectal Diseases; Stents; Stomach Neoplasms; Treatment Outcome; Uterine Cervical Neoplasms

Nitinol self-expanding stents were used in treatment of 15 patients with blastomatous lesions of biliopancreatoduodenal zone. Stenting was successful in all cases, long-term results were obtained in all patients. Death occurred in 8 patients within 5,5-11 month after stent insertion. 7 patients remain under observation. In 6 patients nitinol stents remain open with no signs of occlusion from 2,5 to 15 months' observation period. Jaundice recurred in one patient after 11 month after the insertion due to stent occlusion. Thus, stenting proved to be an effective and safe method of bile flow restoration by tumor biliary tract obstruction.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Bile Duct Neoplasms; Duodenal Neoplasms; Endoscopy, Digestive System; Female; Humans; Jaundice, Obstructive; Male; Middle Aged; Pancreatic Neoplasms; Prosthesis Design; Stents; Treatment Outcome

Self-expandable metal stents (SEMSs) made from nitinol (N) were developed as a potentially more effective alternative to conventional stainless steel (SS) stents.. To compare clinical outcomes of N versus SS stents in the management of malignant biliary strictures.. Retrospective study.. Tertiary-care cancer center.. All patients with first-time N (Flexxus) and SS (Wallstent) uncovered biliary SEMSs placed between January 2006 and October 2007.. SEMS placement.. A total of 81 N and 96 SS stents were placed. The most common cancer diagnosis was pancreatic (80.2% N; 62.5% SS; P = .06). The most frequent site of stricture was the common bile duct (85.2% N; 86.5% SS; P = .31). Biliary decompression was achieved in 93.8% of the N group and 86.4% of the SS group (P = .22). Immediate stent manipulation was required in 4 patients in each group. Subsequent intervention for poor drainage was performed in 17 N (21%) and 26 SS (27%) stents at mean times of 142.1 days (range, 5-541 days; median, 77 days) and 148.1 days (range, 14-375; median, 158.5), respectively (P = .17). The occlusion rate between N and SS stents was not significant (P = .42). The overall durations of stent patency in the N and SS group were similar (median 129 and 137 days, respectively; P = .61), including the subgroup analysis performed on patients with pancreatic cancer (P = .60) and common duct strictures (P = .77). Complication rates were low in both groups (early: 3.7% N, 6.3% SS; late: 2.5% N, 3.1% SS). Ninety percent underwent chemotherapy and 38% radiation therapy in each group.. Retrospective design.. Similar outcomes were achieved with N and SS stents regarding efficacy, duration of stent patency, occlusion rates, and complications. Our results are most applicable to patients with common duct strictures and pancreatic cancer.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Ampulla of Vater; Cholangiocarcinoma; Cholestasis, Extrahepatic; Common Bile Duct Neoplasms; Equipment Failure Analysis; Female; Hepatic Duct, Common; Humans; Liver Function Tests; Liver Neoplasms; Male; Middle Aged; Pancreatic Neoplasms; Prosthesis Design; Recurrence; Retreatment; Retrospective Studies; Stainless Steel; 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

Studies have shown that SEMS remain patient longer with fewer associated complications compared with conventional plastic strents. Zilver stent, a nitinol zig-zag mash SEMS has a special advantage, having a thin introducer diameter of 7 Fr with a fully deployed span of 10mm. For a 48-year-old woman presented with obstructive jaundice and a diagnosis of unresectable pancreatic carcinoma with consequent stenosis of common bile duct (CBD), infiltration of local blood vessels and life expectancy longer than six months, it was decided that an endoscopic palliative drainage procedure should be performed. The technique of transendoscopic plastic to metal stent exchange is described, using a diagnostic duodenoscope. The patient lived 7 months after implementation of Zilver stent and died anicteric due to progression of a primary disease. The transendoscopic plastic to metal stent exchange is feasible palliative method which requires a basic endoscopic equipment and experienced staff and therefore is applicable in developing countries as well.

Topics: Alloys; Common Bile Duct; Duodenoscopes; Duodenoscopy; Female; Humans; Jaundice, Obstructive; Palliative Care; Pancreatic Neoplasms; Plastics; Stents

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

The endoscopic placement of metallic stents for palliation of malignant obstruction of the GI or biliary tract is an established practice and as such is often applied. Use of these stents, however, has its problems. Stent migration may cause obstruction of the bowel lumen. Migration of a biliary stent into the contralateral duodenal wall may cause difficulty in gaining access to the biliary tract, as will the placement of a duodenal stent across the ampulla.. We report on 6 patients in whom trimming of the metallic nitinol stent was performed.. Single-center, retrospective case series.. Secondary referral center.. Of 6 patients included, 2 patients each had an uncovered duodenal stent, 2 had an uncovered biliary stent each, 1 had an uncovered colorectal stent, and 1 had a covered gastroduodenal stent.. Under direct endoscopic vision, an argon plasma beam was used to cut self-expandable metallic stents, as appropriate.. The main objective was relief of the obstruction to the bowel lumen or bile duct, facilitating successful passage of an endoscope or biliary canulation, respectively.. In all 5 patients with uncovered metallic stents, we were able to re-establish access to the obstructed bowel lumen or the biliary tree, as indicated. An attempt to tailor the length of a covered metallic gastroduodenal stent failed. No complications were observed and no hemorrhage or perforation occurred.. The study was limited by retrospective design and small sample size.. The endoscopic cutting and tailoring of an uncovered metallic prosthesis, by means of an argon plasma beam, is feasible, effective, and safe. Trimming of covered stents is not advocated.

Topics: Adenocarcinoma; Aged; Alloys; Argon; Biliary Tract Neoplasms; Device Removal; Electrosurgery; Endoscopy, Gastrointestinal; Female; Foreign-Body Migration; Humans; Intestinal Obstruction; Male; Middle Aged; Pancreatic Neoplasms; Stents

Through-the-scope (TTS) stents facilitate palliative enteral stent placement. However, most TTS stents are braided, a characteristic that has been associated with significant foreshortening and relatively frequent migration.. To evaluate clinical experience with a new woven enteral stent in the treatment of gastric outlet obstruction.. From January 2005 to August 2006, patients with unresectable malignant gastric outlet obstruction were offered stent placement with a new woven stent.. Three referral hospitals in Japan.. Thirty-seven consecutive patients with malignant gastric outlet obstruction.. A newly designed enteral stent was placed by using the TTS placement technique.. Palliation efficacy and safety of the new stents.. Stent placement was successful in 36 of 37 patients (technical success, 97%). Thirty-four patients were able to tolerate oral intake without obstructive symptoms (clinical success, 94.4%). Complications occurred in 16.2% of patients, comprising 2 cases of primary stent dysfunction, 1 perforation, 1 GI bleeding, 1 stent obstruction, and 1 biliary stent dysfunction. No migration was seen during the median follow-up period of 68 days.. Small sample size and relatively brief follow-up.. A newly developed enteral stent with higher flexibility and less foreshortening offers comparable clinical outcome to existing stents and a lower frequency of complications, including migration.

Topics: Aged; Alloys; Equipment Design; Female; Gastric Outlet Obstruction; Humans; Male; Middle Aged; Palliative Care; Pancreatic Neoplasms; Stents; Stomach Neoplasms; Survival Rate

To assess the efficacy of fluoroscopic per oral placement of self-expandable nitinol stents in the palliative treatment of malignant duodenal obstructions.. Under fluoroscopic guidance, 82 patients (56 male and 26 female; mean age, 62.3 y) with malignant duodenal obstructions were treated with per oral placement of four types of self-expandable nitinol stents. All patients presented with severe nausea and recurrent vomiting, and their obstructions were inoperable.. Technical success was achieved in 78 of 82 patients (95.1%). After stent placement, food intake capacity improved in 74 of 78 patients (94.9%). Stent migration occurred in one patient 4 days after placement. A covered stent was placed to cover the ampulla of Vater in 15 patients without external biliary drainage; three of them (20%) became jaundiced. During the mean follow-up period of 74.7 days (range, 9-374 d), eight patients developed recurrent obstructive symptoms caused by tumor ingrowth (n=2) or tumor overgrowth (n=6). They were successfully treated by additional stent placement. The primary stent patency rates were 97.0%, 79.8%, and 44.0% at 30-, 90-, and 180 days, respectively (mean patency, 228.2 d; 95% CI, 153.9-302.5).. Fluoroscopic per oral placement of self-expandable nitinol stents is an effective palliative treatment for malignant duodenal obstructions.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Duodenal Neoplasms; Duodenal Obstruction; Female; Fluoroscopy; Humans; Male; Middle Aged; Palliative Care; Pancreatic Neoplasms; Radiography, Interventional; 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

To investigate the technical feasibility and clinical effectiveness of a polyurethane-covered expandable nitinol stent in the treatment of malignant gastroduodenal obstructions.. The stent was constructed in-house by weaving a single thread of 0.2-mm nitinol wire in a tubular configuration and was covered with polyurethane solution by means of a dipping method. With fluoroscopic guidance, the stent was placed in 19 consecutive patients with malignant gastric outlet obstruction (n = 15) or duodenal obstruction (n = 4). All patients had severe nausea and recurrent vomiting, and their obstructions were inoperable.. Stent placement was technically successful in all but one patient. After stent placement, symptoms improved in all but one patient, who had another stenosis at the proximal jejunum. One patient with stent placement in the second portion of the duodenum became jaundiced. During the mean follow-up of 11 weeks, stent migration occurred in five patients 1-4 days after the procedure. All patients with stent migration were treated by means of placing a second, uncovered nitinol stent. Two of these five patients showed recurrence of stricture because of tumor ingrowth; they underwent coaxial placement of a third, covered nitinol stent with good results.. Placement of a polyurethane-covered expandable nitinol stent seems to be technically feasible and effective for palliative treatment of inoperable malignant gastroduodenal obstructions. Stent migration, however, is problematic and requires further investigation.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Coated Materials, Biocompatible; Duodenal Neoplasms; Duodenal Obstruction; Feasibility Studies; Female; Gastric Outlet Obstruction; Humans; Male; Middle Aged; Palliative Care; Pancreatic Neoplasms; Polyurethanes; Prosthesis Design; Prosthesis Failure; Pyloric Stenosis; Radiography; Stents; Stomach Neoplasms

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