nitinol and Colonic-Neoplasms

Emergency surgery for malignant colon obstruction entails relatively high morbidity and mortality rates and typically necessitates a 2-step resection. These problems might be potentially mitigated by placement of a self-expanding metal stent (SEMS) as a bridge to surgery. A nitinol colorectal SEMS may offer several advantages, but available evidence on the utility of this SEMS type remains highly limited.. Our purpose was to evaluate the effectiveness and safety as a bridge to surgery of a nitinol SEMS designed for colorectal use.. Prospective and retrospective multicenter clinical study.. Sixteen European study centers.. Thirty-six patients with malignant colonic obstruction.. Nitinol colorectal SEMS placement.. Technical success in accurate SEMS placement with coverage of the entire stricture length, clinical success in alleviating colonic obstructive symptoms, and bridging to elective surgery.. Technical success was achieved in 97% of patients with a 95% CI of 85% to 100% and clinical success in 81% (95% CI, 64%-92%). Elective surgery was performed in 94% (95% CI, 81%-99%) of patients at a median of 11 days (95% CI, 7-15 days) after SEMS placement. SEMS-related perforation occurred in 3 patients.. No control group was included in this nonrandomized cohort study.. In this first comparatively large clinical study of a nitinol colorectal SEMS as a bridge to surgery, a high proportion of patients successfully proceeded to elective surgery after prior decompression by SEMS placement.

Topics: Adenocarcinoma; Adult; Alloys; Colonic Neoplasms; Decompression, Surgical; Duodenal Diseases; Female; Humans; Intestinal Obstruction; Male; Prospective Studies; Prosthesis Design; Prosthesis Implantation; Retrospective Studies; Stents

Many patients who develop obstructive colonic symptoms secondary to inoperable colorectal cancer will require palliative treatment. A minimally invasive and potentially long-lasting approach is placement of nitinol self-expanding metal stents (SEMS).. To determine the effectiveness and safety of a nitinol SEMS designed for colorectal use in the palliative treatment of malignant colonic obstruction.. Prospective multicenter clinical study.. Nine European study centers.. Forty-four patients with malignant colonic obstruction.. Placement of nitinol SEMS designed for colorectal use.. Technical success, defined as accurate SEMS deployment with adequate stricture coverage, and clinical success, defined as decompression and relief of obstructive colonic symptoms maintained without intervention or serious device-related complications.. Technical success was attained in 95% of patients, with 95% CI 85%-99%. After 6 months, the rate of clinical success was 81%, 95% CI 69%-96%. Survival at 6 months was 67%, 95% CI 54%-84%. Clinical success was maintained until death in 86% of the nonsurvivors. No perforations or SEMS-related deaths occurred.. This investigation was nonrandomized and did not include a control group.. In a large prospective investigation, palliative placement of a nitinol SEMS designed for colorectal use was accomplished with a high rate of technical success. Durable clinical success was achieved in a high proportion of patients with low morbidity.

Topics: Aged; Aged, 80 and over; Alloys; Colon; Colonic Neoplasms; Female; Humans; Intestinal Obstruction; Male; Palliative Care; Prospective Studies; Prosthesis Implantation; Stents; Survival Rate

Self-expandable metal stents (SEMS) are a nonsurgical option for treatment of malignant colorectal obstruction also as a bridge to surgery approach. The new nitinol conformable stent has improved clinical outcomes in these kinds of patients. We report a pilot experience with nitinol conformable SEMS placement as bridge to surgery treatment in patients with colorectal obstruction.. Between April and August 2012, we collected data on colonic nitinol conformable SEMS placement in a cohort of consecutive symptomatic patients, with malignant colorectal obstruction, who were treated as a bridge to surgery. Technical success, clinical success, and adverse events were recorded.. Ten patients (7 male (70%)), with a mean age of 69.2±10.1, were evaluated. The mean length of the stenosis was 3.6±0.6 cm. Five patients (50%) were treated on an emergency basis. The median time from stent placement to surgery was 16 days (interquartile range 7-21). Technical and clinical success was achieved in all patients with a significant early improvement of symptoms. No adverse events due to the SEMS placement were observed.. This pilot study confirmed the important role of nitinol conformable SEMS as a bridge to surgery option in the treatment of symptomatic malignant colorectal obstruction.

Topics: Aged; Alloys; Colonic Neoplasms; Female; Humans; Intestinal Obstruction; Male; Metals; Middle Aged; Pilot Projects; Prospective Studies; Prosthesis Design; Stents; Treatment Outcome

Topics: Aged; Alloys; Colonic Diseases; Colonic Neoplasms; Colonoscopy; Female; Hospitals, Military; Humans; Intestinal Obstruction; Male; Middle Aged; Morocco; Palliative Care; Radiography, Interventional; Retrospective Studies; Stents

Non-vascular drug-eluting stents have been studied for the treatment of gastrointestinal cancer and cancer-related stenosis. In this study, we designed and evaluated a gemcitabine (GEM)-eluting covered nonvascular stent. Polyurethane (PU)/polytetrafluoroethylene (PTFE) film was selected for the drug loading and eluting membrane. The membrane was fabricated by dip-coating on a Teflon bar (∅; 10mm), air-dried, peeled off and applied to a self-expanding Nitinol stent. Various amounts of poloxamer 407 (PL, Lutrol F127, BASF) (8%, 10%, or 12% of PU by weight) were added to control the release of GEM from membranes. The membrane containing 12% PL (GEM-PU-PL12%) showed the most favourable release properties; 70% of the loaded GEM released within 35 days, including the 35% released during the initial burst. The biological activities of GEM-PU-PL12% were evaluated using human cholangiocarcinoma cells (SK-ChA-1). GEM-PU-PL12% most efficiently inhibited the proliferation of cholangiocarcinoma cells and most highly induced pro-inflammatory cytokines (TNF-α, IL-1β and IL-12) and p38 MAPKs in the cells. Subtumoural insertion of the GEM-PU-PL12% membrane more efficiently inhibited the growth of CT-26 colon cancer than other membranes. In this study, the GEM-eluting metal stents covered with PU-PL12% showed considerable feasibility for the treatment of malignant gastrointestinal cancer as well as cancer-related stenosis.

Topics: Alloys; Animals; Antimetabolites, Antineoplastic; Cell Count; Cell Proliferation; Cell Survival; Colonic Neoplasms; Constriction, Pathologic; Cytokines; Deoxycytidine; Drug-Eluting Stents; Gastrointestinal Neoplasms; Gemcitabine; Humans; Membranes, Artificial; Mice; p38 Mitogen-Activated Protein Kinases; Poloxamer; Polymers; Polytetrafluoroethylene; Polyurethanes

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

A 6F endoscopic biliary self-expanding metal stent (SEMS) has been newly introduced for intended simultaneous side-by-side bilateral deployment in hilar malignant obstruction.. To report our initial experience with the Zilver 635 biliary SEMS.. Retrospective chart review.. Tertiary referral medical center.. Sixteen consecutive malignant hilar biliary obstruction patients.. Endoscopic palliative treatment of malignant biliary obstruction with the Zilver 635 SEMS from December 2008 to January 2010.. Technical/functional success rates, early complications (within 30 days of stent placement), early/late stent occlusion, and biliary reintervention rates.. A total of 49 Zilver SEMSs were placed in 16 patients (mean age 61 years, 6 men) for Bismuth type II (n = 4), III (n = 5), and IV (n = 7) lesions. Twelve had cholangiocarcinoma, 2 had metastatic colon cancer, 1 had lung cancer, and 1 had pancreatic cancer. The technical success rate was 100%. Side-by-side simultaneous bilateral stent deployment was required and was achieved successfully in 10 cases. Additional transpapillary stents were placed for potential future biliary access. The 30-day mortality rate was 0%. There were 1 early (6%) and 3 late (19%) stent occlusions. Successful overall biliary drainage was 75%.. Small sample size, uncontrolled retrospective study.. Malignant hilar biliary obstruction endoscopic palliation with the Zilver 635 SEMS offers acceptable initial feasibility, safety, and efficacy profiles. The current design facilitates smaller bile duct negotiation and more precise intrahepatic placement. Expanding available lengths would allow transpapillary bridged bilateral SEMS placement for future reobstructed biliary access. Further long-term studies are required for comparative outcomes with other current SEMS technology.

Topics: Adult; Aged; Alloys; Bile Duct Neoplasms; Cholangiocarcinoma; Cholangiopancreatography, Endoscopic Retrograde; Cholestasis, Intrahepatic; Colonic Neoplasms; Duodenoscopes; Equipment Design; Female; Follow-Up Studies; Humans; Liver Neoplasms; Male; Middle Aged; Palliative Care; Retrospective Studies; Stents

Self-expanding metal stents (SEMSs) can alleviate malignant colonic obstruction and avoid emergency decompressive surgery. The use of colonic larger-diameter SEMSs may improve bowel function and reduce migration risk.. To evaluate the effectiveness and safety of a novel large-diameter SEMS (WallFlex) designed for delivery through the endoscope in treating malignant colonic obstruction.. Prospective clinical cohort study.. Two Italian study centers.. Forty-two consecutive patients with malignant colonic obstruction: 23 requiring palliation and 19 bridging to surgery.. Colorectal SEMS placement.. Technical success, defined as accurate SEMS deployment across the stricture on the first attempt; clinical success, ie, complete relief of bowel obstruction without complications; and bridging to surgery, denoting the performance of elective one-stage surgery.. The rate of technical success was 93% (95% CI, 81%-99%) and of initial clinical success was 95% (95% CI, 84%-99%). In 58% (95% CI, 40%-84%) of the palliation group, clinical success was maintained after 6 months. All 19 patients with operable tumors were successfully bridged to one-stage elective surgery within a median of 5 days. One perforation and one stent migration occurred. All complications could be resolved nonsurgically.. No control group was included.. In a prospective study of through-the-scope WallFlex stent placement for malignant colonic obstruction, high rates of technical and initial clinical success, and bridging to surgery were achieved. Complications could be readily managed.

Topics: Adenocarcinoma; Aged; Aged, 80 and over; Alloys; Colon, Sigmoid; Colonic Neoplasms; Constriction, Pathologic; Female; Humans; Intestinal Obstruction; Male; Middle Aged; Prospective Studies; Prosthesis Design; Sigmoid Diseases; 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

The authors implanted a duodenal stent in a woman with a high-grade duodenal stenosis due to inoperable tumor compression. A flexible self-expanding knitted nitinol stent that conformed to the shape of the duodenum was introduced orally to keep the duodenal passage patent. After stent implantation, repeated vomiting stopped and the patient was able to eat and drink. This technique resolved the patient's duodenal stenosis.

Topics: Adenocarcinoma; Alloys; Colonic Neoplasms; Constriction, Pathologic; Duodenal Obstruction; Equipment Design; Female; Humans; Middle Aged; Palliative Care; Radiography, Interventional; Stents