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Biosafety of a novel covered self-expandable metal stent coated with poly(2-methoxyethyl acrylate) in vivo.

ABSTRACT: Covered self-expandable metal stents (CSEMS) are often used for palliative endoscopic biliary drainage; however, the unobstructed period is limited because of sludge occlusion. The present study aimed to evaluate the biosafety of a novel poly(2-methoxyethyl acrylate)-coated CSEMS (PMEA-CSEMS) for sludge resistance and examine its biosafety in vivo. Using endoscopic retrograde cholangiopancreatography, we placed the PMEA-CSEMS into six normal porcine bile ducts and conventional CSEMS into three normal porcine bile ducts. We performed serological examination and undecalcified histological analysis at 1, 3, and 6 months during follow-up. In the bile ducts with PMEA-CSEMS or conventional CSEMS, we observed no increase in liver enzyme or inflammatory marker levels in the serological investigations and mild fibrosis but no inflammatory response in the histopathological analyses. Thus, we demonstrated the biosafety of PMEA-CSEMS in vivo.

SUBMITTER: Ishizawa T

PROVIDER: S-EPMC8462702 | biostudies-literature |

REPOSITORIES: biostudies-literature

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A pilot study of novel duodenal covered self-expandable metal stent fixation.

Project description:Migration of duodenal covered self-expandable metal stents (C-SEMSs) is the main cause of stent dysfunction in patients with malignant gastric outlet obstruction (mGOO). Because endoscopic SEMS placement is frequently selected in patients with poor performance status, we concurrently focused on the safety of the treatment. This pilot study included 15 consecutive patients with mGOO who underwent duodenal partially covered SEMS (PC-SEMS) placement with fixation using an over-the-scope-clip (OTSC). Technical feasibility, clinical success for oral intake estimated by the Gastric Outlet Obstruction Scoring System (GOOSS) score, and adverse events including stent migration were retrospectively assessed. All procedures were successful, and clinical success was achieved in 86.7% (13/15). Mean GOOSS scores were improved from 0.07 to 2.53 after the procedure (P < 0.001). Median survival time was 84 days, and all patients were followed up until death. Stent migration occurred in one case (6.7%) at day 17, which was successfully treated by removal of the migrated PC-SEMS using an enteroscope. For fixation using an OTSC, additional time required for the procedure was 8.9 ± 4.1 min and we did not observe OTSC-associated adverse events. Poor performance status was associated with clinical success (P = 0.03), but we could provide the treatment safely and reduce mGOO symptoms even in patients with poor performance status. In conclusion, duodenal PC-SEMS fixation using an OTSC is feasible for preventing stent migration in patients with mGOO including those with poor performance status.

| S-EPMC8492690 | biostudies-literature

Pancreatic stones treated via an EUS-guided pancreaticogastrostomy with a fully-covered self-expandable metal stent.

Project description:Video 1Pancreatic stones treated via an EUS-guided pancreaticogastrostomy with a fully covered self-expandable metal stent. A 42-year-old man who had undergone a distal pancreatectomy 2 years earlier for chronic pancreatitis due to alcohol use, with pancreatic stones, presented because of severe abdominal pain. Blood tests revealed elevated inflammatory markers and pancreatic enzymes. CT depicted pancreatic stones up to 1 cm in size in the entire pancreatic parenchyma and main pancreatic duct. Obstructive pancreatitis caused by pancreatic stones was diagnosed. Transpapillary removal of the stones was attempted, but the main pancreatic duct could not be approached because of the pancreatic stones near the duodenal papilla. We attempted to approach the main pancreatic duct via the transgastric route with endoscopic ultrasound guidance. CT showed pancreatic stones in the main pancreatic duct.

| S-EPMC8430273 | biostudies-literature

Arterial bleeding during EUS-guided pseudocyst drainage stopped by placement of a covered self-expandable metal stent.

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| S-EPMC3665445 | biostudies-literature

Adhesion and proliferation of human periodontal ligament cells on poly(2-methoxyethyl acrylate).

Project description:Human periodontal ligament (PDL) cells obtained from extracted teeth are a potential cell source for tissue engineering. We previously reported that poly(2-methoxyethyl acrylate) (PMEA) is highly biocompatible with human blood cells. In this study, we investigated the adhesion, morphology, and proliferation of PDL cells on PMEA and other types of polymers to design an appropriate scaffold for tissue engineering. PDL cells adhered and proliferated on all investigated polymer surfaces except for poly(2-hydroxyethyl methacrylate) and poly[(2-methacryloyloxyethyl phosphorylcholine)-co-(n-butyl methacrylate)]. The initial adhesion of the PDL cells on PMEA was comparable with that on polyethylene terephthalate (PET). In addition, the PDL cells on PMEA spread well and exhibited proliferation behavior similar to that observed on PET. In contrast, platelets hardly adhered to PMEA. PMEA is therefore expected to be an excellent scaffold for tissue engineering and for culturing tissue-derived cells in a blood-rich environment.

| S-EPMC4140152 | biostudies-literature

Effectiveness and safety of endoscopic treatment of benign biliary strictures using a new fully covered self expandable metal stent.

Project description:Background. In patients with benign biliary strictures, the use of fully covered self-expandable metal stents (SEMS) has been proposed as an alternative to plastic stenting, but high quality prospective data are sparse. This study was performed to evaluate the long-term effectiveness and safety of a new fully covered SEMS for benign biliary strictures. Methods. All consecutive patients with benign biliary strictures were treated with placement of a fully covered SEMS (WallFlex) for 6 months. Short- and long-term stricture resolution, adverse events, and ease of stent removal were recorded. Results. 23 patients were enrolled. Stricture etiology was chronic pancreatitis (14), postorthotopic liver transplant (4), idiopathic (4), and biliary stones (1). All ERCPs were technically successful. All stents were successfully removed. Short-term stricture resolution was seen in 22/23 (96%) patients. Long-term success was 15/18 (83.3%). All 3 failures were patients with biliary strictures in the setting of chronic calcific pancreatitis. Conclusions. The use of the new SEMS for the treatment of benign biliary strictures led to short-term stricture resolution in the vast majority of patients. Over a long-term followup the success rate appears favorable compared to historical results achieved with multiple plastic stenting, particularly in patients with chronic pancreatitis. The study was registered with ClinicalTrials.gov (NCT01238900).

| S-EPMC3727195 | biostudies-literature

Controlled Separation and Release of Organoiodine Compounds Using Poly(2-methoxyethyl acrylate)-Analogue Microspheres.

Project description:A selective adsorption/desorption of organoiodine compounds was achieved on poly(2-methoxyethyl acrylate)-analogue microspheres, wherein the side chains in the polymers act as halogen-bonding sites. These results demonstrate that the halogen-bonding sites in the side chains exhibit adequate specific affinity for organoiodine compounds. In addition, the water-swollen pMEA-analogue microspheres (microgels) showed a thermoresponsive swelling/deswelling behavior that permitted a controlled release of the organoiodine compounds upon changing the temperature. Thus, it seems plausible that a variety of problems associated with, e.g., the recovery of rare iodine-containing compounds, such as the marine-derived iodine compounds, the delivery of iodine-containing drugs, or the removal of halogen compounds from wastewater, could be resolved by polymer microspheres that exhibit controlled halogen bonding.

| S-EPMC6645105 | biostudies-literature

Anatomy-shaped design of a fully-covered, biliary, self-expandable metal stent for treatment of benign distal biliary strictures.

Project description:The treatment success of benign biliary strictures with fully covered metal stents (CSEMS) is altered by high stent dislocation rates. We aimed to evaluate a new stent design to prevent dislocation.Patients with benign biliary strictures were treated with a newly designed double-coned stent (dcSEMS). Mechanical analysis of the new stent was performed and it was compared with a cylindrical stent.A total of 13 dcCSEMS were implanted in 11 patients (2 female, 9 male, median age 47, range 33 - 71). All patients had distal biliary strictures due to chronic pancreatitis. No stent migration occurred. In all but one patient the stents were removed. One patient refused stent extraction and was lost to follow up. Stent occlusion occurred twice leading to cholangitis in both cases. The duration of stent treatment was 170 days (range 61 - 254). After extraction only one patient had early recurrent stricture and received the same stent again. Three stents showed minimal tissue granulation at the papilla. One stent presented ingrowth at the proximal end and was removed after implantation of a second fully covered stent. Mechanical examination revealed significantly lower radial expansion force of the new stent as compared to the cylindrical stent.The new stent design has a low rate of migration. Biomechanical properties may explain this effect.

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Trial protocol: a randomised controlled trial to verify the non-inferiority of a partially covered self-expandable metal stent to an uncovered self-expandable metal stent for biliary drainage during neoadjuvant therapy in patients with pancreatic cancer with obstructive jaundice (PUN-NAC trial).

Project description:IntroductionNeoadjuvant chemotherapy or neoadjuvant chemoradiotherapy (NAC/NACRT) for resectable/borderline resectable pancreatic cancers was recently performed to improve clinical outcomes and led to good results, although it remains controversial whether NAC/NACRT is beneficial for resectable pancreatic cancer. A few recent studies revealed longer patency and lower cost related to the stent occlusion of a metal stent than those of a plastic stent during NAC/NACRT. It also remains controversial which type of self-expandable metal stent (SEMS) is the most suitable for patients with resectable/borderline resectable pancreatic cancer during NAC/NACRT: an uncovered SEMS (USEMS), a fully covered SEMS (FCSEMS) or a partially covered SEMS (PCSEMS). So far, two randomised controlled trials indicated that a USEMS and an FCSEMS were similar in preoperative stent dysfunction and adverse event rate. Thus, we aimed to verify the non-inferiority of a PCSEMS to a USEMS in this multicentre randomised controlled trial.Methods and analysisWe designed a multicentre randomised controlled trial, for which we will recruit 100 patients with resectable/borderline resectable pancreatic cancer and distal biliary obstruction scheduled for NAC/NACRT from 13 high-volume institutions. Patients will be randomly allocated to the PCSEMS group or USEMS group. The primary outcome measure is the preoperative biliary event rate. Data will be analysed after completion of the study. We will calculate the 95% CIs of the incidence of preoperative biliary events in each group and analyse whether the difference between them is within the non-inferiority margin (10%).Ethics and disseminationThis study has been approved by the institutional review board of Hokkaido University Hospital. The results will be submitted for presentation at an international medical conference and published in a peer-reviewed journal.Trial registration numberUMIN000041737; jRCT1012200002.

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Project description: Not available

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