Percutaneous Palliation of Pancreatic Head Cancer: Randomized Comparison of ePTFE/FEP–Covered Versus Uncovered Nitinol Biliary Stents

Abstract

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.

Percutaneous trans-hepatic bilateral biliary stenting in Bismuth IV malignant obstruction

“…Recent data regarding covered metal stents have demonstrated significantly lower re-intervention rates. However, they are associated with complications such as cholecystitis, pancreatitis and stent migration [22,23,27] . The majority of the procedures were performed with a single right-sided access, following the pre-procedural imaging assessment.…”

The Role of ERCP in Pancreatico‐Biliary Malignancies

“…The author custom-made a covered stent from the commercially available Diamond stent, which has been withdrawn from the market since the study. A radiology study found that a percutaneously inserted fully covered SEM (Gore Viabil, Conmed, Utica, NY) had significantly long patency compared to an uncovered SEM in pancreatic cancer (Luminexx Bard Peripheral Vascular, Tempe, AZ) [38] and an uncovered Wallstent in distal cholangiocarcinoma [39]. In summary, the endoscopic results do not clearly show the covered SEMs to be better.…”

Safety and Efficacy of Percutaneous Biliary Covered Stent Placement in Patients with Malignant Biliary Hilar Obstruction; Correlation with Liver Function

“…Bare stents were initially used but encountered some problems, such as stent occlusion by in-stent tumor growth or benign hyperplastic tissue through the wire mesh [17,18,20]. To overcome these problems, the covered biliary stent was developed and showed improved stent patency [21][22][23]. Krokidis et al evaluated 60 patients with extrahepatic cholangiocarcinoma and compared the clinical effectiveness of Viabil covered stents versus uncovered metallic Wallstents.…”