4645 A prospective, randomized trial of new covered biliary metal stent versus uncovered wallstent for malignant biliary obstruction.

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Introduction: For the patients with biliary obstruction caused by unresectable malignant tumors, palliative biliary drainage is necessary not only for preventing cholangitis or hepatic failure but also for the optimization of the quality of life, being the mainstay of treatment in those patients.The self-expandable metal stent, with its larger diameter, may provide long-term patency and more effective drainage compared to the plastic stent and, therefore, is nowadays being widely used. The metal stents, however, also have some pitfalls that uncovered stents cannot prevent tumor ingrowth and membrane- covered stents may migrate. The purpose of this study was to compare the safety and effectiveness of a newly designed covered stent (Niti-S, Solbit, Seoul, Korea) and uncovered stent (Wallstent, Schneider, Bulach, Switzerland). Method: In a prospective randomized trial, 31 patients with malignant biliary obstruction received either a Niti-S stent(N=17) or a Wallstent(N=14) by the endoscopic transpapillary route and were regularly followed. Result: Placements of metal stents were technically feasible in all patients and there were no procedure-related acute complications. Effective biliary decompression was initially achieved in all patients.The mean follow-up duration was 125 days for Niti-S stent and 121 days for Wallstent. Cholangitis developed in a patient with a Niti-S stent after 5 months but resolved in a couple of days. Stent occlusion occurred in two patients, one with Niti-S stent and the other with Wallstent at 205 days and 224 days after stent insertion, respectively. The causes of stent occlusions were biliary incrustation in the former patient and epithelialization inside the stent in the latter case. The occluded Niti-S stent was easily removed endoscopically and a new Niti-S stent could be reinserted. For the occluded Wallstent, however, we could not attempt to remove it because the stent mesh was fully buried in the bile duct epithelium. Stent migration did not occur in any patients. The median survival of the patients was 175 days after stent insertion. At the time of death, the stents were patent in all patients.Conclusion: Though there are no differences in the feasibility of insertion, biliary decompression, patency duration, or complication rates between two groups, the membrane-covered Niti-S stent has the advantage that it can be removed in case of occlusion. However, longer follow-up and more experience will be needed. Introduction: For the patients with biliary obstruction caused by unresectable malignant tumors, palliative biliary drainage is necessary not only for preventing cholangitis or hepatic failure but also for the optimization of the quality of life, being the mainstay of treatment in those patients.The self-expandable metal stent, with its larger diameter, may provide long-term patency and more effective drainage compared to the plastic stent and, therefore, is nowadays being widely used. The metal stents, however, also have some pitfalls that uncovered stents cannot prevent tumor ingrowth and membrane- covered stents may migrate. The purpose of this study was to compare the safety and effectiveness of a newly designed covered stent (Niti-S, Solbit, Seoul, Korea) and uncovered stent (Wallstent, Schneider, Bulach, Switzerland). Method: In a prospective randomized trial, 31 patients with malignant biliary obstruction received either a Niti-S stent(N=17) or a Wallstent(N=14) by the endoscopic transpapillary route and were regularly followed. Result: Placements of metal stents were technically feasible in all patients and there were no procedure-related acute complications. Effective biliary decompression was initially achieved in all patients.The mean follow-up duration was 125 days for Niti-S stent and 121 days for Wallstent. Cholangitis developed in a patient with a Niti-S stent after 5 months but resolved in a couple of days. Stent occlusion occurred in two patients, one with Niti-S stent and the other with Wallstent at 205 days and 224 days after stent insertion, respectively. The causes of stent occlusions were biliary incrustation in the former patient and epithelialization inside the stent in the latter case. The occluded Niti-S stent was easily removed endoscopically and a new Niti-S stent could be reinserted. For the occluded Wallstent, however, we could not attempt to remove it because the stent mesh was fully buried in the bile duct epithelium. Stent migration did not occur in any patients. The median survival of the patients was 175 days after stent insertion. At the time of death, the stents were patent in all patients.Conclusion: Though there are no differences in the feasibility of insertion, biliary decompression, patency duration, or complication rates between two groups, the membrane-covered Niti-S stent has the advantage that it can be removed in case of occlusion. However, longer follow-up and more experience will be needed.