View clinical trials related to Walled Off Necrosis.
Filter by:Although metal stents have been widely used in the endoscopic step-up approach for necrotizing pancreatitis, the exact timing of transmural stent removal has not been well studied. In this prospective, open-label, randomized controlled study, we recruited and enrolled consecutive patients with necrotizing pancreatitis undergoing endoscopic transmural necrosectomy. Eligible participants were randomly assigned to case group (a novel strategy in which the stents were removed during the last necrosectomy when the necrosectomy endpoint was achieved) and control group (the conventional strategy in which the stents were removed after the last necrosectomy when clinical symptoms were relieved and fluid was nearly completely resolved confirmed by imaging). The primary endpoint was the incidence of composite complications within three months of enrollment.
Introduction: Walled off necrosis (WON) is defined as a well circumscribed pancreatic and/or peri pancreatic necrosis containing a variable amount of necrotic tissue. WON usually occurs >4 weeks after onset of necrotizing pancreatitis. It is associated with significant morbidity and mortality especially if infected. Symptomatic WON should be drained either percutaneously, endoscopically or surgically. Minimal invasive approaches are being increasingly used for effective management of WON as it is associated with less adverse events. Various recent studies have shown that endoscopic approach have improved clinical outcome, less hospital stay and lower cost compared to surgical approach. Endoscopic ultrasound guided drainage of WON with either plastic stents or lumen apposing metal stents (LAMS) is mainstay of WON management. A systemic review based on retrospective comparative studies showed no difference regarding treatment success for WON by plastic or metal stents6. However, metal stent had shorter procedure time. A Single center RCT from USA comparing LAMS vs multiple plastic stents for WON has shown that except shorter procedure duration, there was no significant difference in treatment outcomes. To minimize LAMS related adverse events, it should be removed within 3 weeks. However, in the same study 25.8% patients of LAMS group and 55.2% patients of plastic stent group underwent additional intervention within 72 hours for persistent symptoms. Larger diameter, specific stent designs to reduce adverse events should have better outcome with LAMS as compared to plastic stents. Primary outcome of this single center randomized controlled trial is to examine whether dedicated NAGI bi-flanged metal stents (BFMS) are superior to plastic stent in terms of short term and long term success. Aims and Hypothesis: The aim of the current study is to study whether NAGI BFMS are superior to plastic stent in terms of short term and long term success in the EUS guided drainage of WON. The investigators hypothesize that the clinical success with NAGI BFMS would be better than plastic stents in the EUS guided drainage of WON.