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A Multicenter, Prospective Study of EUS-Guided Transluminal Gallbladder Drainage in Patients with Acute Cholecystitis as an Alternative to Percutaneous Gallbladder Drainage

Primary Outcome Measures 1.Resolution of Acute Cholecystitis [ Time Frame: Up to 15 weeks ] Time to resolution of acute cholecystitis measured in days. Resolution is defined as either a fever of less than 100.5°F, or at least a 4-point decrease in the pain score, or WBC count less than 12,000/cc, with improvement in at least two of these categories without the deterioration of the third category. Secondary Outcome Measures 1.Rate of re-interventions [ Time Frame: Through study completion, Up to 15 weeks ] Rate of re-interventions including but not limited to stent migration, stent occlusion by GB stones, and luminal debridement. Other Outcome Measures: 1.Stent Patency [ Time Frame: Intraoperative (Stent placement through stent removal) ] Stent patency (ability to facilitate gallbladder drainage) defined indirectly as resolution of acute cholecystitis or, in the absence of resolution of acute cholecystitis, endoscopic observation of unobstructed AXIOS stent lumen 2.Technical stent placement success [ Time Frame: Intraoperative (stent placement) ] Technical AXIOS stent placement success, defined as transmural placement of the AXIOS stent with confirmed stent patency via (i) drainage visualized through the stent or fluoroscopically, or (ii) ability to endoscopically observe the inner walls of the gallbladder through the AXIOS stent 3.Technical stent removal success [ Time Frame: Intraoperative (stent removal) ] Technical stent removal success, defined as the ability to remove the AXIOS stent endoscopically without stent removal related serious adverse events 4.Acute Cholecystitis recurrence [ Time Frame: Through study completion, up to 15 weeks ] Recurrence of acute cholecystitis and its management post AXIOS stent removal 5.Number of cumulative hospital and ICU days [ Time Frame: Through study completion, up to 15 weeks ] Number of cumulative hospital and ICU days from initial stent placement to resolution of symptoms of acute cholecystitis



Recruitment Status

Past Studies