Tracking ENcapsulation of Pancreatic Collections in Acute Necrotizing Pancreatitis
Acute Necrotizing PancreatitisThe goal of this study is to investigate the encapsulation of fluid collections in patients with ANP using serial MRI. The main questions it aims to answer are: Evaluating the timing of encapsulation of necrotic fluid collection using serial non-enhanced MRI. Identifying the factors that affect the timing of encapsulation of necrotic fluid collections Participants will undergo serial MRI scans (all with the same protocol) performed starting at day 15. Subsequent scans will be performed at 5 days interval till the clinically significant encapsulation (for all the collections in an individual patient) is seen or patients are excluded from the protocol due to intervention.
Study of a Lumen- Apposing, Covered, Self-Expanding Metal Stent (Axios™) Versus Multiple Double...
Pancreatic NecrosisThe present study aims to compare the clinical efficacy and cost effectiveness of the AXIOS™ stent versus the "conventional" approach using double pigtail plastic stents in the treatment of patients with walled-off pancreatic necrosis.
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Investigation of GSK3335065 Intravenous...
PancreatitisAcute NecrotizingGSK3335065 is being developed as a treatment for acute pancreatitis with the intent of reducing 3-hydroxykynurenine (3HK) levels to the normal range (or lower) and maintaining them at this level throughout the treatment period. This study will utilize an adaptive design and is divided into 3 parts. Part A will consist of 8 cohorts (1-8) and is Single Ascending Dose (SAD) of GSK3335065 by IV bolus in males. Part B will be initiated after completion of dosing in Part A. It will involve ascending IV bolus doses of GSK3335065 followed by IV constant infusion for 7 days in males and will consist of four cohorts (9-12). Part C consists of a single dose of GSK3335065 by IV bolus (cohort 13), and a single dose followed by continuous infusion over 7 days (cohort 14) in females of non-child bearing potential (WONCBP). Total 64 subjects will be evaluated in the study of which Part A will include 16 healthy male subjects, Part B will include 32 healthy male subjects and Part C will include 16 WONCBP. In Part A, cohorts 1 and 2 will last up to 19 weeks and cohorts 3 to 8 will last up to 7 weeks and Part B will last up to 13 weeks. In Part C cohort 7 will last up to 7 weeks and cohort 8 will last for 13 weeks.
COMPARISON OF OUTCOMES OF BI-FLANGED METAL STENT ALONE VERSUS BI-FLANGED METAL STENT WITH CO-AXIAL...
ENDOSCOPIC ULTRASONOGRAPHYEndoscopic ultrasound guided drainage of WON with metal stent is the mainstay of WON management. But there are few complications related to BFMS , like bleeding due to vessel erosion, stent clogging , stent migration . This study is to assess, whether placing an anchoring DPS through the BFMS will decrease adverse events or not. There are only 2 retrospective studies till date ,comparing LAMS with coaxial stent vs LAMS alone. one study showed no significant decrease in adverse events , one study showed decrease in adverse events when DPS with LAMS . But there has been no prospective RCT to assess the utility of DPS to date
EUS-guided Transmural Drainage of Walled-off Pancreatic Necrosis: Plastic vs Metallic Protesis....
Pancreas NecrosisPancreatic CollectionRandomized multicenter study comparing plastic stents and self-expanding metallic stents in the eus-guided transmural drainage of walled-off pancreatic necrosis. Spanish centers partners of the spanish society of digestive endoscopy.
EUS-guided Transenteric Drainage With a Novel Lumen-apposing Metal Stent
Pancreatic PseudocystPancreatic Necrosis2 moreTo evaluate clinical efficacy and safety of a novel lumen-apposing FCSEMS for EUS-guided transenteric drainage of PFC or of biliary tree including GB
EndoRotor DEN (Direct Endoscopic Necrosectomy)Trial
Acute Pancreatic NecrosisAcute Pancreatitis1 moreA prospective, single arm, open label, multi-center, trial to evaluate the safety and effectiveness of the Interscope EndoRotor® Resection System in subjects requiring direct endoscopic necrosectomy (DEN) with walled off pancreatic necrosis (WOPN).
Impact of Transmural Plastic Stent on Recurrence of Pancreatic Fluid Collection After Metal Stent...
Acute Pancreatitis NecrotizingWalled of necrosis (WON) is severe local complication of acute necrotizing pancreatitis. Disconnected pancreatic duct syndrome(DPDS) is commonly seen (50-60%) after necrotizing pancreatitis and has long term implication like recurrent pancreatic fluid collections (PFC)] requiring re-intervention. Incidence of recurrent PFC is more common in patients with DPDS (17-50%) compared to others. Studies has shown permanent in-dwelling transmural stent reduces recurrence of PFC (1.7% vs 17.4%, p<0.001). Nowadays,WON is effectively managed with endoscopic step up approach (96%). Several studies showed dedicated self-expandable metal stent (SEMS) are effective compared to the plastic stents in management of WON with decreased need of re-intervention. However, SEMS cannot be kept for longer duration because of associated adverse events. So, experts recommend to remove SEMS within 4-6 weeks of placement. Considering this background, study is planned with aim to see the effect of transmural plastic stenting on recurrence of PFC after SEMS removal in walled off necrosis with DPDS.
AXIOS Lumen Apposing Metal Stent for Walled Off Necrosis Drainage IDE Study
Walled Off Pancreatic NecrosisTo demonstrate safety and effectiveness of lumen-apposing metal stents for resolution of walled off pancreatic necrosis (WONs) in patients with WONs with solid component >30%.
Comparison of FCSEMS and Plastic Stents
Infected Pancreatic NecrosisAcute Pancreatic Fluid Collection3 moreThe research design is a randomized prospective clinical trial comparing Endoscopic ultrasound (EUS) guided drainage of WON using FCSEMS and plastic stents. The trial will be conducted at the Florida Hospital Center for Interventional Endoscopy, Orlando, Florida.