An interventional study of Endoscopic treatment and Minimally invasive surgical necrosectomy in Necrosis of Pancreas and Infected Pancreatic Necrosis, sponsored by AdventHealth. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-11.
Sponsored by AdventHealth · Not applicable, Interventional, and Treatment
Prospective, randomized controlled trial comparing Endoscopic Ultrasound (EUS) Guided cystogastrostomy or cystoduodenostomy and endoscopic necrosectomy to minimally invasive surgical necrosectomy, in patients with necrotizing pancreatitis.
Patients will be randomly allocated to either treatment arm in a 1:1 ratio. Following intervention, patients will be assessed at regular intervals until study completion at 6 months post-discharge. Primary outcome is a composite of major complications and/or mortality, measured to 6 months post-discharge.
752 studies on the registry are indexed under Pancreatitis; 181 are open to participants now.
This study's enrollment of 69 is below the median of 80 across 448 interventional studies indexed under Pancreatitis.
Browse Pancreatitis studies →AdventHealth is the lead sponsor of 107 studies on the registry; 25 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
Necrotic collection
Exclusion Criteria:
Treated by single or multiple transmural cystogastrostomy tracts, 15mm balloon dilation, two 7 French (Fr) double pigtail plastic stents or lumen-apposing metal stents and nasocystic drainage catheter, with or without endoscopic necrosectomy as needed.
Procedure: Endoscopic treatment
Video-assisted retroperitoneal debridement (VARD) or laparoscopic approach. This includes laparoscopic cystogastrostomy with internal debridement.
Procedure: Minimally invasive surgical necrosectomy
Treated by single or multiple transmural cystogastrostomy tracts, 15mm balloon dilation, two 7fr double pigtail plastic stents or lumen-apposing metal stents and nasocystic drainage catheter, with or without endoscopic necrosectomy as needed.
Also known as: Endoscopic cystogastrostomy, Endoscopic cystoduodenostomy, Endoscopic necrosectomy
Video-assisted retroperitoneal debridement (VARD) or laparoscopic cystogastrostomy with internal debridement.
Also known as: Video-assisted retroperitoneal debridement (VARD), Laparoscopic cystogastrostomy with internal debridement
Major complications
Composite of major complications and/or mortality (all cause and disease specific), measured to 6 months post discharge
Time frame: 6 months post discharge
Plan to share: No
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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