NCT02084537

Minimally Invasive Surgery vs. Endoscopy Randomized (MISER) Trial for Necrotizing Pancreatitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: AdventHealth · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Necrosis of Pancreas
• Infected Pancreatic Necrosis

Interventions

Type	Name	Description
PROCEDURE	Endoscopic treatment	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.
PROCEDURE	Minimally invasive surgical necrosectomy	Video-assisted retroperitoneal debridement (VARD) or laparoscopic cystogastrostomy with internal debridement.

Timeline

• Start date: 2014-04-01
• Primary completion: 2017-12-31
• Completion: 2018-09-30
• First posted: 2014-03-12
• Last updated: 2019-02-11

Locations

1 site across 1 country: United States