Clinical Trial: Endoscopic Large Caliber Drainage vs. Complete Necrosectomy for Treatment of Walled-off Pancreatic Necrosis

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Endoscopic Large Caliber Drainage vs. Complete Necrosectomy for Treatment of Walled-off Pancreatic Necrosis: A Prospective, Randomized Noninferiority Trial.

Brief Summary: The purpose of this study is to determine optimal treatment strategies for symptomatic walled-off pancreatic necrosis( WON).

Detailed Summary:
Sponsor: Mayo Clinic

Current Primary Outcome: Complete resolution as defined by complete radiographic resolution of the walled-off necrosis (WON) [ Time Frame: Baseline to 4 months after initiation of endoscopic treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Clinical resolution of infection as defined by complete radiographic resolution and/or symptoms of pain and gastric outlet obstruction [ Time Frame: Baseline to 4 months after initiation of endoscopic treatment ]
  • Symptom resolution (Visual Analogue Scale for pain, gastric outlet obstruction, and weight gain) [ Time Frame: Baseline to 4 months after initiation of endoscopic treatment ]
  • Decrease in incidence of adverse events [ Time Frame: Baseline to 4 months after initiation of endoscopic treatment ]
  • Decrease in number of hospital days during treatment course [ Time Frame: Baseline to 4 months after initiation of endoscopic treatment ]
  • Decrease in total costs of pancreatitis-related health care during treatment course [ Time Frame: Baseline to 4 months after initiation of endoscopic treatment ]


Original Secondary Outcome: Same as current

Information By: Mayo Clinic

Dates:
Date Received: September 29, 2015
Date Started: May 2014
Date Completion: May 2018
Last Updated: September 30, 2015
Last Verified: September 2015