Clinical Trial: Lumen Apposing Metal Stents vs Lumen Apposing Metal Stent Plus Double Pigtail Stent for Endoscopic Drainage of Pancreatic Fluid Collections

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

Official Title: Lumen Apposing Metal Stents vs Lumen Apposing Metal Stent Plus Double Pigtail Stent for Endoscopic Drainage of Pancreatic Fluid Collections: a Randomized Controlled Trial

Brief Summary: The study hypothesis is that placement of LAMS plus an overlapping double pigtail stent for endoscopic transmural drainage of PFCs with solid debris will result in improved drainage and require fewer endoscopic interventions compared to placement of LAMS alone.

Detailed Summary:
Sponsor: Vanderbilt University Medical Center

Current Primary Outcome: Decrease in Pancreatic Fluid Collection (PFC) [ Time Frame: 30 days following placement of stent ]

Greater than 50% decrease in size of PFC (in mm) compared to pre-intervention size (in mm)


Original Primary Outcome: Same as current

Current Secondary Outcome: Clinical Success Rate for Draining of PFC [ Time Frame: 3 months ]

Complete resolution of PFC on follow-up CT imaging


Original Secondary Outcome: Same as current

Information By: Vanderbilt University Medical Center

Dates:
Date Received: February 7, 2017
Date Started: July 2017
Date Completion: December 31, 2020
Last Updated: May 16, 2017
Last Verified: May 2017