NCT03049215

Lumen Apposing Metal Stents vs Lumen Apposing Metal Stent Plus Double Pigtail Stent for Endoscopic Drainage

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 description

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. Adult patients with symptomatic pancreatic fluid collections who are scheduled to undergo EUS-guided drainage of PFCs with LAMS placement will be eligible for study participation. The initial portion of this procedure consists of diagnostic EUS for imaging and assessment of the PFC. This EUS examination is able to distinguish the relative liquid and solid components of PFCs, detail which may not be evident by CT imaging. Adult patients with PFCs consisting of \>30% solid component as assessed at the time of EUS will be eligible for randomization. This threshold was selected as the enrollment criteria in order to select patients with a significant solid necrotic component to the lesion, as prior study of patients undergoing LAMS placement for drainage of PFCs have used \>70% fluid content as the definition for a PFC with predominantly liquid contents. Allocation to study arm will be determined by the contents of sealed envelope. Subjects randomized to LAMS alone will undergo EUS-guided transmural placement of an Axios stent with a 15 mm luminal diameter. The choice of transgastric or transduodenal LAMS placement will be at the discretion of the endoscopist and contingent upon PFC location and window relative to the EUS transducer. Subjects randomized to LAMS plus double pigtail stent will undergo EUS-guided transmural placement of a single Axios stent with a 15 mm luminal diameter; following this, wire access across the stent lumen will be achieved using a 0.035 inch hydrophilic guidewire, and a double pigtail plastic biliary stent (6 French, 7 French, or 10 French at the discretion of the endoscopist) will be deployed over the wire. The use of fluoroscopy for stent deployment will be at the discretion of the endoscopist. The primary end point: Greater than 50% decrease in size of PFC (in mm), compared to pre-intervention size (in mm), on cross-sectional computed tomography (CT) imaging at 30 days following stent placement. This was selected as the primary outcome in order to maintain consistency with the primary outcomes of a prior multicenter study of LAMS placement for PFCs.

Conditions

• Pancreatic Pseudocyst

Interventions

Type	Name	Description
DEVICE	Lumen Apposing Metal Stent (LAMS)	The AXIOS Stent and Electrocautery-Enhanced Delivery System is an endoscopic device designed to enable the ultrasound trained interventional endoscopist to deliver a transenteric stent between the gastrointestinal tract and a pancreatic pseudocyst.
DEVICE	LAMS plus double pigtail stent	The AXIOS Stent and Electrocautery-Enhanced Delivery System is an endoscopic device designed to enable the ultrasound trained interventional endoscopist to deliver a transenteric stent between the gastrointestinal tract and a pancreatic pseudocyst. The double pigtail stent is a routinely used plastic biliary stent.

Timeline

• Start date: 2017-11-06
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2017-02-09
• Last updated: 2021-08-19
• Results posted: 2021-08-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study