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

NCT ID: NCT03049215

Last Updated: 2021-08-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-06
• Study Completion Date: 2019-12-31

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lumen Apposing Metal Stent (LAMS)

Subjects randomized to LAMS alone will undergo EUS-guided transmural placement of an Axios stent with a 15 mm luminal diameter.

Group Type: ACTIVE_COMPARATOR

Lumen Apposing Metal Stent (LAMS)

Intervention Type: DEVICE

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.

LAMS plus double pigtail stent

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.

Group Type: ACTIVE_COMPARATOR

LAMS plus double pigtail stent

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Axios Stent

Eligibility Criteria

Inclusion Criteria

• Male and Female patients between the ages of 18 and 80
• Must be presenting with symptomatic pancreatic fluid collections
• Scheduled to undergo endoscopic ultrasound (EUS)-guided drainage of PFCs with LAMS placement at Vanderbilt Medical Center as part of routine care
• Willing and able to give informed consent

Exclusion Criteria

• Unwilling/unable to give informed consent
• Patients with PFCs consisting of < 30% solid component as assessed at the time of EUS

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Patrick Yachimski

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patrick Yachimski, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

170247

Identifier Type: -

Identifier Source: org_study_id