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

NCT03049215 | Terminated Results FDA Device

• 1 other identifier: 170247
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Pseudocyst

Outcome Measures

Primary Outcomes (1)

• Decrease in Pancreatic Fluid Collection (PFC)

  Greater than 50% decrease in size of PFC (in mm) compared to pre-intervention size (in mm) as measured on cross-sectional computed tomography (CT) imaging

  30 days following placement of stent

Secondary Outcomes (5)

• Clinical Success Rate for Draining of Pancreatic Fluid Collection (PFC)

  3 months

• Number of Endoscopic Interventions Required for Resolution of PFC Prior to Stent Removal

  3 months

• Incidence of Hospital Readmissions Following Initial Endoscopic Intervention and Prior to Resolution of Pancreatic Fluid Collection Stent Removal

  3 months

• Incidence of Surgical or Percutaneous Radiologic Intervention for PFC Following Initial Endoscopy Intervention

  3 months

• Incidence of Early (<30 Days) Endoscopic Reintervention

  30 days

Study Arms (2)

Lumen Apposing Metal Stent (LAMS)

ACTIVE COMPARATOR

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

Device: Lumen Apposing Metal Stent (LAMS)

LAMS plus double pigtail stent

ACTIVE COMPARATOR

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.

Device: LAMS plus double pigtail stent

Interventions

Lumen Apposing Metal Stent (LAMS) 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.

Also known as: Axios Stent

Lumen Apposing Metal Stent (LAMS)

LAMS plus double pigtail stent 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.

LAMS plus double pigtail stent

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Pancreatic Pseudocyst

Condition Hierarchy (Ancestors)

Pancreatic Cyst; Cysts; Neoplasms; Pancreatic Diseases; Digestive System Diseases

Limitations and Caveats

Terminated due to low/difficulty enrollment. Only one participant was randomized. As a result, originally planned analysis was not completed.

Results Point of Contact

• Title: Sharee Burkeen, Research Program Manager
• Organization: Vanderbilt University Medical Center

sharee.k.burkeen@vumc.org

(615) 875-7515

Study Officials

• Patrick Yachimski, MD, MPH

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Subjects will be randomized to either: LAMS alone and undergo EUS-guided transmural placement of an Axios stent with a 15 mm luminal diameter or LAMS plus double pigtail stent and undergo EUS-guided transmural placement of a single Axios stent with a 15 mm luminal diameter

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: February 9, 2017
• Study Start: November 6, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: August 19, 2021
• Results First Posted: August 19, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)