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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pancreatic Pseudocyst

Intervention / Treatment
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* Device: Lumen Apposing Metal Stent (LAMS)
* Device: LAMS plus double pigtail stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lumen Apposing Metal Stent (LAMS)<br>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)<br>* 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.<br>* Other names: Axios Stent;|
| Active Comparator: LAMS plus double pigtail stent<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Success Rate for Draining of Pancreatic Fluid Collection (PFC) | Clinical success for drainage of PFC, defined as complete resolution of PFC on follow-up computed tomography (CT) imaging and stent removal within 3 months | 3 months | 
| Number of Endoscopic Interventions Required for Resolution of PFC Prior to Stent Removal | Number of endoscopic interventions required for resolution of Pancreatic Fluid Collection (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 | Incidence of hospital readmissions following initial endoscopic intervention and prior to resolution of Pancreatic Fluid Collection (PFC) stent removal | 3 months | 
| Incidence of Surgical or Percutaneous Radiologic Intervention for PFC Following Initial Endoscopy Intervention | Incidence of surgical or percutaneous radiologic intervention for Pancreatic Fluid Collection (PFC) following initial endoscopy intervention | 3 months | 
| Incidence of Early (<30 Days) Endoscopic Reintervention | Incidence of early (<30 days) endoscopic reintervention following initial endoscopic intervention | 30 days |