Pancreatic Pseudocyst
Conditions
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.
Interventions
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.
DEVICELAMS 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.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decrease in Pancreatic Fluid Collection (PFC) | 30 days following placement of stent | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success Rate for Draining of Pancreatic Fluid Collection (PFC) | 3 months | 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 |
| Number of Endoscopic Interventions Required for Resolution of PFC Prior to Stent Removal | 3 months | Number of endoscopic interventions required for resolution of Pancreatic Fluid Collection (PFC) prior to stent removal |
| Incidence of Hospital Readmissions Following Initial Endoscopic Intervention and Prior to Resolution of Pancreatic Fluid Collection Stent Removal | 3 months | Incidence of hospital readmissions following initial endoscopic intervention and prior to resolution of Pancreatic Fluid Collection (PFC) stent removal |
| Incidence of Surgical or Percutaneous Radiologic Intervention for PFC Following Initial Endoscopy Intervention | 3 months | Incidence of surgical or percutaneous radiologic intervention for Pancreatic Fluid Collection (PFC) following initial endoscopy intervention |
| Incidence of Early (<30 Days) Endoscopic Reintervention | 30 days | Incidence of early (\<30 days) endoscopic reintervention following initial endoscopic intervention |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from patient population at the Vanderbilt Digestive Disease Center. One participant was enrolled on November 6, 2017, however they were not randomized. A second participant was enrolled in June 2018. No other participants were enrolled.
Pre-assignment details
2 participants were enrolled (signed consent). However, only 1 participant was randomized and completed the study.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 1 |
| 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.
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. | 0 |
| Total | 1 |
Baseline characteristics
| Characteristic | Total | Lumen Apposing Metal Stent (LAMS) |
|---|---|---|
| Age, Continuous | 62 Years STANDARD_DEVIATION 0 | 62 Years STANDARD_DEVIATION 0 |
| Race and Ethnicity Not Collected | 0 Participants | — |
| Region of Enrollment United States | 1 participants | 1 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 0 |
| other Total, other adverse events | 0 / 1 | 0 / 0 |
| serious Total, serious adverse events | 0 / 1 | 0 / 0 |
Outcome results
Primary
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
Time frame: 30 days following placement of stent
Population: No participants were randomized to the LAMS plus double pigtail stent arm
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lumen Apposing Metal Stent (LAMS) | Decrease in Pancreatic Fluid Collection (PFC) | 64 percentage of decrease |
Secondary
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
Time frame: 3 months
Population: No participants were randomized to LAMS plus double pigtail stent
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lumen Apposing Metal Stent (LAMS) | Clinical Success Rate for Draining of Pancreatic Fluid Collection (PFC) | 1 Participants |
| LAMS Plus Double Pigtail Stent | Clinical Success Rate for Draining of Pancreatic Fluid Collection (PFC) | 0 Participants |
Secondary
Incidence of Early (<30 Days) Endoscopic Reintervention
Incidence of early (\<30 days) endoscopic reintervention following initial endoscopic intervention
Time frame: 30 days
Population: No participants were randomized to the LAMS plus double pigtail stent arm
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lumen Apposing Metal Stent (LAMS) | Incidence of Early (<30 Days) Endoscopic Reintervention | 1 event |
Secondary
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
Time frame: 3 months
Population: No participants were randomized to the LAMS plus double pigtail stent arm
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lumen Apposing Metal Stent (LAMS) | Incidence of Hospital Readmissions Following Initial Endoscopic Intervention and Prior to Resolution of Pancreatic Fluid Collection Stent Removal | 1 event |
Secondary
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
Time frame: 3 months
Population: No participants were randomized to the LAMS plus double pigtail stent arm
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lumen Apposing Metal Stent (LAMS) | Incidence of Surgical or Percutaneous Radiologic Intervention for PFC Following Initial Endoscopy Intervention | 0 event |
Secondary
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
Time frame: 3 months
Population: No participants were randomized to the LAMS plus double pigtail stent arm
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lumen Apposing Metal Stent (LAMS) | Number of Endoscopic Interventions Required for Resolution of PFC Prior to Stent Removal | 2 number of interventions |