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Study terminated due to low/difficulty enrollment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Yachimski, MD, MPH | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
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2 participants were enrolled (signed consent). However, only 1 participant was randomized and completed the study.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Only 1 participant was ever enrolled on the study, and this participant was randomized to the Lumen Apposing Metal Stent (LAMS) arm. No participants were randomized to the LAMS plus double pigtail stent.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | No participants were randomized to the LAMS plus double pigtail stent arm | Posted | Number | percentage of decrease | 30 days following placement of stent |
|
18 months
Definition of adverse event and/or serious adverse event did not differ from the clinicaltrials.gov definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Terminated due to low/difficulty enrollment. Only one participant was randomized. As a result, originally planned analysis was not completed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sharee Burkeen, Research Program Manager | Vanderbilt University Medical Center | (615) 875-7515 | sharee.k.burkeen@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 2, 2017 | Jul 21, 2021 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D010192 | Pancreatic Pseudocyst |
| ID | Term |
|---|---|
| D010181 | Pancreatic Cyst |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010182 | Pancreatic Diseases |
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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
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|
|
| 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. |
|
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 |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| 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. |
|
|
| 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 | No participants were randomized to LAMS plus double pigtail stent | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 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 | No participants were randomized to the LAMS plus double pigtail stent arm | Posted | Number | number of interventions | 3 months |
|
|
|
| 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 | No participants were randomized to the LAMS plus double pigtail stent arm | Posted | Number | event | 3 months |
|
|
|
| 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 | No participants were randomized to the LAMS plus double pigtail stent arm | Posted | Number | event | 3 months |
|
|
|
| Secondary | Incidence of Early (<30 Days) Endoscopic Reintervention | Incidence of early (<30 days) endoscopic reintervention following initial endoscopic intervention | No participants were randomized to the LAMS plus double pigtail stent arm | Posted | Number | event | 30 days |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 |
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| D004066 |
| Digestive System Diseases |