Trial Outcomes & Findings for Lumen Apposing Metal Stents vs Lumen Apposing Metal Stent Plus Double Pigtail Stent for Endoscopic Drainage (NCT NCT03049215)

Results Overview

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

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

30 days following placement of stent

Results posted on

2021-08-19

Participant Flow

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.

2 participants were enrolled (signed consent). However, only 1 participant was randomized and completed the study.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	1	0
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lumen Apposing Metal Stent (LAMS) n=1 Participants 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.	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.	Total n=1 Participants Total of all reporting groups
Age, Continuous	62 Years STANDARD_DEVIATION 0 • n=1 Participants	—	62 Years STANDARD_DEVIATION 0 • n=1 Participants
Sex: Female, Male Female	1 Participants n=1 Participants	—	1 Participants n=1 Participants
Sex: Female, Male Male	0 Participants n=1 Participants	—	0 Participants n=1 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	1 participants n=1 Participants	—	1 participants n=1 Participants

PRIMARY outcome

Timeframe: 30 days following placement of stent

Population: No participants were randomized to the LAMS plus double pigtail stent arm

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

Outcome measures

Outcome measures
Measure	Lumen Apposing Metal Stent (LAMS) n=1 Participants 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.	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.
Decrease in Pancreatic Fluid Collection (PFC)	64 percentage of decrease	—

SECONDARY outcome

Timeframe: 3 months

Population: No participants were randomized to LAMS plus double pigtail stent

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

Outcome measures

Outcome measures
Measure	Lumen Apposing Metal Stent (LAMS) n=1 Participants 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.	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.
Clinical Success Rate for Draining of Pancreatic Fluid Collection (PFC)	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 3 months

Population: No participants were randomized to the LAMS plus double pigtail stent arm

Number of endoscopic interventions required for resolution of Pancreatic Fluid Collection (PFC) prior to stent removal

Outcome measures

Outcome measures
Measure	Lumen Apposing Metal Stent (LAMS) n=1 Participants 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.	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.
Number of Endoscopic Interventions Required for Resolution of PFC Prior to Stent Removal	2 number of interventions	—

SECONDARY outcome

Timeframe: 3 months

Population: No participants were randomized to the LAMS plus double pigtail stent arm

Incidence of hospital readmissions following initial endoscopic intervention and prior to resolution of Pancreatic Fluid Collection (PFC) stent removal

Outcome measures

Outcome measures
Measure	Lumen Apposing Metal Stent (LAMS) n=1 Participants 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.	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.
Incidence of Hospital Readmissions Following Initial Endoscopic Intervention and Prior to Resolution of Pancreatic Fluid Collection Stent Removal	1 event	—

SECONDARY outcome

Timeframe: 3 months

Population: No participants were randomized to the LAMS plus double pigtail stent arm

Incidence of surgical or percutaneous radiologic intervention for Pancreatic Fluid Collection (PFC) following initial endoscopy intervention

Outcome measures

Outcome measures
Measure	Lumen Apposing Metal Stent (LAMS) n=1 Participants 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.	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.
Incidence of Surgical or Percutaneous Radiologic Intervention for PFC Following Initial Endoscopy Intervention	0 event	—

SECONDARY outcome

Timeframe: 30 days

Population: No participants were randomized to the LAMS plus double pigtail stent arm

Incidence of early (\<30 days) endoscopic reintervention following initial endoscopic intervention

Outcome measures

Outcome measures
Measure	Lumen Apposing Metal Stent (LAMS) n=1 Participants 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.	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.
Incidence of Early (<30 Days) Endoscopic Reintervention	1 event	—

Adverse Events

Lumen Apposing Metal Stent (LAMS)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

LAMS Plus Double Pigtail Stent

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sharee Burkeen, Research Program Manager

Vanderbilt University Medical Center

Phone: (615) 875-7515

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place