Pancreatic PseudocystAxiosNCT03049215
Lumen Apposing Metal Stents vs Lumen Apposing Metal Stent Plus Double Pigtail Stent for Endoscopic Drainage
A study testing Lumen Apposing Metal Stent (LAMS) and LAMS plus double pigtail stent in people with Pancreatic Pseudocyst, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Pseudocyst
- What is being tested?
- Lumen Apposing Metal Stent (LAMS) and LAMS plus double pigtail stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unwilling/unable to give informed consent
- Patients with PFCs consisting of < 30% solid component as assessed at the time of EUS
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Lumen Apposing Metal Stents vs Lumen Apposing Metal Stent Plus Double Pigtail Stent for Endoscopic Drainage of Pancreatic Fluid Collections: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Pancreatic Pseudocyst
- Being tested
- Lumen Apposing Metal Stent (LAMS), LAMS plus double pigtail stent
- Medical subject headings
- Pancreatic Pseudocyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumen Apposing Metal Stent (LAMS)Device
Also called Axios 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.
LAMS plus double pigtail stentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: LAMS plus double pigtail stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days following placement of stent
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 3 months
Incidence of Early (<30 Days) Endoscopic Reintervention
Incidence of early (<30 days) endoscopic reintervention following initial endoscopic intervention
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start6 Nov 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Why it stopped: Study terminated due to low/difficulty enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic PseudocystStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Yachimski, Vanderbilt University Medical Center
- Investigators
- Patrick Yachimski, MD, MPH, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03049215
- Sponsor's protocol ID
- 170247
- Acronym
- Axios
- Status last verified
- Aug 2021
- First submitted
- 7 Feb 2017
- Last updated
- 19 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumen Apposing Metal Stents vs Lumen Apposing Metal Stent Plus Double Pigtail Stent for Endoscopic Drainage of Pancreatic Fluid Collections: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03049215
- Acronym / sponsor ID
- Axios / 170247
- Conditions
- Pancreatic Pseudocyst
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to low/difficulty enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 9 Feb 2017 (estimated)
- Results
- Posted 19 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Lumen Apposing Metal Stent (LAMS) | Active comparator | Device: 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. |
| LAMS plus double pigtail stent | Active comparator | Device: LAMS plus double pigtail stentSubjects 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Unwilling/unable to give informed consent
- Patients with PFCs consisting of < 30% solid component as assessed at the time of EUS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumen Apposing Metal Stent (LAMS)Also: Axios StentThe 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. | Device | Lumen Apposing Metal Stent (LAMS) |
| LAMS plus double pigtail stentThe 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. | Device | LAMS plus double pigtail stent |
Primary outcome
Decrease in Pancreatic Fluid Collection (PFC)
Time frame: 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
5 secondary outcomes
Clinical Success Rate for Draining of Pancreatic Fluid Collection (PFC)
Time frame: 3 months
Number of Endoscopic Interventions Required for Resolution of PFC Prior to Stent Removal
Time frame: 3 months
Incidence of Hospital Readmissions Following Initial Endoscopic Intervention and Prior to Resolution of Pancreatic Fluid Collection Stent Removal
Time frame: 3 months
Incidence of Surgical or Percutaneous Radiologic Intervention for PFC Following Initial Endoscopy Intervention
Time frame: 3 months
Incidence of Early (<30 Days) Endoscopic Reintervention
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Yachimski, MD, MPH principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumen Apposing Metal Stent (LAMS) and LAMS plus double pigtail stent in people with Pancreatic Pseudocyst, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in Pancreatic Fluid Collection (PFC) (time frame: 30 days following placement of stent). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021.