Safety and Efficacy of the New 20 mm Lumen Apposing Metal Stent (Lams) for Endoscopic Treatment of Pancreatic and Peripancreatic Fluid Collections
Primary Purpose
Pancreatic Diseases
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Hot Axios stent
Sponsored by
About this trial
This is an interventional other trial for Pancreatic Diseases
Eligibility Criteria
Inclusion Criteria:
- Consecutive patients who underwent EUS-guided 20 mm Hot Axios stent placement for PFCs were included.
Exclusion Criteria:
- No exclusion criteria
Sites / Locations
- Humanitas Research Hospital
Outcomes
Primary Outcome Measures
The investigators will evaluate the use of the new 20 mm Hot Axios in endoscopic transmural drainage through the reduction pof the bilirubin's value
Secondary Outcome Measures
The investigators will assess the rate/severity of adverse events (AEs) (ASGE lexicon).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03578770
Brief Title
Safety and Efficacy of the New 20 mm Lumen Apposing Metal Stent (Lams) for Endoscopic Treatment of Pancreatic and Peripancreatic Fluid Collections
Official Title
Safety and Efficacy of the New 20 mm Lumen Apposing Metal Stent (Lams) for Endoscopic Treatment of Pancreatic and Peripancreatic Fluid Collections: a Large, International, Multicenter Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Clinico Humanitas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pancreatic fluid collections (PFC) can occur as a complication of acute and chronic pancreatitis. PFC include pancreatic pseudocysts (PP) and walled-off necrosis (WON).
The majorities of WON are asymptomatic and will resolve spontaneously. Endoscopic ultrasound (EUS)-guided drainage has become the preferred treatment in the management of symptomatic PFC, with significant advantages compared with surgical and percutaneous drainage. Successful endoscopic management of the pancreatic fluid collections depends on the type of PFC. Studies have shown that endoscopic drainage of PP is greater than 90%, while success for WON is at best between 50-65%. Differences in treatment outcome are attributed to the viscosity and debris content of the PFC. Traditionally, the EUS-guided drainage has been performed with placement of multiple plastic stents or fully covered self-expanding metal stent.
Recently, lumen-apposing metal stents (LAMS) have been developed. LAMS have been utilized for the access and drainage of pancreatic fluid collections (PFCs). To date, a variety of LAMS sizes have been commercially available and widely used. Studies have shown high technical success (89-100%) and high clinical success rate (93-100%). The larger diameter of LAMS facilitates better drainage of PFC contents when compared to the small caliber of plastic stents and allows necrosectomy in repeated sessions without the need for stent replacement.
A new LAMS with a larger (20mm) lumen diameter (the Hot Axios, Boston Scientific, Natick MA, USA) was released on the market, with the idea that a larger diameter would allow a faster drainage of PFCs and facilitate endoscopic necrosectomy. This is currently the largest diameter LAMS available.
Further studies are needed to determine the ideal size for a LAMS going forward to achieve maximal clinical benefit with minimal patient risk.
Aim of the investigator's study is to evaluate the safety and efficacy of the new 20 mm Hot Axios stent placement for EUS-guided transmural drainage of pancreatic fluid collections.
Detailed Description
Pancreatic fluid collections (PFC) can occur as a complication of acute and chronic pancreatitis. PFC include pancreatic pseudocysts (PP) and walled-off necrosis (WON).
The majorities of WON are asymptomatic and will resolve spontaneously. Endoscopic ultrasound (EUS)-guided drainage has become the preferred treatment in the management of symptomatic PFC, with significant advantages compared with surgical and percutaneous drainage. Successful endoscopic management of the pancreatic fluid collections depends on the type of PFC. Studies have shown that endoscopic drainage of PP is greater than 90%, while success for WON is at best between 50-65%. Differences in treatment outcome are attributed to the viscosity and debris content of the PFC. Traditionally, the EUS-guided drainage has been performed with placement of multiple plastic stents or fully covered self-expanding metal stent.
Recently, lumen-apposing metal stents (LAMS) have been developed. LAMS have been utilized for the access and drainage of pancreatic fluid collections (PFCs). To date, a variety of LAMS sizes have been commercially available and widely used. Studies have shown high technical success (89-100%) and high clinical success rate (93-100%). The larger diameter of LAMS facilitates better drainage of PFC contents when compared to the small caliber of plastic stents and allows necrosectomy in repeated sessions without the need for stent replacement.
A new LAMS with a larger (20mm) lumen diameter (the Hot Axios, Boston Scientific, Natick MA, USA) was released on the market, with the idea that a larger diameter would allow a faster drainage of PFCs and facilitate endoscopic necrosectomy. This is currently the largest diameter LAMS available.
Further studies are needed to determine the ideal size for a LAMS going forward to achieve maximal clinical benefit with minimal patient risk.
Aim of the investigator's study is to evaluate the safety and efficacy of the new 20 mm Hot Axios stent placement for EUS-guided transmural drainage of pancreatic fluid collections.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Diseases
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Feasibility device
Masking
None (Open Label)
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Hot Axios stent
Intervention Description
Hot Axios stent
Primary Outcome Measure Information:
Title
The investigators will evaluate the use of the new 20 mm Hot Axios in endoscopic transmural drainage through the reduction pof the bilirubin's value
Time Frame
24 months
Secondary Outcome Measure Information:
Title
The investigators will assess the rate/severity of adverse events (AEs) (ASGE lexicon).
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Consecutive patients who underwent EUS-guided 20 mm Hot Axios stent placement for PFCs were included.
Exclusion Criteria:
No exclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Repici Alessandro, MD
Organizational Affiliation
Humanitas Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Humanitas Research Hospital
City
Milano
ZIP/Postal Code
20089
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety and Efficacy of the New 20 mm Lumen Apposing Metal Stent (Lams) for Endoscopic Treatment of Pancreatic and Peripancreatic Fluid Collections
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