Clinical trials: Pancreatic Stent
Pancreatic Carcinoma
Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer
The purpose of this study is to demonstrate that preoperative biliary drainage using self-expanding metal stents (SEMS) does not negatively impact overall surgical outcomes in patients undergoing pancreaticoduodenectomy for…
- Trial name
- NCT01774019
- Testing
- WallFlex™ Biliary RX Fully Covered/Uncovered Stent System
- Where
- 11 sites in United States, Australia and 7 more
- Volunteers
- 284 people
- Sponsor
- Boston Scientific Corporation
Pancreatic Cancer
Plastic vs. Covered Metal vs. Uncovered Metal Biliary Stents for the Management of Malignant Biliary Obstruction
This is a single center, randomized, unblinded study to compare the rate of occlusion of plastic, uncovered metal, or fully covered metal biliary stents in patient's with surgically resectable disease or those undergoing…
- Trial name
- NCT01038713
- Testing
- Biliary stent placement
- Where
- United States
- Volunteers
- 94 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
Surgical Site Infection, Pancreatic Neoplasms
Comparison Between Wound Vacuum Dressing and Standard Closure to Reduce Rates of Surgical Site Infections
Pancreaticoduodenectomy is associated with high perioperative morbidity, with surgical site infection (SSIs) being one of the most common complications.
- Conditions
- Surgical Site Infection, Pancreatic Neoplasms, Pancreatic Cancer, Chemotherapy Effects
- Trial name
- NCT03021668
- Testing
- Prevena Peel & Place Dressing, Standard Closure of the Surgical Incision
- Where
- United States
- Volunteers
- 124 people
- Sponsor
- Johns Hopkins University
Walled Off Pancreatic Necrosis
AXIOS Lumen Apposing Metal Stent for Walled Off Necrosis Drainage IDE Study
To demonstrate safety and effectiveness of lumen-apposing metal stents for resolution of walled off pancreatic necrosis (WONs) in patients with WONs with solid component >30%.
- Trial name
- NCT03525808
- Testing
- AXIOS
- Where
- 5 sites in United States
- Volunteers
- 40 people
- Sponsor
- Boston Scientific Corporation
Pancreatic Cancer, Unresectable Biliary-pancreatic Malignancies
Endoscopic Biliary Co-axial Stent Placement Plus/Minus Use of Radiofrequency Ablation (RFA) for Clearance of Occluded Self Expandable Metal Stents (SEMS) in Patients With Distal Biliary Obstruction From Unresectable Biliary-pancreatic Malignancies
The purpose of this study is to compare the effects good and/or bad of combining radiofrequency ablation with placement of a second stent, versus a second stent alone.
- Trial name
- NCT02340728
- Testing
- ERCP with SEMS plus radiofrequency ablation, ERCP with SEMS alone (standard of care)
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Pancreatic Pseudocyst
A Study to Evaluate the Effectiveness and Safety of EUS-guided Transluminal Drainage With 'Niti-S SPAXUS Stent'
The purpose of this study is to evaluate the safety and effectiveness of endoscopic ultrasound (EUS)-guided transluminal drainage with 'Niti-S SPAXUS Stent' for the treatment of pancreatic pseudocyst.
- Trial name
- NCT02730663
- Testing
- Niti-S SPAXUS Stent
- Where
- 6 sites in South Korea
- Volunteers
- 36 people
- Sponsor
- Taewoong Medical Co., Ltd.
Pancreatic Fistula
Closed Suction Drainage and Natural Drainage of the Pancreatic Duct in Pancreaticojejunostomy
Pancreaticojejunal anastomosis leakage is a major complication after pancreatoduodenectomy and various technical methods have been examined to improve the situation.However, none of methods have been successful at improving…
- Trial name
- NCT00679952
- Testing
- closed suction drainage of pancreatic duct, natural drainage of pancreatic duct
- Where
- South Korea
- Volunteers
- 168 people
- Sponsor
- Seoul National University Hospital
Distal Bile Duct Obstruction
Covered vs Uncovered Metal Stents for Palliative Biliary Decompression in Inoperable Malignant Distal Bile Duct Obstruction
The purpose of this study is to compare the rate of long-term stent failure, defined as need for repeat biliary intervention following placement of C-SEMS vs U-SEMS for palliation of inoperable malignant distal bile duct…
- Trial name
- NCT01905384
- Testing
- Covered Self-expanding metal biliary stents (C-SEMS), Uncovered Self-expanding metal biliary stents (U-SEMS)
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Vanderbilt University Medical Center
Pancreatic Pseudocyst(s)
AXIOS Stent & Delivery System Study
The Xlumena AXIOS Stent and Delivery System is an investigational device in the USA, and this study is being conducted under an Investigational Device Exemption (IDE) granted by the US Food and Drug Administration (FDA).
- Trial name
- NCT01419769
- Testing
- AXIOS Stent & Delivery System
- Where
- 7 sites in United States, Spain
- Volunteers
- 30 people
- Sponsor
- Xlumena, Inc.
Biliary Tract Neoplasms, Pancreatic Neoplasms
Malignant Obstruction ZILVER Against Routine Therapy (MOZART I)
This study compares the 6 mm nitinol Zilver biliary endoprostheses and the 10 mm nitinol Zilver biliary endoprostheses to the 10 mm Wallstent in appropriate patients in need of palliative treatment of malignant obstructive…
- Conditions
- Biliary Tract Neoplasms, Pancreatic Neoplasms, Jaundice, Obstructive
- Trial name
- NCT00196105
- Testing
- 6 mm Nitinol Zilver Stent, 10 mm Nitinol Zilver Stent, 10 mm Stainless Steel Wallstent
- Where
- United States
- Volunteers
- 241 people
- Sponsor
- Cook Group Incorporated
Common Bile Duct Stricture
Covered Metallic Stents for First-Line Treatment of Benign Bile Duct Strictures
The current standard of care for benign bile duct strictures involves placement of multiple plastic stents under endoscopic and fluoroscopic guidance to progressively dilate or stretch it open.
- Trial name
- NCT01221311
- Testing
- Fully covered Metallic Stent, Plastic Stent
- Where
- 8 sites in United States, United Kingdom
- Volunteers
- 112 people
- Sponsor
- Medical University of South Carolina
Pancreatic Pseudocysts
Evaluation of Pancreatic Pseudocyst Drainage With a Metal Stent
The purpose of this study is to study the evaluation of the effectiveness of endoscopic Pancreatic Pseudocyst drainage using a metal stent.
- Trial name
- NCT01239056
- Testing
- Endoscopy
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- University of Florida
Pancreatic Cancer
Pre-operative Biliary SEMS RCT During Neoadjuvant Therapy
The purpose of this study is to demonstrate non-inferiority of Fully Covered biliary SEMS to Uncovered biliary SEMS in biliary drainage for the pre-operative management of biliary obstructive symptoms caused by pancreatic cancer…
- Trial name
- NCT02238847
- Testing
- WallFlex™ Biliary RX Fully Covered/Uncovered Stent System
- Where
- 9 sites in United States, Belgium and 4 more
- Volunteers
- 119 people
- Sponsor
- Boston Scientific Corporation
Pancreatic Pseudocyst
Lumen Apposing Metal Stents vs Lumen Apposing Metal Stent Plus Double Pigtail Stent for Endoscopic Drainage
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…
- Trial name
- Axios (NCT03049215)
- Testing
- Lumen Apposing Metal Stent (LAMS), LAMS plus double pigtail stent
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Vanderbilt University Medical Center
Pancreatic Necrosis
Study of a Lumen- Apposing, Covered, Self-Expanding Metal Stent (Axios™) Versus Multiple Double Pigtail Stents
The present study aims to compare the clinical efficacy and cost effectiveness of the AXIOS™ stent versus the "conventional" approach using double pigtail plastic stents in the treatment of patients with walled-off pancreatic…
- Trial name
- NCT02673541
- Testing
- AXIOS™ stent, Double Pigtail Stents
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
Pancreatic Cancer
SEMS Placement Before Surgery in Unblocking Bile Duct in Patients With Periampullary Pancreatic Cancer With Severe Obstructive Jaundice
This trial studies the side effects of self expanding metal stent (SEMS) placement before surgery in unblocking the bile duct in patients with periampullary pancreatic cancer with severe obstructive jaundice.
- Trial name
- NCT03820544
- Testing
- Endoscopic Retrograde Cholangiopancreatography, Standard of care
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Chronic Pancreatitis
WallFlex Pancreatic Metal Stent for Pancreatic Duct Strictures
To prospectively document the performance of a FCSEMS for treatment of pancreatic duct strictures in patients with painful chronic pancreatitis.
- Trial name
- NCT02802020
- Testing
- Pancreatic fully-covered self-expanding metal stent (FCSEMS)
- Where
- 11 sites in United States, Belgium and 4 more
- Volunteers
- 67 people
- Sponsor
- Boston Scientific Corporation
Pancreatic Pseudocyst(s)
AXIOS Stent With Electrocautery Enhanced Delivery System
The purpose of this study is to demonstrate the safety and effectiveness of the AXIOS Stent with Electrocautery Enhanced Delivery System for endoscopic transenteric drainage of pancreatic pseudocysts.
- Trial name
- NCT02146352
- Testing
- AXIOS Stent with Electrocautery Enhanced Delivery System
- Where
- 8 sites in United States
- Volunteers
- 30 people
- Sponsor
- Xlumena, Inc.