Clinical trials: Walled-Off Pancreatic Necrosis
Pancreatic Pseudocyst
Endoscopic Ultrasound-guided Drainage of Walled Off Necrosis (WON)
The purpose of this study is to compare the effect of lumen-apposing metal stent (LAMS) and double pigtail plastic stents (DPPSs) on the drainage of pancreatic walled-off necrosis (WON), mainly to observe the efficacy and safety…
- Trial name
- NCT03027895
- Testing
- Lumen-apposing metal stent (LAMS), Double pigtail plastic stent (DPPS)
- Volunteers
- 256 people
- Sponsor
- Yiqi Du
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
Acute Pancreatitis, Necrosis; Pancreas, Acute (Infectious)
Conventional Endoscopic Techniques Versus EndoRotor® System for Necrosectomy of Walled of Necrosis
In acute pancreatitis, approximately 20% of the cases result in severe necrotizing pancreatitis which is associated with significant morbidity and mortality.
- Trial name
- RESOlVE (NCT04814693)
- Testing
- EndoRotor® System (Interscope, Inc., Northbridge, MA USA),, Conventional endoscopic devices (according to standards of care)
- Where
- 12 sites in United States, Denmark and 4 more
- Volunteers
- 60 people
- Sponsor
- Erasmus Medical Center
Pancreatic Necrosis
Timing of Necrosectomy After Endoscopic Drainage of Walled-off Pancreatic Necrosis (WON)
Walled-off pancreatic necrosis (WON) is associated with a mortality of 20-30%. The current evidence supports a minimally invasive drainage approach to infected WON.
- Trial name
- NCT05252897
- Testing
- Endoscopic necrosectomy with step up approach, Endoscopic necrosectomy with direct approach
- Where
- 9 sites in Australia, Hong Kong and 4 more
- Volunteers
- 108 people
- Sponsor
- Chinese University of Hong Kong
Necrotizing Pancreatitis, Walled Off Necrosis
Pancreatic Duct Stent for Acute Necrotizing Pancreatitis
The research design is a randomized prospective clinical study comparing the incidence of Walled Off Necrosis (WON) in patients with acute necrotizing pancreatitis.
- Trial name
- NCT03115918
- Testing
- Pancreatic Duct Stent Placement, No Pancreatic Duct Stent Placement
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- AdventHealth
Walled Off Pancreatic Necrosis (WON)
Rad Predictors for WON
This is a retrospective chart review study examining 1) demographic data such as age, sex, etiology of pancreatitis 2) clinical data including radiological characteristics of walled off pancreatic necrosis, walled off necrosis…
- Trial name
- NCT03801070
- Testing
- endoscopic drainage of walled off pancreatic necrosis
- Where
- United States
- Volunteers
- 104 people
- Sponsor
- Washington University School of Medicine
Pancreatitis,Acute Necrotizing
Lumen Apposing Metal Stents vs Double Pigtail Stents
While the majority of patients with acute pancreatitis suffer a mild and uncomplicated course of disease, up to 20% develop a more severe course with development of pancreatic and/or peripancreatic necroses.
- Trial name
- NCT04057846
- Testing
- EUS guided transgastric drainage
- Where
- Denmark
- Volunteers
- 42 people
- Sponsor
- John Gasdal Karstensen
ENDOSCOPIC ULTRASONOGRAPHY
COMPARISON OF OUTCOMES OF BI-FLANGED METAL STENT ALONE VERSUS BI-FLANGED METAL STENT WITH CO-AXIAL PLASTIC STENT FOR DRAINAGE OF WALLED-OFF PANCREATIC NECROSIS - A PROSPECTIVE RANDOMISED CONTROLLED STUDY.
Endoscopic ultrasound guided drainage of WON with metal stent is the mainstay of WON management. But there are few complications related to BFMS , like bleeding due to vessel erosion, stent clogging , stent migration .
- Trial name
- BFMSP (NCT05632900)
- Testing
- Endoscopic ultrasound guided drainage of walled off pancreatic necrosis
- Where
- India
- Volunteers
- 76 people
- Sponsor
- Asian Institute of Gastroenterology, India
Infected Pancreatic Necrosis, Acute Pancreatic Fluid Collection
Comparison of FCSEMS and Plastic Stents
The research design is a randomized prospective clinical trial comparing Endoscopic ultrasound (EUS) guided drainage of WON using FCSEMS and plastic stents.
- Conditions
- Infected Pancreatic Necrosis, Acute Pancreatic Fluid Collection, Pancreatic and Peripancreatic Necrosis, Pancreatic Collection
- Trial name
- WON-MVP (NCT02685865)
- Testing
- FCSEM Stent, Plastic Stent
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- AdventHealth
Pancreatic Pseudocyst and Walled-off Necrosis
AXIOS CHINA (E7148)
To study the safety and effectiveness of the AXIOS Stent with Electrocautery Enhanced Delivery System for endoscopic trans enteric drainage of pancreatic pseudocyst and walled-off necrosis in Chinese population, to support the…
- Trial name
- NCT03808272
- Testing
- HOT AXIOS Stent and Electrocautery- Enhanced Delivery System
- Where
- China
- Volunteers
- 31 people
- Sponsor
- Boston Scientific Corporation
Acute Necrotizing Pancreatitis
Effectiveness of Endorotor PED® System Versus Conventional Endoscopic Techniques for the Management of Walled-off Pancreatic Necrosis in Acute Necrotizing Pancreatitis: Randomized Single-blinded Controlled Superiority Trial and Cost-utility Analysis
This is a national single-blinded prospective multicenter randomized (1:1) controlled trial, with two parallel arms, using a PROBE methodology, including patients with complicated acute necrotizing pancreatitis who require DEN of…
- Trial name
- ROTONEC (NCT07253350)
- Testing
- Endorotor Group, Conventional group
- Where
- France
- Volunteers
- 64 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Pancreatic Fluid Collection, Walled-off Necrosis
Immediate Necrosectomy vs. Step-up Approach for Walled-off Necrosis
Walled-off necrosis (WON) is a pancreatic fluid collection, which contains necrotic tissue after four weeks of the onset of acute pancreatitis.
- Conditions
- Pancreatic Fluid Collection, Walled-off Necrosis, Pancreatitis, Acute Necrotizing, Pancreatic Pseudocyst
- Trial name
- WONDER-01 (NCT05451901)
- Testing
- Immediate necrosectomy, Step-up approach
- Where
- 21 sites in Japan
- Volunteers
- 70 people
- Sponsor
- Tokyo University