Clinical trials: Walled Off Pancreatic Necrosis
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
Pancreatic Pseudocyst Infection, Pancreatic Pseudocyst
Hot AXIOS System Japan Post Market Survey
To detect information of Adverse Events and Device Malfunctions under real world medical condition in Japan.
- Conditions
- Pancreatic Pseudocyst Infection, Pancreatic Pseudocyst, Walled Off Necrosis Infection, Walled Off Necrosis
- Trial name
- NCT03797209
- Testing
- EUS-guided fistulization AXIOS
- Where
- 40 sites in Japan
- Volunteers
- 120 people
- Sponsor
- Boston Scientific Japan K.K.
Acute Necrotizing Pancreatitis, Walled Off Necrosis
Plastic Stents vs. NAGI Bi-flanged Metal Stent for Endoscopic Ultrasound Guided Drainage of Walled-off Necrosis
Introduction: Walled off necrosis (WON) is defined as a well circumscribed pancreatic and/or peri pancreatic necrosis containing a variable amount of necrotic tissue.
- Trial name
- NCT04479228
- Testing
- Endosonography guided transmural drainage
- Volunteers
- 80 people
- Sponsor
- Asian Institute of Gastroenterology, India
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
Pancreatic Necrosis, Pancreatitis, Acute Necrotizing
Endoscopic Step-up Approach vs Aggressive Debridement of Large Pancreatic Walled-off Necrosis
The goal of this clinical trial is to compare a conventional endoscopic step-up approach with an accelerated treatment algorithm using direct endoscopic necrosectomy in patients with acute necrotizing pancreatitis and walled of…
- Trial name
- NCT05601687
- Testing
- Direct Endoscopic Necrosectomy, Step-up Approach
- Where
- Denmark
- Volunteers
- 25 people
- Sponsor
- Copenhagen University Hospital, Hvidovre
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
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 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
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
Acute Necrotizing Pancreatitis
Tracking ENcapsulation of Pancreatic Collections in Acute Necrotizing Pancreatitis
The goal of this study is to investigate the encapsulation of fluid collections in patients with ANP using serial MRI. The main questions it aims to answer are: Evaluating the timing of encapsulation of necrotic fluid collection…
- Trial name
- NCT05716633
- Testing
- MRI
- Where
- India
- Volunteers
- 100 people
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
Pancreas Necrosis, Pancreatic Collection
EUS-guided Transmural Drainage of Walled-off Pancreatic Necrosis: Plastic vs Metallic Protesis.
Randomized multicenter study comparing plastic stents and self-expanding metallic stents in the eus-guided transmural drainage of walled-off pancreatic necrosis.
- Trial name
- PROMETHEUS (NCT03100578)
- Testing
- WOPN TRANSMURAL DRAINAGE: PLASTIC STENT, WOPN TRANSMURAL DRAINAGE: METALLIC STENT
- Where
- 8 sites in Spain
- Volunteers
- 99 people
- Sponsor
- Hospital Universitari de Bellvitge
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 Pancreatic Necrosis, Acute Pancreatitis
EndoRotor DEN (Direct Endoscopic Necrosectomy)Trial
A prospective, single arm, open label, multi-center, trial to evaluate the safety and effectiveness of the Interscope EndoRotor® Resection System in subjects requiring direct endoscopic necrosectomy (DEN) with walled off…
- Conditions
- Acute Pancreatic Necrosis, Acute Pancreatitis, Necrotizing Pancreatitis
- Trial name
- NCT03694210
- Testing
- EndoRotor Therapy
- Where
- 10 sites in United States, Germany and 1 more
- Volunteers
- 30 people
- Sponsor
- Interscope, Inc.
Acute Pancreatitis Necrotizing
Impact of Transmural Plastic Stent on Recurrence of Pancreatic Fluid Collection After Metal Stent Removal in Disconnected Pancreatic Duct
Walled of necrosis (WON) is severe local complication of acute necrotizing pancreatitis. Disconnected pancreatic duct syndrome(DPDS) is commonly seen (50-60%) after necrotizing pancreatitis and has long term implication like…
- Trial name
- NCT03436043
- Testing
- Transmural Plastic stenting
- Where
- India
- Volunteers
- 90 people
- Sponsor
- Asian Institute of Gastroenterology, India
Pancreatitis, Acute Necrotizing
Immediate vs. On-demand Endoscopic Necrosectomy in Infected Walled-off Pancreatic Necrosis
Acute pancreatitis is one of the most common diagnoses made in gastroenterology wards worldwide which causes a great deal of pain and expense along with fatal complications.
- Trial name
- NCT05530772
- Testing
- Endoscopic necrosectomy
- Where
- Iran
- Volunteers
- 50 people
- Sponsor
- University of Tehran
Walled Off Necrosis, Pancreatitis
Encapsulation-oriented vs. Timing-oriented Strategies for Necrotizing Pancreatitis
This multicenter, randomized controlled trial (WONDER-03 study) investigates the optimal timing for endoscopic ultrasound (EUS)-guided drainage in patients with necrotizing pancreatitis.
- Conditions
- Walled Off Necrosis, Pancreatitis, Acute Necrotic Collection, Necrotizing Pancreatitis
- Trial name
- WONDER-03 (NCT07106346)
- Testing
- The timing of endoscopic intervention for necrotizing pancreatitis is determined based on the degree of encapsulation, EUS-guided drainage based on the interval from the onset of acute pancreatitis
- Where
- 36 sites in Japan
- Volunteers
- 224 people
- Sponsor
- Tokyo University
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 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
Pancreatitis, Acute Necrotizing, Walled Off Necrosis
Lumen-apposing Metal Stent With or Without Coaxial Plastic Stent for Treatment of Walled-off Pancreatic Necrosis
A prospective randomized cohort study to compare whether the placement of a double-pigtail plastic stent (DPS) within a lumen-apposing metal stent (LAMS) may improve the efficacy and safety of endoscopic ultrasound guided…
- Trial name
- NCT03923686
- Testing
- EUS-guided drainage using LAMS with DPS, EUS-guided drainage using LAMS alone
- Where
- Czechia
- Volunteers
- 67 people
- Sponsor
- Palacky University
Acute Pancreatitis
Late Phase Acute Pancreatitis: a Tailored Step-up Approach
Several interventional and surgical procedures are available to treat moderate-to-critical acute pancreatitis (AP) in its late phase.
- Trial name
- TSA (NCT04870268)
- Testing
- percutaneous drainage, endoscopic approach, surgical internal derivation of WON
- Volunteers
- 47 people
- Sponsor
- University of Pisa