Clinical trials: Walled-off Necrosis
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 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
Pancreatic Necrosis, Acute Pancreatitis
Necrosectomy With Cryotechnology for Accelerated Removal
Pancreatic necrosis is a serious complication of acute pancreatitis. Pancreatic necrosis involves the irreversible death of pancreatic tissue, which can lead to severe health issues, including infections and an increased risk of…
- Conditions
- Pancreatic Necrosis, Acute Pancreatitis, Acute Pancreatic Necrosis, Necrosis
- Trial name
- NECTAR (NCT06553651)
- Testing
- Cryotechnology Necrosectomy Procedure
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Christopher C. Thompson, MD, MSc
Walled Off Necrosis
To Evaluate Early (2-Week) vs. Standard (4-Week) Metal Stent Removal Following Endoscopic Ultrasound Guided WON Drainage
In adults with walled-off pancreatic necrosis (WON) undergoing endoscopic ultrasound (EUS)-guided transluminal necrosectomy, does early removal of the lumen-apposing metal stent (LAMS) (at 2 weeks or immediately after the last…
- Trial name
- STEP1 (NCT07307248)
- Testing
- Standard LAMS Removal with Double-Pigtail Plastic Stent, Standard LAMS Removal without DPT
- Where
- India
- Volunteers
- 408 people
- Sponsor
- Asian Institute of Gastroenterology, India
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
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
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 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
Acute Pancreatitis, Pancreatic Fluid Collection
Management and Outcomes of Local Complications of Acute Pancreatitis and Postoperative Pancreatic Fistula
This multicenter prospective observational registry will evaluate the clinical characteristics and treatment outcomes of adults with local complications of acute pancreatitis or postoperative pancreatic fistula.
- Conditions
- Acute Pancreatitis, Pancreatic Fluid Collection, Postoperative Pancreatic Fistula
- Trial name
- WONDERFUL (NCT07862088)
- Testing
- Routine Clinical Management of Local Complications
- Where
- 12 sites in Japan
- Volunteers
- 5,000 people
- Sponsor
- Tokyo University
Necrotizing Pancreatitis
Endoscopic Large Caliber Drainage vs. Complete Necrosectomy for Treatment of Walled-off Pancreatic Necrosis
The purpose of this study is to determine optimal treatment strategies for symptomatic walled-off pancreatic necrosis( WON).
- Trial name
- NCT02564965
- Testing
- Double Pigtail Plastic Stent, AXIOS Metal Stent
- Sponsor
- Mayo Clinic
Walled-off Necrosis
A Comparison Between Lumen-apposing Metal Stent and Double-pigtail Plastic Stents for Treatment of Walled-off Necrosis
Walled-off necrosis (WON) is defined as an encapsulated collection of solid and liquid necrotic material that is usually formed 4 weeks after an episode of acute necrotizing pancreatitis.
- Trial name
- NCT04876235
- Testing
- endoscopic ultrasound, lumen-apposing metal stent, double-pigtail plastic stents
- Where
- China
- Volunteers
- 50 people
- Sponsor
- First People's Hospital of Hangzhou
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.
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
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
Pancreatitis, Walled Off Pancreatic Necrosis
Bedside Monitoring of Microenvironmental Changes in Infected Pancreatic Collections
This pilot clinical study aims to assess the feasibility and clinical relevance of bedside monitoring of microenvironmental conditions within infected walled-off pancreatic necrosis (WOPN).
- Trial name
- WOPN-MONITOR (NCT07131917)
- Testing
- Miniaturized Intracavitary Monitoring Probe
- Where
- Czechia
- Volunteers
- 20 people
- Sponsor
- Martin Harazim
Walled-off Necrosis
Comparing Fully Covered, Self Expanding Metal Stent (FCSEMS) and Plastic Stents for EUS- Guided Drainage of WON
This is a multi-center, single-blinded, randomized trial comparing AXIOS FCSEMS (Fully Covered Self Expanding Metal Stent) and plastic stents for EUS (Endoscopic Ultrasound)-guided management of infected and/or symptomatic WON…
- Trial name
- WON (NCT02718092)
- Testing
- Plastic Stent, Axios Fully Covered Self Expanding Metal Stent
- Sponsor
- Indiana University
Pancreatic Necrosis, Pancreatitis
Surgical vs Endoscopic Resection of Walled Off Pancreatic Necrosis Using the Powered Endoscopic Debridement System
Goal: The goal of this clinical trial is to compare the effectiveness and safety of two different but highly effective treatment approaches for walled-off necrosis (WON) resulting from severe acute pancreatitis.
- Trial name
- SERPENT (NCT06691919)
- Testing
- Direct Endoscopic Necrosectomy with Powered Endoscopic Debridement, Transgastric Surgical Necrosectomy
- Sponsor
- Stanford University
Acute Pancreatitis, Necrotizing Pancreatitis
Timing of Transmural Stent Removal in Necrotizing Pancreatitis
Although metal stents have been widely used in the endoscopic step-up approach for necrotizing pancreatitis, the exact timing of transmural stent removal has not been well studied.
- Conditions
- Acute Pancreatitis, Necrotizing Pancreatitis, Walled-Off Necrosis
- Trial name
- TTSRNP (NCT04963868)
- Testing
- Stent removed by the novel strategy, Stent removed by the conventional strategy
- Where
- China
- Volunteers
- 156 people
- Sponsor
- The First Affiliated Hospital of Nanchang University
Pancreatic Walled-off Necrosis
The Effect of Proton Pump Inhibitors(PPIs) on Endoscopic Treatment of Walled-off Necrosis (WON)
In this multicenter, randomized controlled trial, patients with pancreatic walled-off necrosis (WON) based on inclusion and exclusion criteria will be randomly assigned in a 1:1 ratio to either receive intravenous infusion or…
- Trial name
- NCT07488299
- Testing
- Proton Pump Inhibitors
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Qilu Hospital of Shandong University
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