Clinical trials: Walled Off Necrosis
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
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
Walled Off Pancreatic Necrosis, Acute Pancreatitis (AP)
Nasojejunal Feeding Versus Oral Feeding Following Endoscopic Drainage of Walled Off Pancreatic Necrosis
The goal of this randomized control trial is to assess whether nasojejunal feed is better than oral nutrition in patients who are undergoing endoscopic cystogastrostomy of walled off necrosis following acute pancreatitis.
- Conditions
- Walled Off Pancreatic Necrosis, Acute Pancreatitis (AP), Endoscopic Ultrasound-Guided Drainage
- Trial name
- NCT07395778
- Testing
- endoscopic ultrasonography guided cystogastrostomy
- Where
- India
- Volunteers
- 50 people
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
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
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 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 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 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
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
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
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
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, 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, 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, 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 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, 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
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.
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