Actively Recruiting
Timing of Necrosectomy After Endoscopic Drainage of Walled-off Pancreatic Necrosis (WON)
Led by Chinese University of Hong Kong · Updated on 2022-03-09
108
Participants Needed
9
Research Sites
230 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. The current suggested approach in international guidelines is the endoscopic step-up approach. However, recent evidence from large national cohorts support the use of direct endoscopic necrosectomy (DEN) at the time of stent placement, resulting in earlier resolution of WON and less number of necrosectomies. This study aims to investigate the clinical outcomes of the DEN versus the step-up approach for necrosectomy after endoscopic drainage of WON.
CONDITIONS
Official Title
Timing of Necrosectomy After Endoscopic Drainage of Walled-off Pancreatic Necrosis (WON)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult (≥18 years of age) patients
- Diagnosis of walled-off pancreatic necrosis (WON) based on imaging criteria per the revised Atlanta classification
- Documented history of acute pancreatitis
- Suspected or confirmed infected WON and/or symptomatic WON causing persistent pancreatic-type pain, gastric outlet or biliary obstruction, ongoing systemic illness with anorexia and weight loss, rapidly enlarging WONs, or infected WON
- WON identified on contrast-enhanced computed tomography (CECT) and deemed suitable for EUS-guided drainage
- WON with a solid component greater than 30% and/or necrosis percentage of 30% or more
You will not qualify if you...
- Previous invasive interventions for necrotising pancreatitis
- An acute flare up of chronic pancreatitis
- Recurrent acute pancreatitis
- Need for emergency laparotomy due to abdominal compartment syndrome, visceral organ perforation, bleeding, or bowel ischemia
- Contraindications to endoscopic drainage, including previous total gastrectomy, gastric bypass surgery, or prior pancreas-related surgery
- WON not adherent to the gastrointestinal wall or not accessible for endoscopic drainage
- Coagulopathy with INR greater than 1.5 and/or thrombocytopenia with platelets below 50,000/mm3
- Pregnancy
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Royal Adelaide Hospital
Adelaide, Australia
Actively Recruiting
2
The Chinese University of Hong Kong
Hong Kong, Hong Kong, 0000
Actively Recruiting
3
Medanta Institute Of Digestive & Hepatobiliary Sciences
Haryāna, India
Actively Recruiting
4
Asian Institute of Gastroenterology
Hyderabad, India
Actively Recruiting
5
Deenanath Mangeshkar Hospital & Research Centre
Pune, India
Actively Recruiting
6
Asan Medical Centre
Asan, South Korea
Actively Recruiting
7
SoonChunHyang University School of Medicine
Asan, South Korea
Actively Recruiting
8
Hospital Universitario Rio Hortega
Valladolid, Spain
Actively Recruiting
9
King Chulalongkorn Memorial Hospital
Bangkok, Thailand
Actively Recruiting
Research Team
S
Shannon Chan
CONTACT
A
Anthony Teoh
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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