Status:
RECRUITING
Timing of Necrosectomy After Endoscopic Drainage of Walled-off Pancreatic Necrosis (WON)
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Pancreatic Necrosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 i...
Detailed Description
INTRODUCTION Acute pancreatitis is one of the most common gastrointestinal diseases requiring emergency admissions to the hospital. 10-20% of these patients develop pancreatic necrosis and subsequent ...
Eligibility Criteria
Inclusion
- Adult (≥18 years of age) patients
- Diagnosis of walled-off pancreatic necrosis (WON) based on imaging criteria based on the revised Atlanta classification5
- Documented history of acute pancreatitis
- Suspected or confirmed infected WON and/or symptomatic WON causing (i) persistent pancreatic-type pain, and/or ii) gastric outlet or biliary obstruction, and/or (iii) ongoing systemic illness, anorexia, and weight loss, and/or (iv) rapidly enlarging WONs, and/or (v) infected WON\*
- WON identified at contrast-enhanced computed tomography (CECT) and deemed amenable for EUS-guided drainage
- WON with a solid component \>30% and/ or percentage of necrosis \>= 30%
Exclusion
- Previous invasive interventions for necrotising pancreatitis
- An acute flare up of chronic pancreatitis
- Recurrent acute pancreatitis
- Indicated for emergency laparotomy (i.e. abdominal compartment syndrome, perforation of a visceral organ, bleeding and bowel ischaemia)
- Contraindications to endoscopic drainage: previous total gastrectomy, gastric bypass surgery, prior surgery for pancreas-related diseases
- WON not adherent to the GI wall or not accessible for endoscopic drainage
- Coagulopathy (INR \>1.5), and/or thrombocytopenia (platelets \<50,000/mm3)
- Pregnancy
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT05252897
Start Date
February 1 2022
End Date
June 30 2026
Last Update
March 9 2022
Active Locations (9)
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1
Royal Adelaide Hospital
Adelaide, Australia
2
The Chinese University of Hong Kong
Hong Kong, Hong Kong, 0000
3
Medanta Institute Of Digestive & Hepatobiliary Sciences
Haryāna, India
4
Asian Institute of Gastroenterology
Hyderabad, India