Status:
UNKNOWN
Plastic Stents vs. NAGI Bi-flanged Metal Stent for Endoscopic Ultrasound Guided Drainage of Walled-off Necrosis
Lead Sponsor:
Asian Institute of Gastroenterology, India
Conditions:
Acute Necrotizing Pancreatitis
Walled Off Necrosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Introduction: Walled off necrosis (WON) is defined as a well circumscribed pancreatic and/or peri pancreatic necrosis containing a variable amount of necrotic tissue. WON usually occurs \>4 weeks aft...
Detailed Description
1.1 Patient recruitment Patients would be recruited from the in-patient or outpatient department prior to their scheduled endoscopic intervention. 1.2 Study design This is a single center randomized ...
Eligibility Criteria
Inclusion
- Adult \>18 years,
- Patient with symptomatic WON
- Debris \<50% (based on cross sectional imaging)
- Written informed consent
Exclusion
- Pregnancy or breast feeding,
- Severe coagulopathy INR \>1.5 which is not correctable and/or platelets \<50000/mm3
- Endoscopic drainage is technically not feasible
- Fluid collections other than WON
- Patient who is unable to understand study protocol or not willing for follow-up requirements
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04479228
Start Date
August 1 2020
End Date
January 1 2022
Last Update
July 21 2020
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