Status:
COMPLETED
Lumen Apposing Metal Stents vs Double Pigtail Stents
Lead Sponsor:
John Gasdal Karstensen
Conditions:
Pancreatitis,Acute Necrotizing
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
While the majority of patients with acute pancreatitis suffer a mild and uncomplicated course of disease, up to 20% develop a more severe course with development of pancreatic and/or peripancreatic ne...
Eligibility Criteria
Inclusion
- Inclusion criteria (all criteria must be fulfilled):
- Patients with acute, necrotizing pancreatitis and
- WON exceeding a diameter of 15 cm (measured on contrast-enhanced CT (CECT); see details on imaging tests below). WON is defined based on the revised Atlanta criteria as a mature, encapsulated pancreatic or peripancreatic necrosis with a well-defined inflammatory wall\[12\].
- Imaging test(s) must be done within 1 week before the index drainage procedure.
- Debut of pancreatitis must be within 3 months before the index drainage procedure.
- One or more indication(s) for endoscopic, transmural drainage must be established:
- 1\. Confirmed or suspected infection.1 2. Severe intraabdominal hypertension or abdominal compartment syndrome. 3. Persisting abdominal pain, early satiety, or general discomfort. 4. Obstruction of the GI or biliary tract. 5. Leakage of pancreatic juice, e.g. ascites or pleural effusion.
- 3\. Preoperatively, the WON must be considered eligible for endoscopic, transgastric drainage with both conventional double pigtail and LAMS technique. Distance between the gastric wall and WON must not exceed one cm and there must be no major interposed vessels.
- Infection in WON:
- Confirmed infected necrosis is defined as a) positive culture from WON obtained by fine- needle aspiration prior to or at the first drainage procedure or b) presence of gas in WON on CECT prior to drainage with no earlier puncture/drainage and no signs of perforation to the GI tract.
- Infected necrosis is suspected when a patient with WON present with clinical signs of persistent sepsis without other causes of infection.
Exclusion
- Patients under the age of 18.
- Pregnancy.
- Known or suspected malignant disease.
- Pancreatitis secondary to trauma or surgical intervention.
- Chronic pancreatitis.
- Collections that may only be drained from the duodenum.
- Previous surgical or endoscopic drainage or necrosectomy.
Key Trial Info
Start Date :
August 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2022
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04057846
Start Date
August 29 2019
End Date
May 31 2022
Last Update
August 2 2022
Active Locations (1)
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1
Copenhagen University Hospital Hvidovre
Hvidovre, Capital, Denmark, 2650