Standard CONservative approach versus endoscopic Debridement in patients with symptomatic sterile Organized pancreatic necRosis (CONDOR trial): a prospective randomised controlled trial
- Conditions
- Symptomatic strerile organized pancreatic necrosis after acute necrotizing pancreatitis1001796910017998
- Registration Number
- NL-OMON32422
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 58
*Presence of a single (>6cm), large, well defined (peri)pancreatic fluid collection on contrast-enhanced computed tomography (CECT) or a similar fluid collection on MRI also containing necrotic material larger than 1 cm in diameter.
*The presence of at least one of the following persistent symptoms, suspected to be caused by the fluid collection, despite of conservative treatment of minimally 6 weeks after onset of acute necrotizing pancreatitis: Severe abdominal pain, Gastric outlet obstruction or obstructive jaundice
* Window for transluminal endoscopic debridement
* Age equal to or above 18 years
* Written informed consent
* Infected pancreatic necrosis, defined as the presence of air in the collection on CECT.
* Suspected infected necrosis, defined as a rise of two out of three following parameters: >50% increase of leucocytes or CRP or temperature rises above 38,5oC within 72 hours.
* New failure of at least one of the following organs: cardiac, pulmonary or renal.
* Acute flare-up of chronic pancreatitis
* Previous endoscopic (transgastric or transduodenal), percutaneous or surgical drainage of a pancreatic fluid collection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Extent and duration of recovery measured by the Sickness Impact Profile (SIP)<br /><br>after 12 weeks. </p><br>
- Secondary Outcome Measures
Name Time Method <p>SIP scores after 26 and 52 weeks, total out of hospital days, resolution and<br /><br>recurrence of the pancreatic fluid collection, intervention-related<br /><br>complications, mortality, total number of interventions, endocrine and exocrine<br /><br>function and (in)direct costs. </p><br>