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Standard CONservative approach versus endoscopic Debridement in patients with symptomatic sterile Organized pancReatic necrosis (CONDOR trial): a prospective randomised controlled trial.


- candidate number3009
- NTR NumberNTR1187
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-jan-2008
- Secondary IDsMEC 07/281 
- Public TitleStandard CONservative approach versus endoscopic Debridement in patients with symptomatic sterile Organized pancReatic necrosis (CONDOR trial): a prospective randomised controlled trial.
- Scientific TitleStandard CONservative approach versus endoscopic Debridement in patients with symptomatic sterile Organized pancReatic necrosis (CONDOR trial): a prospective randomised controlled trial.
- ACRONYMCONDOR
- hypothesisPrimairy aim is to compare endoscopic transmural debridement with standard conservative treatment in patients with symptomatic sterile organized pancreatic necrosis in a randomized controlled trial with emphasis on extent and duration of recovery.
- Healt Condition(s) or Problem(s) studiedAcute necrotizing pancreatitis
- Inclusion criteria1. 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;
2. 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:
a. Severe abdominal pain, defined as abdominal pain insufficiently relieved by non-narcotic analgesic (paracetamol (max 4000 mg/ day) and NSAIDS (equivalent to diclofenac (max 150 mg/day)) or requiring opiates;
b. Gastric outlet obstruction, defined as inability to tolerate oral solid intake or the need for gastro-jejeunal tube feeding;
c. Obstructive jaundice, dark urine, pale stools and serum total bilirubine values increased above 50 ýmol/l;
3. Fluid collection is in the immediate proximity of stomach and/or duodenum and seems to be accessible to endoscopic drainage based on the CT- or MRI-information;
4. Age equal to or above 18 years;
5. Written informed consent.
- Exclusion criteria1. Infected pancreatic necrosis, defined as the presence of air in the collection on CECT;
2. Suspected infected necrosis, defined as a rise of two out of three following parameters:>50% increase of leucocytes (minimal >15 10E9/L) or CRP (minimal >50 mg/L) or temperature rises above 38,5oC within 72 hours (with exclusion of other infectious causes);
3. New failure of at least one of the following organs: cardiac, pulmonary or renal;
4. Acute flare-up of chronic pancreatitis;
5. Previous endoscopic (transgastric or transduodenal), percutaneous or surgical drainage of a pancreatic fluid collection;
6. Unable to undergo upper gastrointestinal endoscopy.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 2-feb-2008
- planned closingdate1-jan-2010
- Target number of participants58
- InterventionsPatients will be randomly assigned to receive either endoscopic transmural debridement or standard conservative treatment.
- Primary outcomeExtent and duration of recovery measured by the Sickness Impact Profile (SIP) after 12 weeks.
- Secondary outcomeSIP scores after 26 and 52 weeks, total out of hospital days, resolution and recurrence of the pancreatic fluid collection, intervention-related complications, mortality, total number of interventions and (in)direct costs.
- TimepointsN/A
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. P. Fockens
- CONTACT for SCIENTIFIC QUERIESDr. P. Fockens
- Sponsor/Initiator Academic Medical Center (AMC), Department of Gastroenterology
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Department of Gastroenterology
- PublicationsN/A
- Brief summaryA randomized trial comparing standard conservative approach versus endoscopic debridement in patients with symptomatic sterile organized pancreatic necrosis with emphasis on extent and duration of recovery.
- Main changes (audit trail)
- RECORD16-jan-2008 - 17-apr-2008


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