Primairy 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.
ID
Bron
Verkorte titel
Aandoening
Acute necrotizing pancreatitis.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Extent and duration of recovery measured by the Sickness Impact Profile (SIP) after 12 weeks.
Achtergrond van het onderzoek
A 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.
Doel van het onderzoek
Primairy 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.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Patients will be randomly assigned to receive either endoscopic transmural debridement or standard conservative treatment.
Publiek
P.O. Box 22660
P. Fockens
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5669111
P.Fockens@amc.uva.nl
Wetenschappelijk
P.O. Box 22660
P. Fockens
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5669111
P.Fockens@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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 ìmol/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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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.
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL1145 |
NTR-old | NTR1187 |
Ander register | : MEC 07/281 |
ISRCTN | ISRCTN wordt niet meer aangevraagd |