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

Standard CONservative approach versus endoscopic Debridement in patients with symptomatic sterile Organized pancreatic necRosis (CONDOR trial): a prospective randomised controlled trial - CONDOR

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON32422

Enrollment

Registered

2008-01-14

Start date

2007-12-01

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Symptomatic strerile organized pancreatic necrosis after acute necrotizing pancreatitis

Interventions

Patients will be randomly assigned to receive either endoscopic transmural debridement or standard conservative treatment.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: *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

Exclusion criteria

Exclusion criteria: * 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

Design outcomes

Primary

Measure	Time frame
Extent and duration of recovery measured by the Sickness Impact Profile (SIP) after 12 weeks.	—

Secondary

Measure	Time frame
SIP 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, endocrine and exocrine function and (in)direct costs.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)