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
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Extent and duration of recovery measured by the Sickness Impact Profile (SIP)
after 12 weeks.
Secondary outcome
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.
Background summary
Pancreatic necrosis is a severe complication of acute pancreatitis. Infected
necrosis is generally accepted as an indication for surgery. Majority of
patients with sterile necrosis can be successfully treated without
intervention. However a subgroup of patients with sterile necrosis suffers from
persisting symptoms of residual pain, difficulty eating, jaundice, malaise,
subfebrile temperature and general lack of wellbeing resulting in high health
care utilization and preventing return to work for many months. Surgical
management is however associated with significant morbidity and mortality. By
the time necrosis becomes organized, endoscopic therapy has the potential to
offer an alternative treatment. Recently we have performed a retrospective
study of all patients treated with transmural endoscopic debridement with
compelling results. Because of the minimal invasiveness, compelling initial
results and relative safeness, endoscopic debridement could be of benefit in
patients with sterile pancreatic necrosis who suffer from longstanding *failure
to thrive* after the acute fase of necrotizing pancreatitis.
Study objective
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.
Study design
A multicenter randomised controlled, clinical trial.
Intervention
Patients will be randomly assigned to receive either endoscopic transmural
debridement or standard conservative treatment.
Study burden and risks
Main burden are the extra endoscopic procedures which need to be performed.
Consequently there will be a small risk of bleeding or perforation. In the
participating centers there will be adequate experience with this
interventional technique.
The patients treated conservatively will be at risk of complications of the
remaining necrosis, for expamle infection. There also will be a chance that
symptoms will persist and patients still need to underwent an endoscopic
intervenion.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
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
* 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL20219.018.07 |