The POINTER trial investigates whether immediate treatment with catheter drainage is superior to the current practice of postponed catheter drainage within the step-up approach in patients with infected necrotizing pancreatitis.
ID
Source
Brief title
Condition
- Other condition
- Gastrointestinal inflammatory conditions
Synonym
Health condition
Geïnfecteerde necrotiserende pancreatitis
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome consists of the Comprehensive Complication Index (CCI),
including all complications between randomization and 6 months after.
Secondary outcome
Secondary outcome are: mortality, new onset (multi) organ failure, bleeding
requiring intervention, perforation requiring intervention, fistula, incisional
hernia, wound infections, endocrine and exocrine pancreas insufficiency, number
of patients with severe complications (Clavien-Dindo III or higher), number of
patients per Clavien-Dindo classification, number of (re-)interventions,
hospital and ICU length of stay, QALYs, (in)direct costs, and budget impact.
Background summary
Infected necrotizing pancreatitis complicates 10% of all acute pancreatitis
episodes and is associated with a 20% mortality. Currently the step-up approach
(first catheter drainage, if necessary followed by a minimally invasive
necrosectomy) is the treatment of choice. The optimal strategy regarding
identifying infected necrosis, and next timing of catheter drainage once
infection is suspected or confirmed, has not been determined. Currently, all
interventions (both diagnostic and therapeutic) in patients with necrotizing
pancreatitis are often postponed until the stage of walled-off necrosis has
been reached, a process that usually takes 4 weeks. It is unclear whether this
delay is needed in the current era of catheter drainage as initial intervention
step and whether it could actually be detrimental to the patient.
Study objective
The POINTER trial investigates whether immediate treatment with catheter
drainage is superior to the current practice of postponed catheter drainage
within the step-up approach in patients with infected necrotizing pancreatitis.
Study design
A pragmatic parallel group randomized controlled multicenter superiority trial.
Intervention
Immediate catheter drainage after diagnosing infected necrosis while starting
antibiotic treatment. If necessary necrosectomy will be performed and
postponed, if feasible, until the stage of walled-off necrosis. This strategy
will be compared to current standard treatment; catheter drainage will be
postponed under antibiotic treatment. If necessary necrosectomy will be
performed and postponed, if feasible, until the stage of walled-off necrosis.
Study burden and risks
Included patients will undergo the same treatment and follow-up as non-included
patients, with the only difference undergoing earlier catheter drainage in the
intervention arm of the trial. The follow-up will be standardized at 3 and 6
months after randomization and exist of normal outpatient visits (including
imaging) and completing two questionnaires.
Meibergdreef 9 9
Amsterdam 1105 AZ
NL
Meibergdreef 9 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Documented infected necrotizing pancreatitis
- Suspected infected necrotizing pancreatitis (if > 14 days after onset of
acute pancreatitis)
- Catheter drainage of the collection with infected necrosis is technically
feasible
- Age >= 18 years
Exclusion criteria
- > 35 days after onset of acute pancreatitis
- Indication for emergency laparotomy for abdominal catastrophe (e.g. bleeding,
bowel perforation, abdominal compartment syndrome)
- Previous retroperitoneal intervention for necrotizing pancreatitis
- Documented chronic pancreatitis
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 | NL52361.018.15 |