To determine the effectiveness and, subsequently, the cost-effectiveness of a endoscopic transluminal step-up approach (ETD & ETN) versus a surgical step-up approach (PCD & VARD ,if not possible laparotomy) to improve clinical outcome in…
ID
Source
Brief title
Condition
- Gastrointestinal infections
- Bacterial infectious disorders
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is composite of mortality and major morbidity. Major
morbidity is defined as new onset organ failure (cardiac, pulmonary or renal),
bleeding requiring intervention, perforation of a visceral organ (except for
the stomach in ETN) requiring intervention, enterocutaneous fistula requiring
intervention and incisional hernia (including burst abdomen).
Secondary outcome
Secondary endpoints are the individual components of the primary endpoint,
other morbidity such as pancreaticocutaneous fistula, exocrine and/or endocrine
pancreatic insufficiency, development of additional fluid collections requiring
intervention, biliairy strictures, wound infections, the need for necrosectomy
(either endoscopically or surgically), the total number of surgical, endoscopic
or radiological (re-) interventions, total length of intensive care- and
hospital stay, quality of life, costs per patient with poor outcome, costs per
QALY, total direct and indirect medical costs and the total number of
cross-over between groups.
Other research questions:
Is endoscopic transluminal catheter drainage (ETD) equally effective as
percutaneous catheter drainage (PCD) in preventing necrosectomy?
Background summary
Infected necrotising pancreatitis is a dangerous, potentially lethal disease,
that requires intervention. It is associated with prolonged hospital stay and
high costs. It has been shown that catheter drainage is the optimal first step
in the treatment of infected necrosis. Recent literature suggests that the
endoscopic transluminal step-up approach (endoscopic transluminal catheter
drainage (ETD) and necrosectomy (ETN) as the second step), may further improve
outcome (risk of mortality and major morbidity) compared to the surgical
step-up approach (consisting of percutaneous catheter drainage (PCD) and
surgical necrosectomy (VARD, if not possible laparotomy) as the second step).
Study objective
To determine the effectiveness and, subsequently, the cost-effectiveness of a
endoscopic transluminal step-up approach (ETD & ETN) versus a surgical step-up
approach (PCD & VARD ,if not possible laparotomy) to improve clinical outcome
in patients with (suspected or confirmed) infected necrotizing pancreatitis.
Study design
Randomized controlled, parallel group superiority multicenter trial with a
follow-up of 6 months after randomisation for the primary endpoint, secondary
endpoint and the other research questions.
Intervention
Endoscopic transluminal step-up approach (ETD and ETN).
Study burden and risks
In the endoscopic transluminal step-up approach group, the patient will
initially be drained endoscopically transluminally. If the patient does not
show clinical improvement within 72 hours, endoscopic transluminal necrosectomy
will take place. The study entails little additional risks. The endoscopic
transluminal step-up approach is already enrolled in many centers around the
world and published literature shows that it is a safe technique that, compared
to the surgical step-up approach is associated with few complications. Both
approaches are applied only by experienced specialists in experienced centers.
Postbus 9101 -
Nijmegen 6500 HB
NL
Postbus 9101 -
Nijmegen 6500 HB
NL
Listed location countries
Age
Inclusion criteria
* Pancreatic necrosis and/or peripancreatic necrosis with (suspected or confirmed) infection. (See protocol, page 15-16 for definitions)
* The peripancreatic collection is amenable to the endoscopic transluminal step-up approach as well as the surgical step-up approach.
* Age * 18 years and informed consent.
Exclusion criteria
* Previous surgical, endoscopic or percutaneous intervention for pancreatic necrosis and/or peripancreatic necrosis and/or peripancreatic collections. (See protocol, page 16 for definition)
* Acute flare up of chronic pancreatitis.
* Concomitant indication for laparotomy because of suspected abdominal compartment syndrome, bleeding or perforation of a visceral organ.
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 | NL33422.018.10 |