To compare endoscopic pancreatic fluid collection drainage using a standard oblique-viewing US endoscope versus a prototype forward viewing ultrasonic endoscope with emphasis on ease of endoscopic drainage measured by procedural time.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint will be ease of endoscopic drainage measured by procedural
time.
Secondary outcome
Successful drainage procedures, resolution of pancreatic fluid collections,
procedure related complications, US endoscope preference according to
post-procedural questionnaire.
Background summary
Transmural endoscopic drainage has become treatment of first choice for
uncomplicated pancreatic fluid collections. Drainage is mostly performed with
presently available therapeutic oblique-viewing (45°) ultrasonic endoscopes.
Puncturing under an angle sometimes hampers successful completion of the
procedure because the force that is applied while introducing instruments
through the working channel is not fully exerted at the tip of the accessory,
but instead drives the endoscope away from the gut wall. A prototype forward
viewing ultrasonic endoscope was developed to overcome this difficulty.
Study objective
To compare endoscopic pancreatic fluid collection drainage using a standard
oblique-viewing US endoscope versus a prototype forward viewing ultrasonic
endoscope with emphasis on ease of endoscopic drainage measured by procedural
time.
Study design
A multicenter randomised controlled, clinical trial
Intervention
Patients will be randomly assigned to receive either endoscopic drainage with a
forward viewing or standard oblique viewing ultrasonic endoscope.
Study burden and risks
Because endoscopic drainage will be indicated in all patients, the extra burden
will be limited. There will be a small chance that endoscopic drainage is not
successful with the prototype forward viewing US endoscope. Consequently, the
procedure need to be repeated with a standard oblique viewing endoscope. On the
other hand, it may happen that a pancreatic fluid collection can be drained
with the forward viewing and NOT with the standard oblique viewing, and
participating in this study may appear to be beneficial.
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
* Presence of a large (> 6 cm) pancreatic fluid collection.
* Window for endoscopic drainage
* Age > 17 years
* Written informed consent
Exclusion criteria
* Previous surgical or endoscopic drainage
* Participation in another intervention trial that would interfere with the intervention and outcome of this study.
* Transduodenal as the preferred route
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 | NL22387.018.08 |