To determine the value of multimodality image registration of cone-beam CT (CBCT) and CT in increasing the success rate of adrenal vein sampling procedure compared to procedures without CBCT guidance.
ID
Source
Brief title
Condition
- Adrenal gland disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main parameter is the success rate of the AVS procedures with and without
multimodality image registration.
Secondary outcome
Other parameters are radiation dose, number of DSA runs used, used volume of
contrast agent, fluoroscopy time, and sampling time
Background summary
Adrenal vein sampling (AVS) is the gold standard in differentiating between
unilateral and bilateral hypersecretion of aldosterone by the adrenal glands.
However, it is a complex procedure with high failure rates. Locating and
sampling the right adrenal vein is the most difficult part. Using image
guidance visualizing the adrenal veins can possibly aid in AVS procedures and
increase the success rate.
Study objective
To determine the value of multimodality image registration of cone-beam CT
(CBCT) and CT in increasing the success rate of adrenal vein sampling procedure
compared to procedures without CBCT guidance.
Study design
Open randomized controlled trial to compare AVS procedures with and without
multimodality image registration.
Study burden and risks
The CT scan and AVS procedure involve X-ray imaging. Both are performed as
clinical care and conform clinical practice. The study group will receive an
additional CBCT scan, however, we expect the total radiation dose of the
procedure not to increase compared to the standard protocol. Therefore, we
assume that there will be no additional risk to the patients participating in
this study compared to the standard clinical care. In case the success rate of
the AVS procedures increases with multimodality image registration, the benefit
for the total group of patients is a reduction in repeat AVS procedures because
of procedure failure and thus overall radiation dose reduction. Other
parameters that might be beneficially influenced by multimodality image
registration for the total patient group are reduced sampling time and
reduction of used contrast volume.
Geert Grooteplein 10
Nijmegen 6525 GA
NL
Geert Grooteplein 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
diagnosed with primary hyperaldosteronism and referred for adrenal vein sampling
Exclusion criteria
none
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 | NL41450.091.13 |