To quantify blood-flow changes after unilateral sympathicotomy
ID
Source
Brief title
Condition
- Vascular haemorrhagic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cooling pletysmography
Nailbed microscopy
Secondary outcome
Quality of life
Comlaints diary
Background summary
Raynaud phenomenon is a disease affecting predominantly young people, leading
to painful, cold and white fingers, often impairing hand and finger function.
Treatments excist, including medication. However, a number of patients do not
respond to all known treatments. In this group we would like to evaluate the
effect of a minimal invasive sympathicotomy (intra-thoracic lesion of the
sympathetic nerve). This treatment is frequently used in patients with severe
hyperhidrosis of the hands and axillary region, not responding to other
treatments. Since in this patients a known (side) effects is a increase in
manual blood flow, it makes sense to deduct that people suffering from severe
raynaud's will benefit to.
Study objective
To quantify blood-flow changes after unilateral sympathicotomy
Study design
Single-center feasibility study in 10 patients. Unilateral intervention en
quantification of blood-flow and quality of life. When effective, treatment on
the opposite side will be offered.
Intervention
Unilateral single-port sympathicotomy
Study burden and risks
The complaints in this patients group are very intense. The minimal invasive
procedure might offer a elegant, permanent solution, without serious risks.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
18-65 years of age
Severe form of RP, defined as clinical need of prostacyclin analogue infusions having been given in the preceding 2 years, without satisfying result OR
Severe form of RP, defined as clinical limiting in everyday life for the patient with presence of a contra-indication for prostacyclin, without satisfying result of standard care.
Exclusion criteria
- Due to higher risk of complications following unilateral lung-deflation and re-insufflation:
o Known COPD with evidence of emphysematous lung destruction on X-thorax or CT
o History of smoking > 20 pack years
o Lung involvement due to systemic autoimmune disease (based on previously described abnormalities on HRCT or documented pulmonary hypertension by mean pulmonary artery pressure 25 mmHg at rest measured by right heart catherisation).
- Concurrent neurological disease
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 |
|---|---|
| ClinicalTrials.gov | NCTvolgtnog |
| CCMO | NL52348.042.15 |