To determine the feasibility of performing US-guided synovitis and tenosynovitis in wrist and MCP-joints, and investigate the quality and quantity of the obtained tissues.
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Success rate of US-guided synovitis and tenosynovitis biopsy, which is based on
the quality and quantity of the obtained tissues.
Secondary outcome
NA
Background summary
The mechanisms underlying arthritis becoming chronic are poorly understood. The
development of rheumatoid arthritis (RA) is considered to be a multiple-hit
process that is largely taking place before the disease presents with
clinically swollen joints. The disease is characterised by inflammation of
synovium, preferentially the joints of the hands. Research, from our own
department using MRI, showed that RA is also characterized by inflammation of
the tenosynovium, as tenosynovitis is present in >85% of RA-patients at the
time of diagnosis. Furthermore tenosynovitis is one of the first features of
developing RA. Tissue research has so far focussed on synovitis, using
established molecular techniques on biopsies from patients with established
disease. Ultrasound (US)-guided synovial biopsy techniques have been developed,
also for hand joints, and proved reliable, minimally invasive, well-tolerated
and safe when grade 2 inflammation is present. Whilst established molecular
techniques require relatively large tissue samples, novel techniques have
developed, such a single cell sequencing and imaging mass cytometry, which
provide unprecedented possibilities to discover (novel) cells characterizing
disease and require only small tissue fragments. This would allow to perform
molecular studies of synovitis and tenosynovitis from hand joints in patients
in early phases of RA. Other European groups performing US-guided biopsies,
showed that sufficient material for analyses could be obtained in ~60-90% of
patients biopsied, and that this material was representative of the joint
status in small joints of RA-patients. We aim to determine if it is feasible in
our center to perform US-guided synovitis and tenosynovitis biopsies in the
metacarpophalangeal (MCP)- or wrist joints with grade 2 inflammation and
analysis the obtained tissues. If successful we aim to expand the study in
patients with early stages of RA to enhance our understanding of
RA-pathogenesis and promote subsequent development of targeted therapies
Study objective
To determine the feasibility of performing US-guided synovitis and
tenosynovitis in wrist and MCP-joints, and investigate the quality and quantity
of the obtained tissues.
Study design
This is a cross-sectional observational study.
Study burden and risks
Patients will have US-guided biopsy. Patients will have no benefits when
participating in this study. Results, which are molecular analyses of
(teno)synovium tissue, will not be communicated to rheumatologists or patients.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
- Patients referred to rheumatology outpatient clinic (LUMC).
- Age >=18 years.
- Grade >=2 synovitis or tenosynovitis.
- Consent to comply with the requirements of the study protocol.
Exclusion criteria
- Contraindications to ultrasound-guided biopsy, such as active skin infection
and anticoagulant/antiplatelet treatment.
- Known for lidocaine-allergy
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL75734.058.20 |