Follow-up of SPTS in Patients With Raynaud's Phenomenon

U

University Medical Center Groningen (UMCG)

Status

Enrolling

Conditions

Raynaud Phenomenon

Treatments

Procedure: Single-port thoracoscopic sympathicotomy (patient care)

Study type

Observational

Funder types

Other

Identifiers

NCT04015193
201900110

Details and patient eligibility

About

Background: Raynaud's phenomenon is a vasospasm of the extremities, leading to extensive discomfort in daily life and potentially severe ischemia. Some patients are resistant to conventional vasodilatory drug treatment. In the University Medical Center Groningen, single-port thoracoscopic sympathicotomy (SPTS) was developed. This is a new minimally invasive endoscopic technique, extensively limiting surgical burden. In many hospitals in the Netherlands, this operation is sometimes performed on patients with Raynaud's phenomenon. However, the techniques used are more invasive than the SPTS technique. Furthermore, studies on sympathectomy and sympathicotomy in Raynaud's are limited and encompass obsolete more invasive techniques. Also, it is unclear which patients would benefit the most and for how long and in which percentage of patients treatment effects persist over time. In a recent study on the new SPTS technique, it was found that one month after the procedure, the Raynaud's attacks were substantially reduced and the hand perfusion increased on the operated side. Based on these short term effects and previously reported broad experience with this technique for other indications, it is possible to offer this option to a broader range of patients with Raynaud's as a reasonable and safe treatment option. However, whether the effects persist on the long-term needs to be established. Main research question: The aim of the study is to assess the 5 year efficacy and outcome in patients with primary and secondary Raynaud's phenomenon in whom SPTS has been performed. Design (including population, confounders/outcomes): Patients with Raynaud's, who will undergo SPTS in patient care setting, will be included. Data from the patient file will be collected, including vascular measurements to assess hand perfusion, a Raynaud diary (Raynaud condition score, duration and frequency of the attacks), quality of life questionnaires, and adverse events.

Enrollment

50 estimated patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Raynaud's phenomenon of the hands
  • Scheduled SPTS as treatment for RP
  • Age ≥ 16 years

Exclusion criteria

• SPTS for other indications than RP

Trial design

50 participants in 3 patient groups

Full responders
Description:
Full responders: no signs or symptoms of Raynaud's phenomenon (RP) in Raynaud condition score, no RP during cooling-recovery experiment.
Treatment:
Procedure: Single-port thoracoscopic sympathicotomy (patient care)
Partial responders
Description:
Partial responders: at least 25% reduction in Raynaud condition score and finger ischemia time during cooling and recovery.
Treatment:
Procedure: Single-port thoracoscopic sympathicotomy (patient care)
Non-responders
Description:
Non-responders: no or less than 25% reduction in Raynaud condition score and/or finger ischemia time during cooling and recovery.
Treatment:
Procedure: Single-port thoracoscopic sympathicotomy (patient care)

Trial contacts and locations

1

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Central trial contact

Douwe J Mulder, MD, PhD

Data sourced from clinicaltrials.gov

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