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

NCT ID: NCT04015193

Last Updated: 2019-07-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-28
• Study Completion Date: 2025-03-01

Brief Summary

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.

Conditions

Raynaud Phenomenon

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Full responders

Full responders: no signs or symptoms of Raynaud's phenomenon (RP) in Raynaud condition score, no RP during cooling-recovery experiment.

Single-port thoracoscopic sympathicotomy (patient care)

Intervention Type: PROCEDURE

Single-port thoracoscopic sympathicotomy will be performed as part of patient care, data will be collected of patients undergoing this procedure

Partial responders

Partial responders: at least 25% reduction in Raynaud condition score and finger ischemia time during cooling and recovery.

Single-port thoracoscopic sympathicotomy (patient care)

Intervention Type: PROCEDURE

Single-port thoracoscopic sympathicotomy will be performed as part of patient care, data will be collected of patients undergoing this procedure

Non-responders

Non-responders: no or less than 25% reduction in Raynaud condition score and/or finger ischemia time during cooling and recovery.

Single-port thoracoscopic sympathicotomy (patient care)

Intervention Type: PROCEDURE

Single-port thoracoscopic sympathicotomy will be performed as part of patient care, data will be collected of patients undergoing this procedure

Interventions

Single-port thoracoscopic sympathicotomy (patient care)

Single-port thoracoscopic sympathicotomy will be performed as part of patient care, data will be collected of patients undergoing this procedure

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

dr. DJ Mulder

Vascular internist, Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Douwe J Mulder, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Groninge, University Medical Center Groningen

Locations

University Medical Center Groningen

Groningen, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Douwe J Mulder, MD, PhD

Role: CONTACT

d.j.mulder@umcg.nl

+31503612943

Facility Contacts

Douwe J Mulder, MD, PhD

Role: primary

d.j.mulder@umcg.nl

+31-50-3612350

Other Identifiers

201900110

Identifier Type: -

Identifier Source: org_study_id