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

NCT04015193 | Unknown

• 1 other identifier: 201900110
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Mean finger ischemia time

  Mean finger ischemia time of five fingers during cooling and recovery, as assessed by routine cooling and recovery photo-electric plethysmography (PPG) after 5 years of follow-up, in minutes

  5 year

Secondary Outcomes (18)

• Mean finger ischemia time

  2 year

• Raynaud Condition Score

  1,2,3,4,5 years

• Number of attacks

  1,2,3,4,5 years

• Duration of attacks

  1,2,3,4,5 years

• SF-36

  1,2,3,4,5 years

Study Arms (3)

Full responders

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

Procedure: Single-port thoracoscopic sympathicotomy (patient care)

Partial responders

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

Procedure: Single-port thoracoscopic sympathicotomy (patient care)

Non-responders

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

Procedure: Single-port thoracoscopic sympathicotomy (patient care)

Interventions

Single-port thoracoscopic sympathicotomy (patient care) PROCEDURE

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

Full responders; Non-responders; Partial responders

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Raynaud's phenomenon

You may qualify if:

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

You may not qualify if:

• SPTS for other indications than RP

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

RECRUITING

MeSH Terms

Conditions

Raynaud Disease

Interventions

Patient Care

Condition Hierarchy (Ancestors)

Livedoid Vasculopathy; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Douwe J Mulder, MD, PhD

  University of Groninge, University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Douwe J Mulder, MD, PhD

CONTACT

+31503612943; d.j.mulder@umcg.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vascular internist, Principal investigator

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: July 10, 2019
• Study Start: March 28, 2019
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: July 10, 2019

Record last verified: 2019-07

Locations

NL (1)