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

Follow-up of Single-port Thoracoscopic Sympathicotomy in Patients With Raynaud's Phenomenon

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.

Study Overview

• Status: Recruiting
• Conditions: Raynaud Phenomenon
• Intervention / Treatment: Procedure: Single-port thoracoscopic sympathicotomy (patient care)

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Douwe J Mulder, MD, PhD; Phone Number: +31503612943; Email: d.j.mulder@umcg.nl

Study Locations

• Netherlands
  • Groningen, Netherlands, 9700 RB
    • Recruiting
    • University Medical Center Groningen
    • Contact: Douwe J Mulder, MD, PhD; Phone Number: +31-50-3612350; Email: d.j.mulder@umcg.nl
    • Principal Investigator: Douwe J. Mulder, MD, PhD
    • Sub-Investigator: Anniek M. van Roon
    • Sub-Investigator: Michiel Kuijpers, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Raynaud's phenomenon

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); 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.	Procedure: 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
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); Single-port thoracoscopic sympathicotomy will be performed as part of patient care, data will be collected of patients undergoing this procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 2 years of follow-up, in minutes	2 year
Raynaud Condition Score	Mean Raynaud condition score (0-100) over a period 14 days	1,2,3,4,5 years
Number of attacks	Mean number of RP attacks per day over a period of 14 days	1,2,3,4,5 years
Duration of attacks	Mean duration of RP attacks per day over a period of 14 days in minutes	1,2,3,4,5 years
SF-36	Health-related quality of life short form (SF)-36 score of 100-0	1,2,3,4,5 years
HAQ	(Dutch) health assessment questionnaire (HAQ) score of 0-3	1,2,3,4,5 years
Capillary density	Mean number of capillaries per finger of 8 fingers per 3mm	2 and 5 years
Number of dilated capillaries	Mean number of dilated capillaries per finger (apex width >20µm, <50µm) of 8 fingers per 3mm	2 and 5 year
Number of giant capillaries	Mean number of giant capillaries per finger (apex width >50µm) of 8 fingers per 3mm	2 and 5 year
Capillaroscopic pattern	Pattern of nailfold capillaries (normal, non-specific, early, active or late)	2 and 5 year
Pulse wave velocity brachial-radial	Pulse wave velocity in m/s of brachial-radial trajectory	2 and 5 years
Systolic blood pressure	Brachial systolic blood pressure in mmHg	2 and 5 years
Diastolic blood pressure	Brachial diastolic blood pressure in mmHg	2 and 5 years
Mean finger blood pressure	Mean finger blood pressure in mmHg of eight fingers	2 and 5 years
Pulse wave velocity brachial-ulnar	Pulse wave velocity in m/s of brachial-ulnar trajectory	2 and 5 years
Digital ulcers	Incidence of digital ulcers (yes/no)	1,2,3,4,5 years
Compensatory sweating	Compensatory sweating (yes/no)	1,2,3,4,5 years
Wound infection or other adverse events	Occurrence of wound infection or other adverse events potentially related to SPTS	2 weeks, 1,2,3,4,5 years

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Investigators: Principal Investigator: Douwe J Mulder, MD, PhD, University of Groninge, University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2019
• Primary Completion (Anticipated): March 1, 2025
• Study Completion (Anticipated): March 1, 2025

Study Registration Dates

• First Submitted: April 1, 2019
• First Submitted That Met QC Criteria: July 8, 2019
• First Posted (Actual): July 10, 2019

Study Record Updates

• Last Update Posted (Actual): July 10, 2019
• Last Update Submitted That Met QC Criteria: July 8, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Peripheral Vascular Diseases; Raynaud Disease
• Other Study ID Numbers: 201900110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No