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

Raynaud Phenomenon Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04015193
• Other study ID #: 201900110
• Status: Recruiting
• Start date: March 28, 2019
• Est. completion date: March 1, 2025

Study information

• Verified date: July 2019
• Source: University Medical Center Groningen
• Contact: Douwe J Mulder, MD, PhD
• Phone: +31503612943
• Email: d.j.mulder[@]umcg.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Raynaud Disease
• Raynaud Phenomenon

Intervention

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

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

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