Raynaud PhenomenonNCT04015193
Follow-up of SPTS in Patients With Raynaud's Phenomenon
An observational study of Raynaud Phenomenon, run by University Medical Center Groningen at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Raynaud Phenomenon
- What is being tested?
- Single-port thoracoscopic sympathicotomy (patient care)
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Mar 2019to 1 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Raynaud's phenomenon
Who may be able to join
- Raynaud's phenomenon of the hands
- Scheduled SPTS as treatment for RP
- Age ≥ 16 years
Who cannot join
- SPTS for other indications than RP
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen, 9700 RB
Douwe J Mulder, MD, PhD, +31-50-3612350, d.j.mulder@umcg.nl
Douwe J. Mulder, MD, PhD
About this study
Official title: 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.
- Conditions
- Raynaud Phenomenon
- Being tested
- Single-port thoracoscopic sympathicotomy (patient care)
- Medical subject headings
- Raynaud Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-port thoracoscopic sympathicotomy (patient care)Procedure or surgery
Single-port thoracoscopic sympathicotomy will be performed as part of patient care, data will be collected of patients undergoing this procedure
| Study group | Role | What they receive |
|---|---|---|
| Full responders | Full responders: no signs or symptoms of Raynaud's phenomenon (RP) in Raynaud condition score, no RP during cooling-recovery experiment. Receives: 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. Receives: 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. Receives: Procedure: Single-port thoracoscopic sympathicotomy (patient care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 year
Secondary outcomes (18)
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
Measured: 2 year
Raynaud Condition Score
Mean Raynaud condition score (0-100) over a period 14 days
Measured: 1,2,3,4,5 years
Number of attacks
Mean number of RP attacks per day over a period of 14 days
Measured: 1,2,3,4,5 years
Duration of attacks
Mean duration of RP attacks per day over a period of 14 days in minutes
Measured: 1,2,3,4,5 years
SF-36
Health-related quality of life short form (SF)-36 score of 100-0
Measured: 1,2,3,4,5 years
HAQ
(Dutch) health assessment questionnaire (HAQ) score of 0-3
Measured: 1,2,3,4,5 years
Capillary density
Mean number of capillaries per finger of 8 fingers per 3mm
Measured: 2 and 5 years
Number of dilated capillaries
Mean number of dilated capillaries per finger (apex width >20µm, <50µm) of 8 fingers per 3mm
Measured: 2 and 5 year
Number of giant capillaries
Mean number of giant capillaries per finger (apex width >50µm) of 8 fingers per 3mm
Measured: 2 and 5 year
Capillaroscopic pattern
Pattern of nailfold capillaries (normal, non-specific, early, active or late)
Measured: 2 and 5 year
Pulse wave velocity brachial-radial
Pulse wave velocity in m/s of brachial-radial trajectory
Measured: 2 and 5 years
Systolic blood pressure
Brachial systolic blood pressure in mmHg
Measured: 2 and 5 years
Diastolic blood pressure
Brachial diastolic blood pressure in mmHg
Measured: 2 and 5 years
Mean finger blood pressure
Mean finger blood pressure in mmHg of eight fingers
Measured: 2 and 5 years
Pulse wave velocity brachial-ulnar
Pulse wave velocity in m/s of brachial-ulnar trajectory
Measured: 2 and 5 years
Digital ulcers
Incidence of digital ulcers (yes/no)
Measured: 1,2,3,4,5 years
Compensatory sweating
Compensatory sweating (yes/no)
Measured: 1,2,3,4,5 years
Wound infection or other adverse events
Occurrence of wound infection or other adverse events potentially related to SPTS
Measured: 2 weeks, 1,2,3,4,5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start28 Mar 2019
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Raynaud PhenomenonStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. DJ Mulder, University Medical Center Groningen
- Investigators
- Douwe J Mulder, MD, PhD, Principal investigator, University of Groninge, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04015193
- Sponsor's protocol ID
- 201900110
- Status last verified
- Jul 2019
- First submitted
- 1 Apr 2019
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of Single-port Thoracoscopic Sympathicotomy in Patients With Raynaud's Phenomenon
- ClinicalTrials.gov ID
- NCT04015193
- Acronym / sponsor ID
- 201900110
- Conditions
- Raynaud Phenomenon
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 28 Mar 2019 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 10 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Full responders | – | Procedure: Single-port thoracoscopic sympathicotomy (patient care)Full responders: no signs or symptoms of Raynaud's phenomenon (RP) in Raynaud condition score, no RP during cooling-recovery experiment. |
| Partial responders | – | Procedure: Single-port thoracoscopic sympathicotomy (patient care)Partial responders: at least 25% reduction in Raynaud condition score and finger ischemia time during cooling and recovery. |
| Non-responders | – | Procedure: Single-port thoracoscopic sympathicotomy (patient care)Non-responders: no or less than 25% reduction in Raynaud condition score and/or finger ischemia time during cooling and recovery. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Raynaud's phenomenon
Key inclusion criteria (3 listed)
- Raynaud's phenomenon of the hands
- Scheduled SPTS as treatment for RP
- Age ≥ 16 years
Key exclusion criteria (1 listed)
- SPTS for other indications than RP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | Full responders, Non-responders, Partial responders |
Primary outcome
Mean finger ischemia time
Time frame: 5 year
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
18 secondary outcomes
Mean finger ischemia time
Time frame: 2 year
Raynaud Condition Score
Time frame: 1,2,3,4,5 years
Number of attacks
Time frame: 1,2,3,4,5 years
Duration of attacks
Time frame: 1,2,3,4,5 years
SF-36
Time frame: 1,2,3,4,5 years
HAQ
Time frame: 1,2,3,4,5 years
Capillary density
Time frame: 2 and 5 years
Number of dilated capillaries
Time frame: 2 and 5 year
Number of giant capillaries
Time frame: 2 and 5 year
Capillaroscopic pattern
Time frame: 2 and 5 year
Pulse wave velocity brachial-radial
Time frame: 2 and 5 years
Systolic blood pressure
Time frame: 2 and 5 years
Diastolic blood pressure
Time frame: 2 and 5 years
Mean finger blood pressure
Time frame: 2 and 5 years
Pulse wave velocity brachial-ulnar
Time frame: 2 and 5 years
Digital ulcers
Time frame: 1,2,3,4,5 years
Compensatory sweating
Time frame: 1,2,3,4,5 years
Wound infection or other adverse events
Time frame: 2 weeks, 1,2,3,4,5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douwe J Mulder, MD, PhD principal investigator
University of Groninge, University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Raynaud Phenomenon, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Douwe J Mulder, MD, PhD (+31503612943, d.j.mulder@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean finger ischemia time (time frame: 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.