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.
Condition or disease | Intervention/treatment |
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Raynaud Phenomenon | Procedure: Single-port thoracoscopic sympathicotomy (patient care) |
Study Type : | Observational |
Estimated Enrollment : | 50 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Follow-up of Single-port Thoracoscopic Sympathicotomy in Patients With Raynaud's Phenomenon |
Actual Study Start Date : | March 28, 2019 |
Estimated Primary Completion Date : | March 1, 2025 |
Estimated Study Completion Date : | March 1, 2025 |
Group/Cohort | Intervention/treatment |
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Full responders
Full responders: no signs or symptoms of Raynaud's phenomenon (RP) in Raynaud condition score, no RP during cooling-recovery experiment.
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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
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Partial responders
Partial responders: at least 25% reduction in Raynaud condition score and finger ischemia time during cooling and recovery.
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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
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Non-responders
Non-responders: no or less than 25% reduction in Raynaud condition score and/or finger ischemia time during cooling and recovery.
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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
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Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
• SPTS for other indications than RP
Contact: Douwe J Mulder, MD, PhD | +31503612943 | d.j.mulder@umcg.nl |
Netherlands | |
University Medical Center Groningen | Recruiting |
Groningen, Netherlands, 9700 RB | |
Contact: Douwe J Mulder, MD, PhD +31-50-3612350 d.j.mulder@umcg.nl | |
Principal Investigator: Douwe J. Mulder, MD, PhD | |
Sub-Investigator: Anniek M. van Roon | |
Sub-Investigator: Michiel Kuijpers, MD |
Principal Investigator: | Douwe J Mulder, MD, PhD | University of Groninge, University Medical Center Groningen |
Tracking Information | |||||
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First Submitted Date | April 1, 2019 | ||||
First Posted Date | July 10, 2019 | ||||
Last Update Posted Date | July 10, 2019 | ||||
Actual Study Start Date | March 28, 2019 | ||||
Estimated Primary Completion Date | March 1, 2025 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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
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Original Primary Outcome Measures | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Follow-up of SPTS in Patients With Raynaud's Phenomenon | ||||
Official Title | Follow-up of Single-port Thoracoscopic Sympathicotomy in Patients With Raynaud's Phenomenon | ||||
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. |
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Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Patients with Raynaud's phenomenon | ||||
Condition | 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
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
50 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | March 1, 2025 | ||||
Estimated Primary Completion Date | March 1, 2025 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria: • SPTS for other indications than RP |
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Sex/Gender |
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Ages | 16 Years and older (Child, Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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Listed Location Countries | Netherlands | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT04015193 | ||||
Other Study ID Numbers | 201900110 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | dr. DJ Mulder, University Medical Center Groningen | ||||
Study Sponsor | University Medical Center Groningen | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | University Medical Center Groningen | ||||
Verification Date | July 2019 |