Single-port Thoracoscopic Sympathicotomy for Treatment of Raynaud's Phenomenon, a Feasibility Study
Primary Purpose
Raynauds
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Sympathicotomy R3
Sponsored by
About this trial
This is an interventional treatment trial for Raynauds
Eligibility Criteria
Inclusion Criteria:
- Severe form of SRP, defined as clinical need of prostacyclin analogue infusions and/or bosentan having been given in the preceding 2 years, without satisfying result.
- No concurrent neurological disease
Exclusion Criteria:
- Known Chronic Obstructive Pulmonary Disease > Gold class 1.
- History of smoking > 20 pack years, due to higher risk of complications following unilateral lung- deflation and re-insufflation.
- Documented substance addiction.
- Signs/symptoms of macrovascular disease, or abnormalities on Doppler/duplex studies
- Other signs/symptoms of systemic autoimmune disease
- Severe concomitant diseases of the liver (eg Liver Function tests > three times the upper limit of normal), kidneys (creatinine > 160 mol/l), heart (including history of myocardial infarction, heart failure or angina pectoris), lung, blood, endocrine system, gastrointestinal system, Central Nervous System.
- Previous intra-thoracic pleural drainage.
- Previous thoracic surgery (including sternotomy).
- Gross pulmonary or pleural abnormalities on chest X-ray.
- Pregnancy.
- Unsuitable anatomy (e.g. due to severe physical malformations).
Sites / Locations
- University Medical Centre Groningen
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All
Arm Description
All patient will undergo a unilateral sympathicotomy R3. After this left and right will be compared
Outcomes
Primary Outcome Measures
Cooling plethysmography, nailfold capillary microscopy
Change from baseline in microvascular circulation at 1 month
Cooling plethysmography, nailfold capillary microscopy
Change from baseline in microvascular circulation at 6 months
Secondary Outcome Measures
Quality of Life
Change from baseline in quality of life as measured by Short Form 36 (SF36) at 1, 6 and 12 months
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02680509
Brief Title
Single-port Thoracoscopic Sympathicotomy for Treatment of Raynaud's Phenomenon, a Feasibility Study
Official Title
Single-port Thoracoscopic Sympathicotomy for Treatment of Raynaud's Phenomenon, a Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
February 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michiel Kuijpers
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal is to investigate the effect of a single-port R3 sympathicotomy on microvascular circulation in the affected fingers. This effect is analysed by performing cooling plethysmography and nailfold capillary microscopy bilaterally, following a unilateral, single-port thoracoscopic sympathicotomy.
Detailed Description
Raynaud's phenomenon is discoloration, discomfort and numbness or pain in the fingers and toes as a result of excessively reduced blood flow due to sympathetic induced vasospasms, in response to a change in temperature or emotional stress. It usually affects multiple fingers of both hands and comes in frequent attacks, with little or no discomfort in between them. Current treatment consists of stepped-care, including preventive measures optimizing digital blood flow, oral and intravenous medical therapy aimed at improving microvascular circulation, surgical neuromodulation to achieve vasodilatation and neurostimulation.
While surgical sympathectomy is an established treatment of Raynaud's phenomenon, its more invasive nature has prevented widespread application as an initial therapy. After introduction of minimally invasive surgical techniques in recent years, the investigators have further optimized the endoscopic sympathicotomy procedure performed on hyperhidrosis patients, now needing only a single 1 cm port for a detailed, panoramic view of the sympathetic chain (1). This minimal invasive technique has proven to be a safe, efficient and reproducible treatment for several indications and seems also suitable for Raynaud's patients.
In this feasibility study, the researchers want to investigate the effect of a single-port R3 sympathicotomy on microvascular circulation in the affected fingers. This effect is analysed by performing cooling plethysmography and nailfold capillary microscopy bilaterally, following a unilateral, single-port thoracoscopic sympathicotomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Raynauds
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
All
Arm Type
Experimental
Arm Description
All patient will undergo a unilateral sympathicotomy R3. After this left and right will be compared
Intervention Type
Procedure
Intervention Name(s)
Sympathicotomy R3
Intervention Description
sympathicotomy R3 consists of transecting the sympathetic chain at the third costal level, cranial of the ganglia, leaving the ganglia themselves untouched
Primary Outcome Measure Information:
Title
Cooling plethysmography, nailfold capillary microscopy
Description
Change from baseline in microvascular circulation at 1 month
Time Frame
1 month follow up
Title
Cooling plethysmography, nailfold capillary microscopy
Description
Change from baseline in microvascular circulation at 6 months
Time Frame
6 month follow up
Secondary Outcome Measure Information:
Title
Quality of Life
Description
Change from baseline in quality of life as measured by Short Form 36 (SF36) at 1, 6 and 12 months
Time Frame
1, 6 and 12 months of follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Severe form of SRP, defined as clinical need of prostacyclin analogue infusions and/or bosentan having been given in the preceding 2 years, without satisfying result.
No concurrent neurological disease
Exclusion Criteria:
Known Chronic Obstructive Pulmonary Disease > Gold class 1.
History of smoking > 20 pack years, due to higher risk of complications following unilateral lung- deflation and re-insufflation.
Documented substance addiction.
Signs/symptoms of macrovascular disease, or abnormalities on Doppler/duplex studies
Other signs/symptoms of systemic autoimmune disease
Severe concomitant diseases of the liver (eg Liver Function tests > three times the upper limit of normal), kidneys (creatinine > 160 mol/l), heart (including history of myocardial infarction, heart failure or angina pectoris), lung, blood, endocrine system, gastrointestinal system, Central Nervous System.
Previous intra-thoracic pleural drainage.
Previous thoracic surgery (including sternotomy).
Gross pulmonary or pleural abnormalities on chest X-ray.
Pregnancy.
Unsuitable anatomy (e.g. due to severe physical malformations).
Facility Information:
Facility Name
University Medical Centre Groningen
City
Groningen
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
35944349
Citation
Kuijpers M, van de Zande SC, van Roon AM, van Roon AM, Stel AJ, Smit AJ, Bouma W, DeJongste MJL, Mariani MA, Klinkenberg TJ, Mulder DJ. Treatment of resistant Raynaud's phenomenon with single-port thoracoscopic sympathicotomy: One-year follow-up. Semin Arthritis Rheum. 2022 Oct;56:152065. doi: 10.1016/j.semarthrit.2022.152065. Epub 2022 Jul 9.
Results Reference
derived
PubMed Identifier
31529103
Citation
van Roon AM, Kuijpers M, van de Zande SC, Abdulle AE, van Roon AM, Bos R, Bouma W, Klinkenberg TJ, Bootsma H, DeJongste MJL, Mariani MA, Smit AJ, Mulder DJ. Treatment of resistant Raynaud's phenomenon with single-port thoracoscopic sympathicotomy: a novel minimally invasive endoscopic technique. Rheumatology (Oxford). 2020 May 1;59(5):1021-1025. doi: 10.1093/rheumatology/kez386.
Results Reference
derived
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Single-port Thoracoscopic Sympathicotomy for Treatment of Raynaud's Phenomenon, a Feasibility Study
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