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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
Michiel Kuijpers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Raynauds

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
August 25, 2015
Last Updated
February 28, 2019
Sponsor
Michiel Kuijpers
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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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