Skip to main content
OpenTrials
Completed

NCT Number: NCT02680509

Single-port Thoracoscopic Sympathicotomy for Treatment of Raynaud's Phenomenon, a Feasibility Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Centre Groningen

Groningen, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Sympathicotomy R3

Procedure

sympathicotomy R3 consists of transecting the sympathetic chain at the third costal level, cranial of the ganglia, leaving the ganglia themselves untouched

Primary outcomes

  1. Cooling plethysmography, nailfold capillary microscopy

    Time frame: 1 month follow up

    Change from baseline in microvascular circulation at 1 month

  2. Cooling plethysmography, nailfold capillary microscopy

    Time frame: 6 month follow up

    Change from baseline in microvascular circulation at 6 months

Secondary outcomes

  1. Quality of Life

    Time frame: 1, 6 and 12 months of follow-up

    Change from baseline in quality of life as measured by Short Form 36 (SF36) at 1, 6 and 12 months

Sponsors and collaborators

Lead sponsor

Michiel Kuijpers

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 11, 2016
Registry last updated
Mar 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.