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临床试验/NCT02680509
NCT02680509已完成不适用

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

Michiel Kuijpers1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2016年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
8
试验地点
1
主要终点
Cooling plethysmography, nailfold capillary microscopy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Known Chronic Obstructive Pulmonary Disease > Gold class
  • 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).

研究组 & 干预措施

All

Experimental

All patient will undergo a unilateral sympathicotomy R3. After this left and right will be compared

干预措施: Sympathicotomy R3 (Procedure)

结局指标

主要结局

Cooling plethysmography, nailfold capillary microscopy

时间窗: 6 month follow up

Change from baseline in microvascular circulation at 6 months

次要结局

  • Quality of Life(1, 6 and 12 months of follow-up)

研究者

发起方
Michiel Kuijpers
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Michiel Kuijpers

MD

University of Groningen

研究点 (1)

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