NCT02680509

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 11, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

March 4, 2019

Status Verified

February 1, 2019

Enrollment Period

3 years

First QC Date

August 25, 2015

Last Update Submit

February 28, 2019

Conditions

Raynauds

Outcome Measures

Primary Outcomes (2)

  • Cooling plethysmography, nailfold capillary microscopy

    Change from baseline in microvascular circulation at 1 month

    1 month follow up

  • Cooling plethysmography, nailfold capillary microscopy

    Change from baseline in microvascular circulation at 6 months

    6 month follow up

Secondary Outcomes (1)

  • Quality of Life

    1, 6 and 12 months of follow-up

Study Arms (1)

All

EXPERIMENTAL

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

Procedure: Sympathicotomy R3

Interventions

Sympathicotomy R3PROCEDURE

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

All

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Groningen

Groningen, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 35944349DERIVED

  • 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.

    PMID: 31529103DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 25, 2015

First Posted

February 11, 2016

Study Start

February 1, 2016

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

March 4, 2019

Record last verified: 2019-02

Locations

NL(1)