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出境医 / 临床实验 / Follow-up of SPTS in Patients With Raynaud's Phenomenon

Follow-up of SPTS in Patients With Raynaud's Phenomenon

Study Description
Brief Summary:

Background: Raynaud's phenomenon is a vasospasm of the extremities, leading to extensive discomfort in daily life and potentially severe ischemia. Some patients are resistant to conventional vasodilatory drug treatment. In the University Medical Center Groningen, single-port thoracoscopic sympathicotomy (SPTS) was developed. This is a new minimally invasive endoscopic technique, extensively limiting surgical burden. In many hospitals in the Netherlands, this operation is sometimes performed on patients with Raynaud's phenomenon. However, the techniques used are more invasive than the SPTS technique. Furthermore, studies on sympathectomy and sympathicotomy in Raynaud's are limited and encompass obsolete more invasive techniques. Also, it is unclear which patients would benefit the most and for how long and in which percentage of patients treatment effects persist over time. In a recent study on the new SPTS technique, it was found that one month after the procedure, the Raynaud's attacks were substantially reduced and the hand perfusion increased on the operated side. Based on these short term effects and previously reported broad experience with this technique for other indications, it is possible to offer this option to a broader range of patients with Raynaud's as a reasonable and safe treatment option. However, whether the effects persist on the long-term needs to be established.

Main research question: The aim of the study is to assess the 5 year efficacy and outcome in patients with primary and secondary Raynaud's phenomenon in whom SPTS has been performed.

Design (including population, confounders/outcomes): Patients with Raynaud's, who will undergo SPTS in patient care setting, will be included. Data from the patient file will be collected, including vascular measurements to assess hand perfusion, a Raynaud diary (Raynaud condition score, duration and frequency of the attacks), quality of life questionnaires, and adverse events.


Condition or disease Intervention/treatment
Raynaud Phenomenon Procedure: Single-port thoracoscopic sympathicotomy (patient care)

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Follow-up of Single-port Thoracoscopic Sympathicotomy in Patients With Raynaud's Phenomenon
Actual Study Start Date : March 28, 2019
Estimated Primary Completion Date : March 1, 2025
Estimated Study Completion Date : March 1, 2025
Arms and Interventions
Group/Cohort Intervention/treatment
Full responders
Full responders: no signs or symptoms of Raynaud's phenomenon (RP) in Raynaud condition score, no RP during cooling-recovery experiment.
Procedure: Single-port thoracoscopic sympathicotomy (patient care)
Single-port thoracoscopic sympathicotomy will be performed as part of patient care, data will be collected of patients undergoing this procedure

Partial responders
Partial responders: at least 25% reduction in Raynaud condition score and finger ischemia time during cooling and recovery.
Procedure: Single-port thoracoscopic sympathicotomy (patient care)
Single-port thoracoscopic sympathicotomy will be performed as part of patient care, data will be collected of patients undergoing this procedure

Non-responders
Non-responders: no or less than 25% reduction in Raynaud condition score and/or finger ischemia time during cooling and recovery.
Procedure: Single-port thoracoscopic sympathicotomy (patient care)
Single-port thoracoscopic sympathicotomy will be performed as part of patient care, data will be collected of patients undergoing this procedure

Outcome Measures
Primary Outcome Measures :
  1. Mean finger ischemia time [ Time Frame: 5 year ]
    Mean finger ischemia time of five fingers during cooling and recovery, as assessed by routine cooling and recovery photo-electric plethysmography (PPG) after 5 years of follow-up, in minutes


Secondary Outcome Measures :
  1. Mean finger ischemia time [ Time Frame: 2 year ]
    Mean finger ischemia time of five fingers during cooling and recovery, as assessed by routine cooling and recovery photo-electric plethysmography (PPG) after 2 years of follow-up, in minutes

  2. Raynaud Condition Score [ Time Frame: 1,2,3,4,5 years ]
    Mean Raynaud condition score (0-100) over a period 14 days

  3. Number of attacks [ Time Frame: 1,2,3,4,5 years ]
    Mean number of RP attacks per day over a period of 14 days

  4. Duration of attacks [ Time Frame: 1,2,3,4,5 years ]
    Mean duration of RP attacks per day over a period of 14 days in minutes

  5. SF-36 [ Time Frame: 1,2,3,4,5 years ]
    Health-related quality of life short form (SF)-36 score of 100-0

  6. HAQ [ Time Frame: 1,2,3,4,5 years ]
    (Dutch) health assessment questionnaire (HAQ) score of 0-3

  7. Capillary density [ Time Frame: 2 and 5 years ]
    Mean number of capillaries per finger of 8 fingers per 3mm

  8. Number of dilated capillaries [ Time Frame: 2 and 5 year ]
    Mean number of dilated capillaries per finger (apex width >20µm, <50µm) of 8 fingers per 3mm

  9. Number of giant capillaries [ Time Frame: 2 and 5 year ]
    Mean number of giant capillaries per finger (apex width >50µm) of 8 fingers per 3mm

  10. Capillaroscopic pattern [ Time Frame: 2 and 5 year ]
    Pattern of nailfold capillaries (normal, non-specific, early, active or late)

  11. Pulse wave velocity brachial-radial [ Time Frame: 2 and 5 years ]
    Pulse wave velocity in m/s of brachial-radial trajectory

  12. Systolic blood pressure [ Time Frame: 2 and 5 years ]
    Brachial systolic blood pressure in mmHg

  13. Diastolic blood pressure [ Time Frame: 2 and 5 years ]
    Brachial diastolic blood pressure in mmHg

  14. Mean finger blood pressure [ Time Frame: 2 and 5 years ]
    Mean finger blood pressure in mmHg of eight fingers

  15. Pulse wave velocity brachial-ulnar [ Time Frame: 2 and 5 years ]
    Pulse wave velocity in m/s of brachial-ulnar trajectory

  16. Digital ulcers [ Time Frame: 1,2,3,4,5 years ]
    Incidence of digital ulcers (yes/no)

  17. Compensatory sweating [ Time Frame: 1,2,3,4,5 years ]
    Compensatory sweating (yes/no)

  18. Wound infection or other adverse events [ Time Frame: 2 weeks, 1,2,3,4,5 years ]
    Occurrence of wound infection or other adverse events potentially related to SPTS


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Raynaud's phenomenon
Criteria

Inclusion Criteria:

  • Raynaud's phenomenon of the hands
  • Scheduled SPTS as treatment for RP
  • Age ≥ 16 years

Exclusion Criteria:

• SPTS for other indications than RP

Contacts and Locations

Contacts
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Contact: Douwe J Mulder, MD, PhD +31503612943 d.j.mulder@umcg.nl

Locations
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Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9700 RB
Contact: Douwe J Mulder, MD, PhD    +31-50-3612350    d.j.mulder@umcg.nl   
Principal Investigator: Douwe J. Mulder, MD, PhD         
Sub-Investigator: Anniek M. van Roon         
Sub-Investigator: Michiel Kuijpers, MD         
Sponsors and Collaborators
University Medical Center Groningen
Investigators
Layout table for investigator information
Principal Investigator: Douwe J Mulder, MD, PhD University of Groninge, University Medical Center Groningen
Tracking Information
First Submitted Date April 1, 2019
First Posted Date July 10, 2019
Last Update Posted Date July 10, 2019
Actual Study Start Date March 28, 2019
Estimated Primary Completion Date March 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 8, 2019)
Mean finger ischemia time [ Time Frame: 5 year ]
Mean finger ischemia time of five fingers during cooling and recovery, as assessed by routine cooling and recovery photo-electric plethysmography (PPG) after 5 years of follow-up, in minutes
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 8, 2019)
  • Mean finger ischemia time [ Time Frame: 2 year ]
    Mean finger ischemia time of five fingers during cooling and recovery, as assessed by routine cooling and recovery photo-electric plethysmography (PPG) after 2 years of follow-up, in minutes
  • Raynaud Condition Score [ Time Frame: 1,2,3,4,5 years ]
    Mean Raynaud condition score (0-100) over a period 14 days
  • Number of attacks [ Time Frame: 1,2,3,4,5 years ]
    Mean number of RP attacks per day over a period of 14 days
  • Duration of attacks [ Time Frame: 1,2,3,4,5 years ]
    Mean duration of RP attacks per day over a period of 14 days in minutes
  • SF-36 [ Time Frame: 1,2,3,4,5 years ]
    Health-related quality of life short form (SF)-36 score of 100-0
  • HAQ [ Time Frame: 1,2,3,4,5 years ]
    (Dutch) health assessment questionnaire (HAQ) score of 0-3
  • Capillary density [ Time Frame: 2 and 5 years ]
    Mean number of capillaries per finger of 8 fingers per 3mm
  • Number of dilated capillaries [ Time Frame: 2 and 5 year ]
    Mean number of dilated capillaries per finger (apex width >20µm, <50µm) of 8 fingers per 3mm
  • Number of giant capillaries [ Time Frame: 2 and 5 year ]
    Mean number of giant capillaries per finger (apex width >50µm) of 8 fingers per 3mm
  • Capillaroscopic pattern [ Time Frame: 2 and 5 year ]
    Pattern of nailfold capillaries (normal, non-specific, early, active or late)
  • Pulse wave velocity brachial-radial [ Time Frame: 2 and 5 years ]
    Pulse wave velocity in m/s of brachial-radial trajectory
  • Systolic blood pressure [ Time Frame: 2 and 5 years ]
    Brachial systolic blood pressure in mmHg
  • Diastolic blood pressure [ Time Frame: 2 and 5 years ]
    Brachial diastolic blood pressure in mmHg
  • Mean finger blood pressure [ Time Frame: 2 and 5 years ]
    Mean finger blood pressure in mmHg of eight fingers
  • Pulse wave velocity brachial-ulnar [ Time Frame: 2 and 5 years ]
    Pulse wave velocity in m/s of brachial-ulnar trajectory
  • Digital ulcers [ Time Frame: 1,2,3,4,5 years ]
    Incidence of digital ulcers (yes/no)
  • Compensatory sweating [ Time Frame: 1,2,3,4,5 years ]
    Compensatory sweating (yes/no)
  • Wound infection or other adverse events [ Time Frame: 2 weeks, 1,2,3,4,5 years ]
    Occurrence of wound infection or other adverse events potentially related to SPTS
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Follow-up of SPTS in Patients With Raynaud's Phenomenon
Official Title Follow-up of Single-port Thoracoscopic Sympathicotomy in Patients With Raynaud's Phenomenon
Brief Summary

Background: Raynaud's phenomenon is a vasospasm of the extremities, leading to extensive discomfort in daily life and potentially severe ischemia. Some patients are resistant to conventional vasodilatory drug treatment. In the University Medical Center Groningen, single-port thoracoscopic sympathicotomy (SPTS) was developed. This is a new minimally invasive endoscopic technique, extensively limiting surgical burden. In many hospitals in the Netherlands, this operation is sometimes performed on patients with Raynaud's phenomenon. However, the techniques used are more invasive than the SPTS technique. Furthermore, studies on sympathectomy and sympathicotomy in Raynaud's are limited and encompass obsolete more invasive techniques. Also, it is unclear which patients would benefit the most and for how long and in which percentage of patients treatment effects persist over time. In a recent study on the new SPTS technique, it was found that one month after the procedure, the Raynaud's attacks were substantially reduced and the hand perfusion increased on the operated side. Based on these short term effects and previously reported broad experience with this technique for other indications, it is possible to offer this option to a broader range of patients with Raynaud's as a reasonable and safe treatment option. However, whether the effects persist on the long-term needs to be established.

Main research question: The aim of the study is to assess the 5 year efficacy and outcome in patients with primary and secondary Raynaud's phenomenon in whom SPTS has been performed.

Design (including population, confounders/outcomes): Patients with Raynaud's, who will undergo SPTS in patient care setting, will be included. Data from the patient file will be collected, including vascular measurements to assess hand perfusion, a Raynaud diary (Raynaud condition score, duration and frequency of the attacks), quality of life questionnaires, and adverse events.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with Raynaud's phenomenon
Condition Raynaud Phenomenon
Intervention Procedure: Single-port thoracoscopic sympathicotomy (patient care)
Single-port thoracoscopic sympathicotomy will be performed as part of patient care, data will be collected of patients undergoing this procedure
Study Groups/Cohorts
  • Full responders
    Full responders: no signs or symptoms of Raynaud's phenomenon (RP) in Raynaud condition score, no RP during cooling-recovery experiment.
    Intervention: Procedure: Single-port thoracoscopic sympathicotomy (patient care)
  • Partial responders
    Partial responders: at least 25% reduction in Raynaud condition score and finger ischemia time during cooling and recovery.
    Intervention: Procedure: Single-port thoracoscopic sympathicotomy (patient care)
  • Non-responders
    Non-responders: no or less than 25% reduction in Raynaud condition score and/or finger ischemia time during cooling and recovery.
    Intervention: Procedure: Single-port thoracoscopic sympathicotomy (patient care)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 8, 2019)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 1, 2025
Estimated Primary Completion Date March 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Raynaud's phenomenon of the hands
  • Scheduled SPTS as treatment for RP
  • Age ≥ 16 years

Exclusion Criteria:

• SPTS for other indications than RP

Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Douwe J Mulder, MD, PhD +31503612943 d.j.mulder@umcg.nl
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT04015193
Other Study ID Numbers 201900110
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party dr. DJ Mulder, University Medical Center Groningen
Study Sponsor University Medical Center Groningen
Collaborators Not Provided
Investigators
Principal Investigator: Douwe J Mulder, MD, PhD University of Groninge, University Medical Center Groningen
PRS Account University Medical Center Groningen
Verification Date July 2019