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Influence of Minimally Invasive Thymectomy on the Subsequent Clinical Course of Myasthenia Gravis

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ClinicalTrials.gov Identifier: NCT04158661
Recruitment Status : Recruiting
First Posted : November 12, 2019
Last Update Posted : July 9, 2020
Sponsor:
Collaborators:
NeuroCure Clinical Research Center, Charite, Berlin
Department of Surgery, Charite, Berlin
Sana Klinikum Lichtenberg, Berlin
Information provided by (Responsible Party):
Andreas Meisel, Charite University, Berlin, Germany

Brief Summary:

The aim of this study is to investigate whether minimally invasive thymectomy achieves comparable efficacy and safety results compared to open thymectomy in patients with myasthenia gravis. The planned investigation is a multicenter observational study based on retrospective (present patient data) and prospective data (questionable outcome data).

Primary hypothesis: Minimally invasive thymectomy is not inferior to open thymectomy in terms of efficacy and safety (non-inferiority study).


Condition or disease Intervention/treatment
Myasthenia Gravis Procedure: thymectomy (robotic-assisted thoracoscopic, minimally-invasive thymectomy) Procedure: thymectomy by means of median sternotomy (transsternal) Procedure: no thymectomy (control)

Detailed Description:

Based on large cohort studies of the last decades, the thymectomy has become a central component of the immunomodulating therapy in MG patients without thymoma detection. Because randomized studies were missing, remained a residual uncertainty on the importance of Thymectomy. In the study "Randomized Trial of Thymectomy in Myasthenia Gravis" (MGTX-study) published 2016 the effectiveness of thymectomy by patients without thymoma detection has been indisputable confirmed. A significant improvement of the patient`s complaints and the reduction of the immunosuppressive drugs were particularly evident by early onset MG (EOMG) two to three years after performing a complete resection of the thymic tissue.

While the MGTX study (with an open operative procedure) was being done, the minimally-invasive thymectomy has gained more and more acceptance. From a surgical point of view, the minimally invasive thoracoscopic procedure represents a gentler alternative. According to the momentaneous clinical-scientific point of view, further studies are necessary to compare both procedures. Furthermore, the MGTX study included only patients with generalized MG and positive anti-Acetylcholine Receptor (AChR)-antibodies, who were younger than 65 years, so that the relevance of thymectomy in other important subgroups, such as late onset MG (LOMG), the ocular MG (OMG), as well as the patients without detected antibodies (seronegative MG patients), who represent about 10 % of whole population of MG patients, is still not clear.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: Influence of Minimally Invasive Thymectomy on the Subsequent Clinical Course of Myasthenia Gravis
Actual Study Start Date : April 20, 2020
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Tmin-group
  • confirmed seropositive ocular or generalized MG [detection of antibodies (Abs) targeting the AChR, muscle‐specific tyrosine kinase (MuSK) or Titin] or seronegative ocular or generalized MG
  • age ≥ 18 years
  • thymectomy ≥ three years
Procedure: thymectomy (robotic-assisted thoracoscopic, minimally-invasive thymectomy)
preferring one unilateral access and placing three trocars between 3rd and 5th intercostal space in a triangular configuration, with a goal of an en bloc resection of all mediastinal tissue that could anatomically contain gross or microscopic thymus (or both).

T0-group
  • confirmed seropositive ocular or generalized MG [detection of antibodies (Abs) targeting the AChR, muscle‐specific tyrosine kinase (MuSK) or Titin] or seronegative ocular or generalized MG
  • a very long disease history OR
  • age ≥ 18 years
  • rejecting a thymectomy or have contraindications for thymectomy
Procedure: no thymectomy (control)
routine medical care

MGTX-group ("historical control group")
from MGTX-trial ("Randomized Trial of Thymectomy in Myasthenia Gravis")
Procedure: thymectomy by means of median sternotomy (transsternal)
with a goal of an en bloc resection of all mediastinal tissue that could anatomically contain gross or microscopic thymus (or both).




Primary Outcome Measures :
  1. Mean daily prednisone dose [ Time Frame: three years after thymectomy ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with confirmed diagnosis of myasthenia gravis by:

  • typical clinical features AND
  • antibody diagnostic AND
  • positive edrophonium test OR
  • abnormal repetitive nerve stimulation OR
  • abnormal single-fiber electromyography.

Myasthenia Gravis Foundation of America clinical classification (MGFA classification) of I to V was accepted (class I indicates weakness only in ocular muscles, class II mild generalized disease, class III moderate generalized disease, class IV severe generalized disease and class V a crisis requiring Intubation)

Participants could be taking appropriate anticholinesterase therapy with or without oral glucocorticoids

Criteria

Inclusion Criteria:

  • Patients with Myasthenia Gravis
  • Age ≥18 years

Exclusion Criteria:

  • a proper communication with the patient is not possible
  • an informed consent could not be signed
  • a patient reject a participation or requires breaking up

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158661


Contacts
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Contact: Andreas Meisel, Prof. Dr. med. +49 30 450 560026 andreas.meisel@charite.de
Contact: Frauke Stascheit, Dr. med. +49 30 450 539723 frauke.stascheit@charite.de

Locations
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Germany
Department of Surgery Charité University Not yet recruiting
Berlin-Mitte, Germany
Contact: Jens-Carsten Rückert, Prof. Dr. med.    +49 30 450 522 099    jens-c.rueckert@charite.de   
NeuroCure Clinical Research Center (NCRC), Charité University, Berlin Recruiting
Berlin-Mitte, Germany
Contact: Andreas Meisel, Prof. Dr. med.    +49 30 450 560026    andreas.meisel@charite.de   
Contact: Frauke Stascheit, Dr. med.    +49 30 450 539723    frauke.stascheit@charite.de   
Sana Klinikum Lichtenberg Not yet recruiting
Berlin, Germany
Contact: Gero Bauer, Dr. med.    +49 30 450 622 209    gero.bauer@charite.de   
Sponsors and Collaborators
Charite University, Berlin, Germany
NeuroCure Clinical Research Center, Charite, Berlin
Department of Surgery, Charite, Berlin
Sana Klinikum Lichtenberg, Berlin
Investigators
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Principal Investigator: Andreas Meisel, Prof. Dr. med. Charité University, Berlin, Germany
Publications:
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Responsible Party: Andreas Meisel, Prof. Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT04158661    
Other Study ID Numbers: Mya-Thymektomie
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andreas Meisel, Charite University, Berlin, Germany:
Myasthenia Gravis
Robotic-assisted minimally-invasive thymectomy
Mean daily prednisone dose
Additional relevant MeSH terms:
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Muscle Weakness
Myasthenia Gravis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Autoimmune Diseases of the Nervous System
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases