Influence of Minimally Invasive Thymectomy on the Subsequent Clinical Course of Myasthenia Gravis
1 other identifier
observational
248
1 country
3
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2020
Typical duration for all trials
3 active sites
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
November 7, 2019
CompletedFirst Posted
Study publicly available on registry
November 12, 2019
CompletedStudy Start
First participant enrolled
April 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedSeptember 24, 2021
September 1, 2021
7 months
November 7, 2019
September 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean daily prednisone dose
three years after thymectomy
Study Arms (3)
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
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
MGTX-group ("historical control group")
from MGTX-trial ("Randomized Trial of Thymectomy in Myasthenia Gravis")
Interventions
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).
with a goal of an en bloc resection of all mediastinal tissue that could anatomically contain gross or microscopic thymus (or both).
Eligibility Criteria
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
You may qualify if:
- Patients with Myasthenia Gravis
- Age ≥18 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Charite University, Berlin, Germanylead
- NeuroCure Clinical Research Center, Charite, Berlincollaborator
- Department of Surgery, Charite, Berlincollaborator
- Sana Klinikum Lichtenberg, Berlincollaborator
Study Sites (3)
Sana Klinikum Lichtenberg
Berlin, Germany
Department of Surgery Charité University
Mitte, Germany
NeuroCure Clinical Research Center (NCRC), Charité University, Berlin
Mitte, Germany
Related Publications (1)
Wolfe GI, Kaminski HJ, Aban IB, Minisman G, Kuo HC, Marx A, Strobel P, Mazia C, Oger J, Cea JG, Heckmann JM, Evoli A, Nix W, Ciafaloni E, Antonini G, Witoonpanich R, King JO, Beydoun SR, Chalk CH, Barboi AC, Amato AA, Shaibani AI, Katirji B, Lecky BR, Buckley C, Vincent A, Dias-Tosta E, Yoshikawa H, Waddington-Cruz M, Pulley MT, Rivner MH, Kostera-Pruszczyk A, Pascuzzi RM, Jackson CE, Garcia Ramos GS, Verschuuren JJ, Massey JM, Kissel JT, Werneck LC, Benatar M, Barohn RJ, Tandan R, Mozaffar T, Conwit R, Odenkirchen J, Sonett JR, Jaretzki A 3rd, Newsom-Davis J, Cutter GR; MGTX Study Group. Randomized Trial of Thymectomy in Myasthenia Gravis. N Engl J Med. 2016 Aug 11;375(6):511-22. doi: 10.1056/NEJMoa1602489.
PMID: 27509100BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andreas Meisel, Prof. Dr. med.
Charité University, Berlin, Germany
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. med.
Study Record Dates
First Submitted
November 7, 2019
First Posted
November 12, 2019
Study Start
April 20, 2020
Primary Completion
November 30, 2020
Study Completion
June 30, 2022
Last Updated
September 24, 2021
Record last verified: 2021-09