Myasthenia GravisNCT04158661
Influence of Minimally Invasive Thymectomy on the Subsequent Clinical Course of Myasthenia Gravis
An observational study of Myasthenia Gravis, run by Charite University, Berlin, Germany at 3 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myasthenia Gravis
- What is being tested?
- thymectomy (robotic-assisted thoracoscopic, minimally-invasive thymectomy) and thymectomy by means of median sternotomy (transsternal)
- Type of treatment
- Surgery or procedure
- How many people
- 248 participants
- Where
- 3 sitesGermany
- Study dates
- 20 Apr 2020to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Patients with Myasthenia Gravis
- Age ≥18 years
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Sana Klinikum Lichtenberg
Berlin
Department of Surgery Charité University
Mitte
NeuroCure Clinical Research Center (NCRC), Charité University, Berlin
Mitte
About this study
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).
Read the 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.
- Conditions
- Myasthenia Gravis
- Being tested
- thymectomy (robotic-assisted thoracoscopic, minimally-invasive thymectomy), thymectomy by means of median sternotomy (transsternal), no thymectomy (control)
- Keywords
- Myasthenia Gravis, Robotic-assisted minimally-invasive thymectomy, Mean daily prednisone dose
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thymectomy (robotic-assisted thoracoscopic, minimally-invasive thymectomy)Procedure or surgery
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).
thymectomy by means of median sternotomy (transsternal)Procedure or surgery
with a goal of an en bloc resection of all mediastinal tissue that could anatomically contain gross or microscopic thymus (or both).
no thymectomy (control)Procedure or surgery
routine medical care
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: thymectomy (robotic-assisted thoracoscopic, minimally-invasive thymectomy) | |
| 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 Receives: Procedure: no thymectomy (control) | |
| MGTX-group ("historical control group") | from MGTX-trial ("Randomized Trial of Thymectomy in Myasthenia Gravis") Receives: Procedure: thymectomy by means of median sternotomy (transsternal) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean daily prednisone dose
Measured: three years after thymectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start20 Apr 2020
- Primary completion30 Nov 2020
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myasthenia GravisStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- NeuroCure Clinical Research Center, Charite, Berlin, Department of Surgery, Charite, Berlin, Sana Klinikum Lichtenberg, Berlin
- Responsible party
- Principal investigator, Andreas Meisel, Charite University, Berlin, Germany
- Investigators
- Andreas Meisel, Prof. Dr. med., Principal investigator, Charité University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04158661
- Sponsor's protocol ID
- Mya-Thymektomie
- Status last verified
- Sep 2021
- First submitted
- 7 Nov 2019
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27509100
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Minimally Invasive Thymectomy on the Subsequent Clinical Course of Myasthenia Gravis
- ClinicalTrials.gov ID
- NCT04158661
- Acronym / sponsor ID
- Mya-Thymektomie
- Conditions
- Myasthenia Gravis
- Keywords
- Myasthenia Gravis, Robotic-assisted minimally-invasive thymectomy, Mean daily prednisone dose
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- NeuroCure Clinical Research Center, Charite, Berlin, Department of Surgery, Charite, Berlin, Sana Klinikum Lichtenberg, Berlin
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 12 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tmin-group | – | Procedure: thymectomy (robotic-assisted thoracoscopic, minimally-invasive thymectomy)* 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 | – | Procedure: no thymectomy (control)* 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") | – | Procedure: thymectomy by means of median sternotomy (transsternal)from MGTX-trial ("Randomized Trial of Thymectomy in Myasthenia Gravis") |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Patients with Myasthenia Gravis
- Age ≥18 years
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Procedure or surgery | Tmin-group |
| 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). | Procedure or surgery | MGTX-group ("historical control group") |
| no thymectomy (control)routine medical care | Procedure or surgery | T0-group |
Primary outcome
Mean daily prednisone dose
Time frame: three years after thymectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
- Background: PubMed 27509100Wolfe 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Meisel, Prof. Dr. med. principal investigator
Charité University, Berlin, Germany
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myasthenia Gravis, run by Charite University, Berlin, Germany at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean daily prednisone dose (time frame: three years after thymectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04158661, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2021.