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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04158661
Enrollment
248
Registered
2019-11-12
Start date
2020-04-20
Completion date
2022-06-30
Last updated
2021-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myasthenia Gravis

Keywords

Myasthenia Gravis, Robotic-assisted minimally-invasive thymectomy, Mean daily prednisone dose

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).

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.

Interventions

PROCEDUREthymectomy (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).

PROCEDUREthymectomy 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).

PROCEDUREno thymectomy (control)

routine medical care

Sponsors

NeuroCure Clinical Research Center, Charite, Berlin
CollaboratorOTHER
Department of Surgery, Charite, Berlin
CollaboratorUNKNOWN
Sana Klinikum Lichtenberg, Berlin
CollaboratorUNKNOWN
Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Mean daily prednisone dosethree years after thymectomy

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026