Clinical trial · Observational
Influence of Minimally Invasive Thymectomy on the Subsequent Clinical Course of Myasthenia Gravis
NCT04158661CI-TRIAL-00054063unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myasthenia Gravis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| no thymectomy (control) | Procedure | — | UNRESOLVED |
| thymectomy by means of median sternotomy (transsternal) | Procedure | — | UNRESOLVED |
| thymectomy (robotic-assisted thoracoscopic, minimally-invasive thymectomy) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Tmin-group
- description
- * 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
- interventionNames
- Procedure: thymectomy (robotic-assisted thoracoscopic, minimally-invasive thymectomy)
- label
- T0-group
- description
- * 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
- interventionNames
- Procedure: no thymectomy (control)
- label
- MGTX-group ("historical control group")
- description
- from MGTX-trial ("Randomized Trial of Thymectomy in Myasthenia Gravis")
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDWolfe 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 27509100