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

• Sponsor: Charite University, Berlin, Germany (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04158661
• Collaborator: NeuroCure Clinical Research Center, Charite, Berlin (Other), Department of Surgery, Charite, Berlin (Other), Sana Klinikum Lichtenberg, Berlin (Other)
• Enrollment: 248
• Locations: 3
• Anticipated Duration (Months): 26.3
• Patients Per Site: 82.7
• Patients Per Site Per Month: 3.1

Study Details

Study Description

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	Phase
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.

Study Design

• Study Type: Observational
• Actual Enrollment: 248 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: Apr 20, 2020
• Actual Primary Completion Date: Nov 30, 2020
• Anticipated Study Completion Date: Jun 30, 2022

Arms and Interventions

Arm	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).

Outcome Measures

Primary Outcome Measures

1. Mean daily prednisone dose [three years after thymectomy]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Surgery Charité University	Berlin-Mitte		Germany
2	NeuroCure Clinical Research Center (NCRC), Charité University, Berlin	Berlin-Mitte		Germany
3	Sana Klinikum Lichtenberg	Berlin		Germany

Sponsors and Collaborators

• Charite University, Berlin, Germany
• NeuroCure Clinical Research Center, Charite, Berlin
• Department of Surgery, Charite, Berlin
• Sana Klinikum Lichtenberg, Berlin

Investigators

• Principal Investigator: Andreas Meisel, Prof. Dr. med., Charité University, Berlin, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

• Wolfe GI, Kaminski HJ, Aban IB, Minisman G, Kuo HC, Marx A, Ströbel 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. Erratum in: N Engl J Med. 2017 May 25;376(21):2097. [Dosage error in article text].

• Responsible Party: Andreas Meisel, Prof. Dr. med., Charite University, Berlin, Germany
• ClinicalTrials.gov Identifier: NCT04158661
• Other Study ID Numbers: Mya-Thymektomie
• First Posted: Nov 12, 2019
• Last Update Posted: Sep 24, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Andreas Meisel, Prof. Dr. med., Charite University, Berlin, Germany: Myasthenia Gravis; Robotic-assisted minimally-invasive thymectomy; Mean daily prednisone dose
• Additional relevant MeSH terms: Myasthenia Gravis; Muscle Weakness

Study Results

No Results Posted as of Sep 24, 2021