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

NCT ID: NCT04158661

Last Updated: 2021-09-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 248 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-20
• Study Completion Date: 2022-06-30

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.

Conditions

Myasthenia Gravis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Study Groups

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

thymectomy (robotic-assisted thoracoscopic, minimally-invasive thymectomy)

Intervention Type: PROCEDURE

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

no thymectomy (control)

Intervention Type: PROCEDURE

routine medical care

MGTX-group ("historical control group")

from MGTX-trial ("Randomized Trial of Thymectomy in Myasthenia Gravis")

thymectomy by means of median sternotomy (transsternal)

Intervention Type: PROCEDURE

with a goal of an en bloc resection of all mediastinal tissue that could anatomically contain gross or microscopic thymus (or both).

Interventions

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).

Intervention Type: 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).

Intervention Type: PROCEDURE

no thymectomy (control)

routine medical care

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NeuroCure Clinical Research Center, Charite, Berlin

OTHER

Sponsor Role: collaborator

Department of Surgery, Charite, Berlin

UNKNOWN

Sponsor Role: collaborator

Sana Klinikum Lichtenberg, Berlin

UNKNOWN

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Andreas Meisel

Prof. Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andreas Meisel, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Charité University, Berlin, Germany

Locations

Sana Klinikum Lichtenberg

Berlin, , Germany

Department of Surgery Charité University

Mitte, , Germany

NeuroCure Clinical Research Center (NCRC), Charité University, Berlin

Mitte, , Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 27509100 (View on PubMed)

Other Identifiers

Mya-Thymektomie

Identifier Type: -

Identifier Source: org_study_id