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

Myasthenia Gravis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04158661
• Other study ID #: Mya-Thymektomie
• Status: Active, not recruiting
• Start date: April 20, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: September 2021
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 248
• Est. completion date: June 30, 2022
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Muscle Weakness
• Myasthenia Gravis

Intervention

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).
• 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).
• no thymectomy (control)
routine medical care

Locations

Country	Name	City	State
Germany	Sana Klinikum Lichtenberg	Berlin
Germany	Department of Surgery Charité University	Berlin-Mitte
Germany	NeuroCure Clinical Research Center (NCRC), Charité University, Berlin	Berlin-Mitte

Sponsors (4)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Department of Surgery, Charite, Berlin, NeuroCure Clinical Research Center, Charite, Berlin, Sana Klinikum Lichtenberg, Berlin

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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]. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean daily prednisone dose		three years after thymectomy