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

September 23, 2021 updated by: Andreas Meisel, Charite University, Berlin, Germany

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

248

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with confirmed diagnosis of myasthenia gravis by:

  • typical clinical features AND
  • antibody diagnostic AND
  • positive edrophonium test OR
  • abnormal repetitive nerve stimulation OR
  • abnormal single-fiber electromyography.

Myasthenia Gravis Foundation of America clinical classification (MGFA classification) of I to V was accepted (class I indicates weakness only in ocular muscles, class II mild generalized disease, class III moderate generalized disease, class IV severe generalized disease and class V a crisis requiring Intubation)

Participants could be taking appropriate anticholinesterase therapy with or without oral glucocorticoids

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean daily prednisone dose
Time Frame: three years after thymectomy
three years after thymectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2020

Primary Completion (Actual)

November 30, 2020

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

November 7, 2019

First Submitted That Met QC Criteria

November 7, 2019

First Posted (Actual)

November 12, 2019

Study Record Updates

Last Update Posted (Actual)

September 24, 2021

Last Update Submitted That Met QC Criteria

September 23, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mya-Thymektomie

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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