- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03825185
Transsternal Versus Transcervical Thymectomy
Transsternal Versus Transcervical Thymectomy for the Management of Myasthenia Gravis: A Randomized Controlled Trial With a Mean Follow-up of 10 Years
Objective: To comparatively analyze long-term results and complications of transcervical (TCT) and transsternal thymectomy (TST) in a randomized controlled trial with a mean follow-up of ten years.
Results: Outcomes 10 years after surgery by MGFA post-intervention status showed that complete stable remission was achieved in 8 (21.6%) patients of the TCT group, and in 20 patients (55.5%) of the TST group.
Conclusions: Transcervical and transsternal thymectomy are safe and result in significant improvement of patients with Myasthenia Gravis. TST has superior results in terms of complete stable remission at 10 years.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: Thymectomy is an effective treatment for Myasthenia Gravis in the adult population. Surgical removal of the thymus can be performed through several approaches. Comparison of the most commonly used surgical techniques through randomized control trials with long-term follow-up is scarce.
Objective: To comparatively analyze long-term results and complications of transcervical (TCT) and transsternal thymectomy (TST) in a randomized controlled trial with a mean follow-up of ten years.
Results: A total of 100 patients were randomized to transsternal thymectomy (50), and transcervical procedure (50). There were not significant differences in the demographic characteristics, MGFA clinical classification, and MGFA therapy status between groups before surgery. Twenty patients were lost of follow up during the first year and were excluded. Our final group included 40 patients in each group. Three patients in TCT group (7.5%) and 6 patients in the TST group (15%) developed surgical complications. At 1 year of follow-up, 7 patients (17.5%) of the TCT group were asymptomatic in comparison with 15 patients (37.5%) of group TST, after 10 years of follow-up, 26 cases (72.9%) in group TCT were asymptomatic in comparison with 29 cases (80.5%) of group TST. Outcomes 10 years after surgery by MGFA post-intervention status showed that complete stable remission was achieved in 8 (21.6%) patients of the TCT group, and in 20 patients (55.5%) of the TST group.
Conclusions: Transcervical and transsternal thymectomy are safe and result in significant improvement of patients with Myasthenia Gravis. TST has superior results in terms of complete stable remission at 10 years.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Inclusion criteria were a clinical diagnosis of MG confirmed by biochemical or physiologic studies and a CT excluding thymoma. -
Exclusion Criteria:
Exclusion criteria were contraindications for major surgery.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Transcervical Thymectomy
50 patients were randomized to transcervical thymectomy for treatment of myasthenia gravis.
|
Transcervical Thymectomy.
All transcervical thymectomies were performed with an 8 cm transversal cervicotomy was performed approximately 2 cm above the sternal notch.
Musculocutaneous flaps were developed up to the thyroid cartilage and the suprasternal notch.
Strap muscles were split in the middle and retracted laterally.
The upper horns of the thymus were exposed and were freed up to the level of the innominate vein.
All tributary veins were suture ligated.
A sternal retractor was then placed to retract the sternum upward until the patient was nearly lifted off the table.
The rest of the Thymus was dissected, from the pericardium and the pleura.
Care was specially taken to remove as much fatty tissue adjacent to the thymus as possible preserving the phrenic nerves.
|
Experimental: TranssternalThymectomy
50 patients were randomized to transternal thymectomy for treatment of myasthenia gravis.
|
Transsternal Thymectomy.
A standard formal median sternotomy was carried out.
The sternum was retracted laterally using an automatic retractor.
All thymic tissue with the adjacent adipose tissue was removed starting with the inferior horns of the thymus.
Thymic vessels were ligated and dissection was continued until the upper horns could be separated from the thyroid.
A mediastinal tube was placed before closing the sternum and was kept in close suction for 2 to 3 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacological remission of MG.
Time Frame: 10 years
|
Remission of MG classified according to MGFA Post intervention status for postoperative remission of Myasthenia Gravis
|
10 years
|
Clinical remission of MG.
Time Frame: 10 years
|
Remission of MG classified according to MGFA Post intervention status for postoperative remission of Myasthenia Gravis
|
10 years
|
Pharmacological and clinical remission of MG.
Time Frame: 10 years
|
Remission of MG classified according to MGFA Post intervention status for postoperative remission of Myasthenia Gravis
|
10 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Immune System Diseases
- Neoplasms
- Autoimmune Diseases of the Nervous System
- Autoimmune Diseases
- Neoplasms by Site
- Neuromuscular Diseases
- Neurodegenerative Diseases
- Nervous System Neoplasms
- Paraneoplastic Syndromes, Nervous System
- Paraneoplastic Syndromes
- Neuromuscular Junction Diseases
- Myasthenia Gravis
Other Study ID Numbers
- CIBH 531 (1995)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Myasthenia Gravis, Thymectomy
-
Assiut UniversityRecruitingNervous System Diseases | Autoimmune Diseases of the Nervous System | Thymoma | Myasthenia Gravis | Neuromuscular Junction Diseases | Myasthenia Gravis, Generalized | Myasthenia Gravis Crisis | Myasthenia Gravis, Ocular | Myasthenia Gravis, Juvenile Form | Thymus Hyperplasia | Myasthenia Gravis With Exacerbation... and other conditionsEgypt
-
Shanghai Pulmonary Hospital, Shanghai, ChinaRecruitingThymoma | Myasthenia Gravis Associated With Thymoma | ThymectomyChina
-
Universiti Putra MalaysiaEnrolling by invitationExperimental MyastheniaChina
-
Universiti Putra MalaysiaCompletedExperimental MyastheniaChina
-
Alexion Pharmaceuticals, Inc.CompletedMyasthenia Gravis | Myasthenia Gravis, Generalized | Myasthenia Gravis, Juvenile FormUnited States, Japan, Netherlands
-
COUR Pharmaceutical Development Company, Inc.Not yet recruitingMyasthenia Gravis | Generalized Myasthenia | AChR Myasthenia Gravis | MuSK MGUnited States
-
Fondation Ophtalmologique Adolphe de RothschildCompleted
-
University of Missouri-ColumbiaUniversity of Kansas Medical CenterRecruitingGeneralized Myasthenia GravisUnited States
-
Fondazione Policlinico Universitario Agostino Gemelli...Recruiting
-
Alexion Pharmaceuticals, Inc.RecruitingGeneralized Myasthenia GravisChina, United States, Spain, United Kingdom, Korea, Republic of, Italy, Germany, Japan, Brazil, France, Netherlands, Taiwan, Turkey, Israel, Poland, Austria, Denmark, Portugal, Canada, Serbia, Argentina, Switzerland
Clinical Trials on Transcervical Thymectomy
-
Shanghai Pulmonary Hospital, Shanghai, ChinaRecruiting
-
University of Alabama at BirminghamCompletedCervical Ripening | Labor InductionUnited States
-
Shanghai Zhongshan HospitalShanghai Minhang Central Hospital; Xuhui Central Hospital, Shanghai; Zhongshan... and other collaboratorsCompleted
-
Charite University, Berlin, GermanyNeuroCure Clinical Research Center, Charite, Berlin; Department of Surgery,... and other collaboratorsActive, not recruitingMyasthenia GravisGermany
-
Jiang FanRecruitingThymoma | Myasthenia Gravis | Mediastinal TumorChina
-
University of Alabama at BirminghamTerminatedFetal Membranes, Premature Rupture | Labor, Induced/ISUnited States
-
National University Health System, SingaporeCompletedThymic Carcinoid | Multiple Endocrine Neoplasia Type 1 (MEN-1)Singapore
-
Chang Gung Memorial HospitalCompletedSecondary Hyperparathyroidism Due to Renal CausesTaiwan
-
Hadassah Medical OrganizationUnknown
-
Hologic, Inc.QST Consultations, Ltd.TerminatedReproductive SterilizationUnited States, Australia, Mexico