Clinical trial NCT03825185: Transsternal Versus Transcervical Thymectomy
Official title: Transsternal Versus Transcervical Thymectomy for the Management of Myasthenia Gravis: A Randomized Controlled Trial With a Mean Follow-up of 10 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myasthenia Gravis, Thymectomy
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 100 patients with diagnosis of MG referred to our center for surgical treatment between 1993 and 2003 were invited to participate in the study. Software (Power and Precision, Biostat, NJ) was used for sample size calculation. Software (G\* Power 3.1) was used for sample size calculation. Sample size was calculated based on a 4.0% difference in the remission rate between TC (40%) and TS (44%). The calculated sample size was 26 patients in each group. Considering a 10 to 20% loss of follow up in the long term, a total of 50 patients per group were included.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pharmacological remission of MG.
timeFrame: 10 years
measure: Clinical remission of MG.
timeFrame: 10 years
measure: Pharmacological and clinical remission of MG.
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
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