Transsternal Versus Transcervical Thymectomy
Primary Purpose
Myasthenia Gravis, Thymectomy
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transcervical Thymectomy
Transsternal Thymectomy
Sponsored by
About this trial
This is an interventional treatment trial for Myasthenia Gravis, Thymectomy
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Transcervical Thymectomy
TranssternalThymectomy
Arm Description
50 patients were randomized to transcervical thymectomy for treatment of myasthenia gravis.
50 patients were randomized to transternal thymectomy for treatment of myasthenia gravis.
Outcomes
Primary Outcome Measures
Pharmacological remission of MG.
Remission of MG classified according to MGFA Post intervention status for postoperative remission of Myasthenia Gravis
Clinical remission of MG.
Remission of MG classified according to MGFA Post intervention status for postoperative remission of Myasthenia Gravis
Pharmacological and clinical remission of MG.
Remission of MG classified according to MGFA Post intervention status for postoperative remission of Myasthenia Gravis
Secondary Outcome Measures
Full Information
NCT ID
NCT03825185
First Posted
January 23, 2019
Last Updated
January 30, 2019
Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
1. Study Identification
Unique Protocol Identification Number
NCT03825185
Brief Title
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
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 1993 (Actual)
Primary Completion Date
December 1, 2004 (Actual)
Study Completion Date
December 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myasthenia Gravis, Thymectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transcervical Thymectomy
Arm Type
Experimental
Arm Description
50 patients were randomized to transcervical thymectomy for treatment of myasthenia gravis.
Arm Title
TranssternalThymectomy
Arm Type
Experimental
Arm Description
50 patients were randomized to transternal thymectomy for treatment of myasthenia gravis.
Intervention Type
Procedure
Intervention Name(s)
Transcervical Thymectomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Transsternal Thymectomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pharmacological remission of MG.
Description
Remission of MG classified according to MGFA Post intervention status for postoperative remission of Myasthenia Gravis
Time Frame
10 years
Title
Clinical remission of MG.
Description
Remission of MG classified according to MGFA Post intervention status for postoperative remission of Myasthenia Gravis
Time Frame
10 years
Title
Pharmacological and clinical remission of MG.
Description
Remission of MG classified according to MGFA Post intervention status for postoperative remission of Myasthenia Gravis
Time Frame
10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Plan to Share IPD
No
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Transsternal Versus Transcervical Thymectomy
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