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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
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myasthenia Gravis, Thymectomy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 23, 2019
    Last Updated
    January 30, 2019
    Sponsor
    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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    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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