Transsternal Versus Transcervical Thymectomy

NCT03825185 | Completed DMC

• 1 other identifier: CIBH 531 (1995)
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Myasthenia Gravis, Thymectomy

Outcome Measures

Primary Outcomes (3)

• Pharmacological remission of MG.

  Remission of MG classified according to MGFA Post intervention status for postoperative remission of Myasthenia Gravis

  10 years

• Clinical remission of MG.

  Remission of MG classified according to MGFA Post intervention status for postoperative remission of Myasthenia Gravis

  10 years

• Pharmacological and clinical remission of MG.

  Remission of MG classified according to MGFA Post intervention status for postoperative remission of Myasthenia Gravis

  10 years

Study Arms (2)

Transcervical Thymectomy

EXPERIMENTAL

50 patients were randomized to transcervical thymectomy for treatment of myasthenia gravis.

Procedure: Transcervical Thymectomy

TranssternalThymectomy

EXPERIMENTAL

50 patients were randomized to transternal thymectomy for treatment of myasthenia gravis.

Procedure: Transsternal Thymectomy

Interventions

Transcervical Thymectomy PROCEDURE

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.

Transcervical Thymectomy

Transsternal Thymectomy PROCEDURE

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.

TranssternalThymectomy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead

MeSH Terms

Conditions

Myasthenia Gravis

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: January 31, 2019
• Study Start: January 1, 1993
• Primary Completion: December 1, 2004
• Study Completion: December 1, 2018
• Last Updated: January 31, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share