Video-assisted Thoracoscopic Thymectomy Versus Subxiphoid Procedure

November 14, 2022 updated by: The Second Hospital of Shandong University

Video-assisted Thoracoscopic Thymectomy Versus Subxiphoid Thymectomy: Short- Term and Long- Term Results

Surgerys used in thymectomy for myasthenia gravis and anterior mediastinal tumours have become much less invasive in recent years. In our study, the surgical technique which resected the thymus below the xiphoid process and the technique which was regarded as conventional video- assisted thoracoscopic surgery (VATS) thymectomy was compared.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250033
        • Recruiting
        • Yunpeng
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Thymoma with or without myasthenia gravis；
  2. Generalized myasthenia gravis not sensitive to conservative medicine treatment;
  3. Good cardiopulmonary function.

Exclusion Criteria:

  1. Cardiopulmonary function can't bear surgery;
  2. Generalized myasthenia gravis with MuSK(+).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Subxiphoid group
Subxiphoid procedure for thymectomy.
Procedure: Subxiphoid surgery procedure
Subxiphoid procedure for thymectomy
Active Comparator: VATS group
Video-assisted thoracoscopic thymectomy through chest wall.
Procedure: VATS surgery procedure
VATS procedure for thymectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale of postoperative pain
Time Frame: within 3 days
in score
within 3 days
Operation time
Time Frame: one day
in minutes
one day
The amount of blood loss
Time Frame: one day
in milliliter
one day
Duration of drainage
Time Frame: with 7 days
in days
with 7 days
Duration of hospital stay
Time Frame: with 7 days
in days
with 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete remission rates
Time Frame: 5 years
Complete remission rates after 5 year follow-up of thymectomy for myasthenia gravis
5 years
Recurrence rate
Time Frame: 5 years
Recurrence rate after 5 year follow-up of thymectomy for thymoma
5 years
Overall survival
Time Frame: within 10 years
Overall survival in rate
within 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2020

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2027

Study Registration Dates

First Submitted

January 8, 2020

First Submitted That Met QC Criteria

January 8, 2020

First Posted (Actual)

January 10, 2020

Study Record Updates

Last Update Posted (Actual)

November 16, 2022

Last Update Submitted That Met QC Criteria

November 14, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Subxiphoid ZYP1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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