Video-assisted Thoracoscopic Thymectomy Versus Subxiphoid Procedure

NCT ID: NCT04223466

Last Updated: 2022-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-07

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Thymectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Subxiphoid group

Subxiphoid procedure for thymectomy.

Group Type EXPERIMENTAL

Subxiphoid surgery procedure

Intervention Type PROCEDURE

Subxiphoid procedure for thymectomy

VATS group

Video-assisted thoracoscopic thymectomy through chest wall.

Group Type ACTIVE_COMPARATOR

VATS surgery procedure

Intervention Type PROCEDURE

VATS procedure for thymectomy

Interventions

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Subxiphoid surgery procedure

Subxiphoid procedure for thymectomy

Intervention Type PROCEDURE

VATS surgery procedure

VATS procedure for thymectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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(+).
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Second Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Yunpeng

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yunpeng Zhao

Role: CONTACT

+8618766188692

Facility Contacts

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Yunpeng

Role: primary

+8618766188692

Other Identifiers

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Subxiphoid ZYP1

Identifier Type: -

Identifier Source: org_study_id

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