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The Safety and Efficacy of "3-Hole" Subxiphorid Approach in the Treatment of Anterior Mediastinal Tumor

NCT ID: NCT02317224

Last Updated: 2014-12-15

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2024-12-31

Brief Summary

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Surgery plays an important role in the treatment of anterior mediastinum disease. The major surgical approaches include: cervical approach, mid-sternal approach, cervical combined mid-sternal approach and video-assisted thoracoscopic approach. The cervical approach is rarely adopted because of its restricted visual field. The cervical combined mid-sternal approach have a broader field of vision, given this advantage, the surgeon can remove the thymus and its surrounding fat tissue more thoroughly. But the trauma of this approach is much larger, and the postoperative complication is also a serious problem. The video-assisted thoracoscope is often adopted by left or right approach, this minimally invasive procedure can not remove anterior mediastinum fat thoroughly. In clinical practice, the investigators designed a new method named "3-Hole" subxiphoid approach. This study is designed to compare the safety and validity between this new method and others.

Detailed Description

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Conditions

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Thymectomy Myasthenia Gravis

Keywords

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3-Hole approach extended thymectomy myasthenia gravis safety effectiveness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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"3-Hole" subxiphorid and subcostal approach

The patient were in the supine position with legs apart at about 45°, made a 2.0 cm incision below xiphoid process as the observation hole. Then made two 0.5cm operation holes along bilateral rib arch at midclavicular line, two trocars were inserted into the two holes under the guidance of B-ultrasound.After that, carbon dioxide was pumped into the anterior mediastinum, the pressure was maintained at 8 mmH2O, ultrasound scalpel and a grasping forceps were inserted through the operating ports respectively. Retrosternal space including bilateral lower poles of thymus, internal mammary arteries and phrenic nerves were exposed by both blunt and sharp dissection. Then ultrasound scalpel were used to separate the thymus and its surrounding fat tissue, cut off thymic veins by ultrasound scalpel.For patients with myasthenia gravis, bilateral mediastinal pleurae and the affected adipose tissues had been thoroughly removed.

Group Type EXPERIMENTAL

"3-Hole" subxiphorid and subcostal approach

Intervention Type PROCEDURE

"3-Hole" subxiphorid and subcostal approach anterior mediastinum tumor resection

Trans sternal approach

Group Type EXPERIMENTAL

Trans sternal approach

Intervention Type PROCEDURE

Trans sternal approach anterior mediastinum tumor resection

VATS approach

Group Type EXPERIMENTAL

VATS approach

Intervention Type PROCEDURE

Video-assisted thoracoscope anterior mediastinum tumor resection

Interventions

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"3-Hole" subxiphorid and subcostal approach

"3-Hole" subxiphorid and subcostal approach anterior mediastinum tumor resection

Intervention Type PROCEDURE

Trans sternal approach

Trans sternal approach anterior mediastinum tumor resection

Intervention Type PROCEDURE

VATS approach

Video-assisted thoracoscope anterior mediastinum tumor resection

Intervention Type PROCEDURE

Other Intervention Names

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3-Hole approach median sternotomy Video-assisted thoracoscope

Eligibility Criteria

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Inclusion Criteria

* MG with thymic hyperplasia, thymoma or other anterior mediastinum disease
* Masaoka stagingⅠ-Ⅱ
* Thymoma without MG
* Mass diameter \<10cm
* Inform Consent Form is signed

Exclusion Criteria

* Unable to tolerate surgery
* myasthenic crisis
* Masaoka staging Ⅲ-Ⅳ
* Patients who have undergone previous surgery or radiotherapy
* pregnancy , breastfeeding or younger than 18 years old
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tang-Du Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yongan Zhou

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tangdu hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yong-an Zhou, MD

Role: CONTACT

Phone: +86 029 84717544

Email: [email protected]

Qiang Lu, MD

Role: CONTACT

Phone: +86 029 84717548

Email: [email protected]

Facility Contacts

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Yongan Zhou, MD

Role: primary

Qiang Lu, MD

Role: backup

Other Identifiers

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TangduH717544

Identifier Type: -

Identifier Source: org_study_id