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

December 10, 2014 updated by: Yongan Zhou, Tang-Du Hospital

Comparison of Safety and Efficacy Among "3-Hole" Subxiphorid Approach, Trans Sternal Approach and VATS in Surgical Treatment of Anterior Mediastinal Tumor

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 2

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 Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710038
        • Recruiting
        • Tangdu Hospital
        • Contact:
        • 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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: "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.
Procedure: "3-Hole" subxiphorid and subcostal approach
"3-Hole" subxiphorid and subcostal approach anterior mediastinum tumor resection
Other Names:
  • 3-Hole approach
Experimental: Trans sternal approach
Procedure: Trans sternal approach
Trans sternal approach anterior mediastinum tumor resection
Other Names:
  • median sternotomy
Experimental: VATS approach
Procedure: VATS approach
Video-assisted thoracoscope anterior mediastinum tumor resection
Other Names:
  • Video-assisted thoracoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of bleeding
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Measured by the difference between the wet weight and dry weight of surgical gauze
Participants will be followed for the duration of hospital stay, an expected average of 5 days
Rate of conversions to thoracotomy
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Only in "3-Hole" subxiphorid group and VATS group
Participants will be followed for the duration of hospital stay, an expected average of 5 days
Duration of operation
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Participants will be followed for the duration of hospital stay, an expected average of 5 days
Mortality rate
Time Frame: up to 10 years
Death caused by operation or complications
up to 10 years
Overall survival
Time Frame: up to 10 years
From randomization to any cause of death
up to 10 years
Quality of life
Time Frame: up to 10 years after operation
Measured by EORTC QLQ-C30 (version 3) scale
up to 10 years after operation
Number of Participants with Adverse Events
Time Frame: up to 8weekss afte operation
up to 8weekss afte operation

Collaborators and Investigators

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

Sponsor

Tang-Du Hospital

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

August 1, 2014

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

November 26, 2014

First Submitted That Met QC Criteria

December 10, 2014

First Posted (Estimate)

December 15, 2014

Study Record Updates

Last Update Posted (Estimate)

December 15, 2014

Last Update Submitted That Met QC Criteria

December 10, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TangduH717544

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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