Back to resultsThe Safety and Efficacy of "3-Hole" Subxiphorid Approach in the Treatment of Anterior Mediastinal Tumor (3-Hole)
Primary Purpose
Thymectomy, Myasthenia Gravis
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
"3-Hole" subxiphorid and subcostal approach
Trans sternal approach
VATS approach
Sponsored by
About this trial
This is an interventional treatment trial for Thymectomy focused on measuring 3-Hole approach, extended thymectomy, myasthenia gravis, safety, effectiveness
Eligibility Criteria
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
Sites / Locations
- Tangdu hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
"3-Hole" subxiphorid and subcostal approach
Trans sternal approach
VATS approach
Arm Description
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.
Outcomes
Primary Outcome Measures
Amount of bleeding
Measured by the difference between the wet weight and dry weight of surgical gauze
Rate of conversions to thoracotomy
Only in "3-Hole" subxiphorid group and VATS group
Duration of operation
Mortality rate
Death caused by operation or complications
Overall survival
From randomization to any cause of death
Quality of life
Measured by EORTC QLQ-C30 (version 3) scale
Number of Participants with Adverse Events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02317224
Brief Title
The Safety and Efficacy of "3-Hole" Subxiphorid Approach in the Treatment of Anterior Mediastinal Tumor
Acronym
3-Hole
Official Title
Comparison of Safety and Efficacy Among "3-Hole" Subxiphorid Approach, Trans Sternal Approach and VATS in Surgical Treatment of Anterior Mediastinal Tumor
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Recruiting
Study Start Date
August 2014 (undefined)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tang-Du Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thymectomy, Myasthenia Gravis
Keywords
3-Hole approach, extended thymectomy, myasthenia gravis, safety, effectiveness
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
"3-Hole" subxiphorid and subcostal approach
Arm Type
Experimental
Arm Description
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.
Arm Title
Trans sternal approach
Arm Type
Experimental
Arm Title
VATS approach
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
"3-Hole" subxiphorid and subcostal approach
Other Intervention Name(s)
3-Hole approach
Intervention Description
"3-Hole" subxiphorid and subcostal approach anterior mediastinum tumor resection
Intervention Type
Procedure
Intervention Name(s)
Trans sternal approach
Other Intervention Name(s)
median sternotomy
Intervention Description
Trans sternal approach anterior mediastinum tumor resection
Intervention Type
Procedure
Intervention Name(s)
VATS approach
Other Intervention Name(s)
Video-assisted thoracoscope
Intervention Description
Video-assisted thoracoscope anterior mediastinum tumor resection
Primary Outcome Measure Information:
Title
Amount of bleeding
Description
Measured by the difference between the wet weight and dry weight of surgical gauze
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 5 days
Title
Rate of conversions to thoracotomy
Description
Only in "3-Hole" subxiphorid group and VATS group
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 5 days
Title
Duration of operation
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 5 days
Title
Mortality rate
Description
Death caused by operation or complications
Time Frame
up to 10 years
Title
Overall survival
Description
From randomization to any cause of death
Time Frame
up to 10 years
Title
Quality of life
Description
Measured by EORTC QLQ-C30 (version 3) scale
Time Frame
up to 10 years after operation
Title
Number of Participants with Adverse Events
Time Frame
up to 8weekss afte operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong-an Zhou, MD
Phone
+86 029 84717544
Email
zhou.yongan@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qiang Lu, MD
Phone
+86 029 84717548
Email
luqianglu@126.com
Facility Information:
Facility Name
Tangdu hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongan Zhou, MD
Phone
+86 029 84717544
Email
zhou.yongan@163.com
First Name & Middle Initial & Last Name & Degree
Qiang Lu, MD
Phone
+86 029 84717548
Email
luqianglu@126.com
12. IPD Sharing Statement
Learn more about this trial
The Safety and Efficacy of "3-Hole" Subxiphorid Approach in the Treatment of Anterior Mediastinal Tumor
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