ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 14 of 19 for:    Recruiting, Not yet recruiting, Available Studies | "Myasthenia Gravis"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02317224
Recruitment Status : Recruiting
First Posted : December 15, 2014
Last Update Posted : December 15, 2014
Sponsor:
Information provided by (Responsible Party):
Yongan Zhou, Tang-Du Hospital

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.

Condition or disease Intervention/treatment Phase
Thymectomy Myasthenia Gravis Procedure: "3-Hole" subxiphorid and subcostal approach Procedure: Trans sternal approach Procedure: VATS approach Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2014
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


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 Name: 3-Hole approach

Experimental: Trans sternal approach Procedure: Trans sternal approach
Trans sternal approach anterior mediastinum tumor resection
Other Name: median sternotomy

Experimental: VATS approach Procedure: VATS approach
Video-assisted thoracoscope anterior mediastinum tumor resection
Other Name: Video-assisted thoracoscope




Primary Outcome Measures :
  1. 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

  2. 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

  3. Duration of operation [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days ]
  4. Mortality rate [ Time Frame: up to 10 years ]
    Death caused by operation or complications

  5. Overall survival [ Time Frame: up to 10 years ]
    From randomization to any cause of death

  6. Quality of life [ Time Frame: up to 10 years after operation ]
    Measured by EORTC QLQ-C30 (version 3) scale

  7. Number of Participants with Adverse Events [ Time Frame: up to 8weekss afte operation ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02317224


Contacts
Contact: Yong-an Zhou, MD +86 029 84717544 zhou.yongan@163.com
Contact: Qiang Lu, MD +86 029 84717548 luqianglu@126.com

Locations
China, Shaanxi
Tangdu hospital Recruiting
Xi'an, Shaanxi, China, 710038
Contact: Yongan Zhou, MD    +86 029 84717544    zhou.yongan@163.com   
Contact: Qiang Lu, MD    +86 029 84717548    luqianglu@126.com   
Sponsors and Collaborators
Tang-Du Hospital

Responsible Party: Yongan Zhou, Associate Professor, Tang-Du Hospital
ClinicalTrials.gov Identifier: NCT02317224     History of Changes
Other Study ID Numbers: TangduH717544
First Posted: December 15, 2014    Key Record Dates
Last Update Posted: December 15, 2014
Last Verified: December 2014

Keywords provided by Yongan Zhou, Tang-Du Hospital:
3-Hole approach
extended thymectomy
myasthenia gravis
safety
effectiveness

Additional relevant MeSH terms:
Myasthenia Gravis
Mediastinal Neoplasms
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Mediastinal Diseases
Thoracic Diseases
Respiratory Tract Diseases