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

NCT02317224 | Unknown Phase 2 DMC

• 1 other identifier: TangduH717544
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Thymectomy; Myasthenia Gravis

Keywords

3-Hole approach; extended thymectomy; myasthenia gravis; safety; effectiveness

Outcome Measures

Primary Outcomes (7)

• Amount of bleeding

  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

  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

  Participants will be followed for the duration of hospital stay, an expected average of 5 days

• Mortality rate

  Death caused by operation or complications

  up to 10 years

• Overall survival

  From randomization to any cause of death

  up to 10 years

• Quality of life

  Measured by EORTC QLQ-C30 (version 3) scale

  up to 10 years after operation

• Number of Participants with Adverse Events

  up to 8weekss afte operation

Study Arms (3)

"3-Hole" subxiphorid and subcostal approach

EXPERIMENTAL

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

Trans sternal approach

EXPERIMENTAL

Procedure: Trans sternal approach

VATS approach

EXPERIMENTAL

Procedure: VATS approach

Interventions

"3-Hole" subxiphorid and subcostal approach PROCEDURE

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

Also known as: 3-Hole approach

"3-Hole" subxiphorid and subcostal approach

Trans sternal approach PROCEDURE

Trans sternal approach anterior mediastinum tumor resection

Also known as: median sternotomy

Trans sternal approach

VATS approach PROCEDURE

Video-assisted thoracoscope anterior mediastinum tumor resection

Also known as: Video-assisted thoracoscope

VATS approach

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

Tangdu hospital

Xi'an, Shaanxi, 710038, China

RECRUITING

MeSH Terms

Conditions

Myasthenia Gravis

Interventions

Sternotomy

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thoracic Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Yong-an Zhou, MD

CONTACT

+86 029 84717544; zhou.yongan@163.com

Qiang Lu, MD

CONTACT

+86 029 84717548; luqianglu@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 26, 2014
• First Posted: December 15, 2014
• Study Start: August 1, 2014
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 15, 2014

Record last verified: 2014-12

Locations

CN (1)