The Curative Effect of Extended Thymectomy Performed Through Subxiphoid-right VATS Approach With Elevation of Sternum

A Prospective Multicenter Comparative Study of the Curative Effect of Extended Thymectomy Performed Through the Subxiphoid VATS Approach With Double Elevation of the Sternum Versus Intercostal VATS Approach

Extended thymectomy is the main treatment for thymoma and other anterior mediastinal diseases. Video-assisted thoracic surgery(VATS) plays an important role in the surgery of extended thymectomy. Now, VATS thymectomy through intercostal approach has been the commonly used minimally invasive surgical procedure for thymus surgery and is applied worldwide. But the intercostal approach may cause residue of thymus tissue and chronic pain. In 2013, doctor Marcin Zielin´ski form Poland reported a new technique of minimally invasive extended thymectomy performed through the VATS approach with double elevation of the sternum. And their early results proved this technique is probably the least invasive and the most complete technique of VATS thymectomy with excellent cosmetic results. Until now, doctor Jiang Fan form Shanghai Pulmonary Hospital has performed 50 cases extended thymectomy through the subxiphoid approach with double elevation of the sternum by VATS. This study is designed to compare the curative effect between this new method and traditional intercostal VATS.

Study Overview

• Status: Recruiting
• Conditions: Thymoma; Myasthenia Gravis; Mediastinal Tumor
• Intervention / Treatment: Procedure: Subxiphoid approach extended thymectomy by VATS; Procedure: Intercostal approach extended thymectomy by VATS

Detailed Description

This study is a prospective multicentre cohort study.The main study content is comparative study of the curative effect of extended thymectomy performed through the subxiphoid-right video-thoracoscopic approach with double elevation of the sternum versus intercostal video-thoracoscopic approach, divided into subxiphoid and intercostal groups. Communicating with the surgeon and patients who meet the inclusion criteria, decide whether to enter the subxiphoid or intercostal group. Subxiphoid group with subxiphoid-right video-thoracoscopic approach under double elevation of the sternum in extended thymectomy , intercostal group with traditional intercostal video-assisted thoracoscopic surgery in extended thymectomy. By collecting personal information of two groups of patients and the corresponding observation indicators to analyze whether the subxiphoid-right VATS approach with double elevation of the sternum is the least invasive and the most complete technique of VATS thymectomy.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiang Fan, MD，PhD; Phone Number: +86 13764271861; Email: drjiangfan@yahoo.com
• Study Contact Backup: Name: Nan Song, MD; Phone Number: +86 18016224489; Email: lnsongnan@163.com

Study Locations

• China
  • Hainan
    • Haikou, Hainan, China, 570100
      • Recruiting
      • The Second Affiliated Hospital of Hainan Medical University
      • Contact: Biao Li, MD; Email: libiao70@163.com
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Recruiting
      • Shanghai Pulmonary Hospital
      • Contact: Jiang Fan, MD; Phone Number: +86 13764271861; Email: drjiangfan@yahoo.com
      • Principal Investigator: Jiang Fan, MD
      • Principal Investigator: Nan Song, MD
      • Principal Investigator: Wenxin He, MD
      • Principal Investigator: Liang Duan, MD
      • Principal Investigator: Tao Ge, MD
  • Shanxi
    • Taiyuan, Shanxi, China, 030000
      • Recruiting
      • Shanxi Provincial Cancer Hospital
      • Contact: Rongsheng Zhang, MD; Email: 17736924293@qq.com
  • Zhejiang
    • Shaoxing, Zhejiang, China, 312000
      • Recruiting
      • Shaoxing Center Hospital
      • Contact: Xiaobing Li, MD; Email: 2487400565@qq.com
    • Taizhou, Zhejiang, China, 318000
      • Recruiting
      • Taizhou Center Hospital (Taizhou Unoversity Hospital)
      • Contact: Xuelin Zhang, MD; Email: zxlmeet@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. MG with thymic hyperplasia, thymoma or other anterior mediastinum disease
2. Masaoka stagingⅠ-Ⅱ
3. Patients with normal cardio-pulmonary function before operation, BMI<30

Exclusion Criteria:

1. Unable to tolerate surgery
2. Masaoka staging Ⅲ-Ⅳ
3. Patients who have undergone previous surgery or radiotherapy
4. Myasthenia crisis
5. Chronic pain or using opioid analgesics before surgery
6. Preoperative mental disorders such as excessive anxiety
7. Patients who underwent previous mediastinal surgery or cardiac surgery
8. Patients with thoracic deformity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subxiphoid approach; The patients in subxiphoid group will get subxiphoid approach extended thymectomy by VATS. Whole dissection was performed through a 4 to 7cm transverse subxiphoid incision, and a single 5-mm port was inserted into the right chest cavity for the video thoracoscope and subsequently for the chest tube. The sternum was elevated with two hooks connected to the sternal frame. The lower hook was inserted through the subxiphoid incision, and the superior hook was inserted percutaneously after the mediastinal tissue including the major mediastinal vessels was dissected from the inner surface of the sternum. The thymus and fatty tissue of the anterior mediastinum and the aorta-pulmonary window was completely removed.	Procedure: Subxiphoid approach extended thymectomy by VATS; Extended thymectomy performed through the subxiphoid-right VATS approach with double elevation of the sternum
Experimental: Intercostal approach; The patients in intercostal group will get intercostal approach extended thymectomy by VATS.	Procedure: Intercostal approach extended thymectomy by VATS; Extended thymectomy performed through the traditional intercostal VATS approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resection rate of thymus tissue	The thymus tissue resection rate was calculated by comparing the preoperative and postoperative CT images.	1 month
Acute Pain Score	Visual analogue score (VAS-score) is to asses the development of acute pain after surgery. 11 point numeric rating scale of 0 represented "no pain"and a score of 10 represented "worst pain " in patients 24 hours after operation.	24 hours
Life Quality of Patients	The EuroQol 5 Dimensions (EQ-5D) is used. EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. EQ-5D includes self-reported quality of life, where 0 is the worst and 100 is the best imaginable health state.	6 months
Myasthenia Gravis remission rate	The Quantitative Myasthenia Gravis scale (QMG) is used. It includes 13 items, such as eyelid ptosis, diplopia, eyelid closure, speech, swallowing, vital capacity, lift, grip and lower extremity elevation. QMG can evaluate myasthenia, and total score of the scale is from 0 (no myasthenia) to 39 (the most severe myasthenia). If the difference between the two assessment scores is greater than 3.5, it is considered that the symptoms of myasthenia gravis relieved.	1 year
Disease-free survival	From grouping to the recurrence of disease or the time of death due to disease progression.	Up to 5 years
Recurrence rate	The rate of patients recurrence after surgery	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality rate	Death caused by operation or complications	Up to 5 years
Overall survival	From grouping to any cause of death	Up to 5 years
Operation time	Time of the surgical operation	1 week
Length of stay	The time of the patients in hospital	1 month
Complication rate	The incidence rate of postoperative complications in the two groups	1 month
Chronic Pain Score	Visual analogue score (VAS-score) is to asses the development of chronic pain after surgery. 11 point numeric rating scale of 0 represented "no pain"and a score of 10 represented "worst pain " in patients 6 months after operation.	6 months

Collaborators and Investigators

• Sponsor: Jiang Fan

Publications and helpful links

General Publications

• Zielinski M, Czajkowski W, Gwozdz P, Nabialek T, Szlubowski A, Pankowski J. Resection of thymomas with use of the new minimally-invasive technique of extended thymectomy performed through the subxiphoid-right video-thoracoscopic approach with double elevation of the sternum. Eur J Cardiothorac Surg. 2013 Aug;44(2):e113-9; discussion e119. doi: 10.1093/ejcts/ezt224. Epub 2013 Jun 12.
• Zielinski M, Hauer L, Hauer J, Pankowski J, Nabialek T, Szlubowski A. Comparison of complete remission rates after 5 year follow-up of three different techniques of thymectomy for myasthenia gravis. Eur J Cardiothorac Surg. 2010 May;37(5):1137-43. doi: 10.1016/j.ejcts.2009.11.029. Epub 2010 Feb 8.
• Friedant AJ, Handorf EA, Su S, Scott WJ. Minimally Invasive versus Open Thymectomy for Thymic Malignancies: Systematic Review and Meta-Analysis. J Thorac Oncol. 2016 Jan;11(1):30-8. doi: 10.1016/j.jtho.2015.08.004.
• Takeo S, Sakada T, Yano T. Video-assisted extended thymectomy in patients with thymoma by lifting the sternum. Ann Thorac Surg. 2001 May;71(5):1721-3. doi: 10.1016/s0003-4975(00)02697-7.
• Hess NR, Sarkaria IS, Pennathur A, Levy RM, Christie NA, Luketich JD. Minimally invasive versus open thymectomy: a systematic review of surgical techniques, patient demographics, and perioperative outcomes. Ann Cardiothorac Surg. 2016 Jan;5(1):1-9. doi: 10.3978/j.issn.2225-319X.2016.01.01.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: July 7, 2018
• First Submitted That Met QC Criteria: July 29, 2018
• First Posted (Actual): August 3, 2018

Study Record Updates

• Last Update Posted (Actual): May 7, 2021
• Last Update Submitted That Met QC Criteria: May 6, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Myasthenia Gravis; VATS; thymoma; thymectomy; subxiphoid; elevation of the sternum; curative effect
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphatic Diseases; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Neoplasms by Site; Thoracic Neoplasms; Neuromuscular Diseases; Neurodegenerative Diseases; Nervous System Neoplasms; Neoplasms, Complex and Mixed; Paraneoplastic Syndromes, Nervous System; Paraneoplastic Syndromes; Neuromuscular Junction Diseases; Mediastinal Diseases; Thoracic Diseases; Thymoma; Thymus Neoplasms; Myasthenia Gravis; Mediastinal Neoplasms
• Other Study ID Numbers: K18-137

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No