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

Primary Purpose

Thymoma, Myasthenia Gravis, Mediastinal Tumor

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Subxiphoid approach extended thymectomy by VATS
Intercostal approach extended thymectomy by VATS
Sponsored by
Jiang Fan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thymoma focused on measuring thymoma, thymectomy, Myasthenia Gravis, VATS, subxiphoid, elevation of the sternum, curative effect

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Second Affiliated Hospital of Hainan Medical UniversityRecruiting
  • Shanghai Pulmonary HospitalRecruiting
  • Shanxi Provincial Cancer HospitalRecruiting
  • Shaoxing Center HospitalRecruiting
  • Taizhou Center Hospital (Taizhou Unoversity Hospital)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Subxiphoid approach

Intercostal approach

Arm Description

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.

The patients in intercostal group will get intercostal approach extended thymectomy by VATS.

Outcomes

Primary Outcome Measures

Resection rate of thymus tissue
The thymus tissue resection rate was calculated by comparing the preoperative and postoperative CT images.
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.
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.
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.
Disease-free survival
From grouping to the recurrence of disease or the time of death due to disease progression.
Recurrence rate
The rate of patients recurrence after surgery

Secondary Outcome Measures

Mortality rate
Death caused by operation or complications
Overall survival
From grouping to any cause of death
Operation time
Time of the surgical operation
Length of stay
The time of the patients in hospital
Complication rate
The incidence rate of postoperative complications in the two groups
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.

Full Information

First Posted
July 7, 2018
Last Updated
May 6, 2021
Sponsor
Jiang Fan
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1. Study Identification

Unique Protocol Identification Number
NCT03613272
Brief Title
The Curative Effect of Extended Thymectomy Performed Through Subxiphoid-right VATS Approach With Elevation of Sternum
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jiang Fan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thymoma, Myasthenia Gravis, Mediastinal Tumor
Keywords
thymoma, thymectomy, Myasthenia Gravis, VATS, subxiphoid, elevation of the sternum, curative effect

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model 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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Subxiphoid approach
Arm Type
Experimental
Arm Description
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.
Arm Title
Intercostal approach
Arm Type
Experimental
Arm Description
The patients in intercostal group will get intercostal approach extended thymectomy by VATS.
Intervention Type
Procedure
Intervention Name(s)
Subxiphoid approach extended thymectomy by VATS
Intervention Description
Extended thymectomy performed through the subxiphoid-right VATS approach with double elevation of the sternum
Intervention Type
Procedure
Intervention Name(s)
Intercostal approach extended thymectomy by VATS
Intervention Description
Extended thymectomy performed through the traditional intercostal VATS approach
Primary Outcome Measure Information:
Title
Resection rate of thymus tissue
Description
The thymus tissue resection rate was calculated by comparing the preoperative and postoperative CT images.
Time Frame
1 month
Title
Acute Pain Score
Description
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.
Time Frame
24 hours
Title
Life Quality of Patients
Description
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.
Time Frame
6 months
Title
Myasthenia Gravis remission rate
Description
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.
Time Frame
1 year
Title
Disease-free survival
Description
From grouping to the recurrence of disease or the time of death due to disease progression.
Time Frame
Up to 5 years
Title
Recurrence rate
Description
The rate of patients recurrence after surgery
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Mortality rate
Description
Death caused by operation or complications
Time Frame
Up to 5 years
Title
Overall survival
Description
From grouping to any cause of death
Time Frame
Up to 5 years
Title
Operation time
Description
Time of the surgical operation
Time Frame
1 week
Title
Length of stay
Description
The time of the patients in hospital
Time Frame
1 month
Title
Complication rate
Description
The incidence rate of postoperative complications in the two groups
Time Frame
1 month
Title
Chronic Pain Score
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: MG with thymic hyperplasia, thymoma or other anterior mediastinum disease Masaoka stagingⅠ-Ⅱ Patients with normal cardio-pulmonary function before operation, BMI<30 Exclusion Criteria: Unable to tolerate surgery Masaoka staging Ⅲ-Ⅳ Patients who have undergone previous surgery or radiotherapy Myasthenia crisis Chronic pain or using opioid analgesics before surgery Preoperative mental disorders such as excessive anxiety Patients who underwent previous mediastinal surgery or cardiac surgery Patients with thoracic deformity
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiang Fan, MD,PhD
Phone
+86 13764271861
Email
drjiangfan@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nan Song, MD
Phone
+86 18016224489
Email
lnsongnan@163.com
Facility Information:
Facility Name
The Second Affiliated Hospital of Hainan Medical University
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570100
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Biao Li, MD
Email
libiao70@163.com
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiang Fan, MD
Phone
+86 13764271861
Email
drjiangfan@yahoo.com
First Name & Middle Initial & Last Name & Degree
Jiang Fan, MD
First Name & Middle Initial & Last Name & Degree
Nan Song, MD
First Name & Middle Initial & Last Name & Degree
Wenxin He, MD
First Name & Middle Initial & Last Name & Degree
Liang Duan, MD
First Name & Middle Initial & Last Name & Degree
Tao Ge, MD
First Name & Middle Initial & Last Name & Degree
Hao Li, MD
Facility Name
Shanxi Provincial Cancer Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rongsheng Zhang, MD
Email
17736924293@qq.com
Facility Name
Shaoxing Center Hospital
City
Shaoxing
State/Province
Zhejiang
ZIP/Postal Code
312000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaobing Li, MD
Email
2487400565@qq.com
Facility Name
Taizhou Center Hospital (Taizhou Unoversity Hospital)
City
Taizhou
State/Province
Zhejiang
ZIP/Postal Code
318000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuelin Zhang, MD
Email
zxlmeet@126.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23761413
Citation
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.
Results Reference
result
PubMed Identifier
20117014
Citation
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.
Results Reference
result
PubMed Identifier
26762737
Citation
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.
Results Reference
result
PubMed Identifier
11383846
Citation
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.
Results Reference
result
PubMed Identifier
26904425
Citation
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.
Results Reference
result

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

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