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

Sponsor

Jiang Fan (Other)

Overall Status

Recruiting

CT.gov ID

NCT03613272

Collaborator

(none)

200

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Thymoma Myasthenia Gravis Mediastinal Tumor	Procedure: Subxiphoid approach extended thymectomy by VATS Procedure: Intercostal approach extended thymectomy by VATS	N/A

Detailed Description

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jul 1, 2018

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Resection rate of thymus tissue [1 month]
The thymus tissue resection rate was calculated by comparing the preoperative and postoperative CT images.
Acute Pain Score [24 hours]
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 [6 months]
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 [1 year]
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 [Up to 5 years]
From grouping to the recurrence of disease or the time of death due to disease progression.
Recurrence rate [Up to 5 years]
The rate of patients recurrence after surgery

Secondary Outcome Measures

Mortality rate [Up to 5 years]
Death caused by operation or complications
Overall survival [Up to 5 years]
From grouping to any cause of death
Operation time [1 week]
Time of the surgical operation
Length of stay [1 month]
The time of the patients in hospital
Complication rate [1 month]
The incidence rate of postoperative complications in the two groups
Chronic Pain Score [6 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Second Affiliated Hospital of Hainan Medical University	Haikou	Hainan	China	570100
2	Shanghai Pulmonary Hospital	Shanghai	Shanghai	China	200433
3	Shanxi Provincial Cancer Hospital	Taiyuan	Shanxi	China	030000
4	Shaoxing Center Hospital	Shaoxing	Zhejiang	China	312000
5	Taizhou Center Hospital (Taizhou Unoversity Hospital)	Taizhou	Zhejiang	China	318000