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

NCT ID: NCT03613272

Last Updated: 2021-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2023-12-01

Brief Summary

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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

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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.

Conditions

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Thymoma Myasthenia Gravis Mediastinal Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Subxiphoid approach extended thymectomy by VATS

Intervention Type PROCEDURE

Extended thymectomy performed through the subxiphoid-right VATS approach with double elevation of the sternum

Intercostal approach

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

Group Type EXPERIMENTAL

Intercostal approach extended thymectomy by VATS

Intervention Type PROCEDURE

Extended thymectomy performed through the traditional intercostal VATS approach

Interventions

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Subxiphoid approach extended thymectomy by VATS

Extended thymectomy performed through the subxiphoid-right VATS approach with double elevation of the sternum

Intervention Type PROCEDURE

Intercostal approach extended thymectomy by VATS

Extended thymectomy performed through the traditional intercostal VATS approach

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiang Fan

OTHER

Sponsor Role lead

Responsible Party

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Jiang Fan

Chief physician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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The Second Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China

Site Status RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, China

Site Status RECRUITING

Shaoxing Center Hospital

Shaoxing, Zhejiang, China

Site Status RECRUITING

Taizhou Center Hospital (Taizhou Unoversity Hospital)

Taizhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jiang Fan, MD,PhD

Role: CONTACT

+86 13764271861

Nan Song, MD

Role: CONTACT

+86 18016224489

Facility Contacts

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Biao Li, MD

Role: primary

Jiang Fan, MD

Role: primary

+86 13764271861

Rongsheng Zhang, MD

Role: primary

Xiaobing Li, MD

Role: primary

Xuelin Zhang, MD

Role: primary

References

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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.

Reference Type RESULT
PMID: 23761413 (View on PubMed)

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.

Reference Type RESULT
PMID: 20117014 (View on PubMed)

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.

Reference Type RESULT
PMID: 26762737 (View on PubMed)

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.

Reference Type RESULT
PMID: 11383846 (View on PubMed)

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.

Reference Type RESULT
PMID: 26904425 (View on PubMed)

Other Identifiers

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K18-137

Identifier Type: -

Identifier Source: org_study_id

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