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

NCT03613272 | Unknown

• 1 other identifier: K18-137
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 5

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.

Conditions

Thymoma; Myasthenia Gravis; Mediastinal Tumor

Keywords

thymoma; thymectomy; Myasthenia Gravis; VATS; subxiphoid; elevation of the sternum; curative effect

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• Mortality rate

  Up to 5 years

• Overall survival

  Up to 5 years

• Operation time

  1 week

• Length of stay

  1 month

• Complication rate

  1 month

Study Arms (2)

Subxiphoid approach

EXPERIMENTAL

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

Intercostal approach

EXPERIMENTAL

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

Procedure: Intercostal approach extended thymectomy by VATS

Interventions

Subxiphoid approach extended thymectomy by VATS PROCEDURE

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

Subxiphoid approach

Intercostal approach extended thymectomy by VATS PROCEDURE

Extended thymectomy performed through the traditional intercostal VATS approach

Intercostal approach

Eligibility Criteria

• Age: 20 Years - 70 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
• Patients with normal cardio-pulmonary function before operation, BMI\<30

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiang Fan: lead

Study Sites (5)

The Second Affiliated Hospital of Hainan Medical University

Haikou, Hainan, 570100, China

RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, 030000, China

RECRUITING

Shaoxing Center Hospital

Shaoxing, Zhejiang, 312000, China

RECRUITING

Taizhou Center Hospital (Taizhou Unoversity Hospital)

Taizhou, Zhejiang, 318000, China

RECRUITING

Related Publications (5)

• 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.

  PMID: 23761413 RESULT

• 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.

  PMID: 20117014 RESULT

• 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.

  PMID: 26762737 RESULT

• 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.

  PMID: 11383846 RESULT

• 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.

  PMID: 26904425 RESULT

MeSH Terms

Conditions

Thymoma; Myasthenia Gravis; Mediastinal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Thymus Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lymphatic Diseases; Hemic and Lymphatic Diseases; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Mediastinal Diseases; Thoracic Diseases; Respiratory Tract Diseases

Central Study Contacts

Jiang Fan, MD，PhD

CONTACT

+86 13764271861; drjiangfan@yahoo.com

Nan Song, MD

CONTACT

+86 18016224489; lnsongnan@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician

Model Details: 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.

Study Record Dates

• First Submitted: July 7, 2018
• First Posted: August 3, 2018
• Study Start: July 1, 2018
• Primary Completion: July 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 7, 2021

Record last verified: 2021-05

Locations

CN (5)