Video-assisted Thoracoscopic Thymectomy Versus Subxiphoid Procedure

• Sponsor: The Second Hospital of Shandong University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04223466
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 95.8
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

Surgerys used in thymectomy for myasthenia gravis and anterior mediastinal tumours have become much less invasive in recent years. In our study, the surgical technique which resected the thymus below the xiphoid process and the technique which was regarded as conventional video- assisted thoracoscopic surgery (VATS) thymectomy was compared.

Condition or Disease	Intervention/Treatment	Phase
Thymectomy	Procedure: Subxiphoid surgery procedure; Procedure: VATS surgery procedure	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Video-assisted Thoracoscopic Thymectomy Versus Subxiphoid Thymectomy: Short- Term and Long- Term Results
• Anticipated Study Start Date: Jan 7, 2020
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Dec 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Subxiphoid group Subxiphoid procedure for thymectomy.	Procedure: Subxiphoid surgery procedure; Subxiphoid procedure for thymectomy
Active Comparator: VATS group Video-assisted thoracoscopic thymectomy through chest wall.	Procedure: VATS surgery procedure; VATS procedure for thymectomy

Outcome Measures

Primary Outcome Measures

1. Visual Analogue Scale of postoperative pain [within 3 days]

   in score

2. Operation time [one day]

   in minutes

3. The amount of blood loss [one day]

   in milliliter

4. Duration of drainage [with 7 days]

   in days

5. Duration of hospital stay [with 7 days]

   in days

Secondary Outcome Measures

1. Complete remission rates [5 years]

   Complete remission rates after 5 year follow-up of thymectomy for myasthenia gravis

2. Recurrence rate [5 years]

   Recurrence rate after 5 year follow-up of thymectomy for thymoma

3. Overall survival [within 10 years]

   Overall survival in rate

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Thymoma with or without myasthenia gravis；

2. Generalized myasthenia gravis not sensitive to conservative medicine treatment;

3. Good cardiopulmonary function.

Exclusion Criteria:

1. Cardiopulmonary function can't bear surgery;

2. Generalized myasthenia gravis with MuSK(+).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yunpeng	Jinan	Shandong	China	250033

Sponsors and Collaborators

• The Second Hospital of Shandong University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Second Hospital of Shandong University
• ClinicalTrials.gov Identifier: NCT04223466
• Other Study ID Numbers: Subxiphoid ZYP1
• First Posted: Jan 10, 2020
• Last Update Posted: Jan 10, 2020
• Last Verified: Jan 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by The Second Hospital of Shandong University: Video-assisted thoracoscopic surgery; Subxiphoid approach

Study Results

No Results Posted as of Jan 10, 2020