NCT04223466

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Jan 2020Dec 2027

Study Start

First participant enrolled

January 7, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 8, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 10, 2020

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

November 16, 2022

Status Verified

November 1, 2022

Enrollment Period

5 years

First QC Date

January 8, 2020

Last Update Submit

November 14, 2022

Conditions

Thymectomy

Keywords

Video-assisted thoracoscopic surgerySubxiphoid approach

Outcome Measures

Primary Outcomes (5)

  • Visual Analogue Scale of postoperative pain

    in score

    within 3 days

  • Operation time

    in minutes

    one day

  • The amount of blood loss

    in milliliter

    one day

  • Duration of drainage

    in days

    with 7 days

  • Duration of hospital stay

    in days

    with 7 days

Secondary Outcomes (3)

  • Complete remission rates

    5 years

  • Recurrence rate

    5 years

  • Overall survival

    within 10 years

Study Arms (2)

Subxiphoid group

EXPERIMENTAL

Subxiphoid procedure for thymectomy.

Procedure: Subxiphoid surgery procedure

VATS group

ACTIVE COMPARATOR

Video-assisted thoracoscopic thymectomy through chest wall.

Procedure: VATS surgery procedure

Interventions

Subxiphoid surgery procedurePROCEDURE

Subxiphoid procedure for thymectomy

Subxiphoid group
VATS surgery procedurePROCEDURE

VATS procedure for thymectomy

VATS group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Thymoma with or without myasthenia gravis；
  • Generalized myasthenia gravis not sensitive to conservative medicine treatment;
  • Good cardiopulmonary function.

You may not qualify if:

  • Cardiopulmonary function can't bear surgery;
  • Generalized myasthenia gravis with MuSK(+).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yunpeng

Jinan, Shandong, 250033, China

RECRUITING

Central Study Contacts

Yunpeng Zhao

CONTACT

+8618766188692zyp_baggio@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2020

First Posted

January 10, 2020

Study Start

January 7, 2020

Primary Completion

December 31, 2024

Study Completion (Estimated)

December 31, 2027

Last Updated

November 16, 2022

Record last verified: 2022-11

Locations

CN(1)