NCT03051438

Brief Summary

Uniportal video-assisted thoracoscopic surgery (VATS) lobectomy has emerged as a promising and exciting approach for minimally invasive thoracic surgery. However, nearly all reported uniportal VATS lobectomies have been performed via the intercostal route, and chest wall trauma has still occurred. Here,the investigators undertook novel uniportal VATS technique involving a subxiphoid route for pulmonary lobectomies to evaluate the feasibility and advantages.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

January 1, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 13, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

May 24, 2018

Status Verified

May 1, 2018

Enrollment Period

2.4 years

First QC Date

February 7, 2017

Last Update Submit

May 23, 2018

Conditions

LobectomySubxiphoid Uniportal Video-assisted Thoracoscopic Surgery

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

    17 months

Study Arms (2)

Subxiphoid uniportal VATS

OTHER

retrospectively analyzed and compared perioperative data for patients who underwent subxiphoid uniportal and traditional three-port VATS lobectomies

Procedure: Subxiphoid uniportal VATS

Three-port VATS

OTHER

retrospectively analyzed and compared perioperative data for patients who underwent subxiphoid uniportal and traditional three-port VATS lobectomies

Procedure: Three-port VATS

Interventions

Subxiphoid uniportal VATSPROCEDURE

Patients were placed in a supine position, and the operating table was manipulated as needed to elevate the appropriate side of the body for surgery. The surgical procedures followed principles of pulmonary resections; in particular, similar to mediastinal lymphadenectomy for lung cancer, these procedures involved the individual dissection of veins, arteries and lobar bronchi.

Subxiphoid uniportal VATS
Three-port VATSPROCEDURE

The surgical procedures followed principles of pulmonary resections; in particular, similar to mediastinal lymphadenectomy for lung cancer, these procedures involved the individual dissection of veins, arteries and lobar bronchi

Three-port VATS

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with lung cancer can be undertook the subxiphoid uniportal VATS or three-port VATS

You may not qualify if:

  • Contraindications in patients with lung cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shengjing Hospital

Shenyang, Liaoning, 110004, China

Location

Related Publications (7)

  • Liu CC, Wang BY, Shih CS, Lin WC. Subxyphoid single-incision thoracoscopic pulmonary metastasectomy. Thorac Cancer. 2015 Mar;6(2):230-2. doi: 10.1111/1759-7714.12189. Epub 2015 Mar 2.

    PMID: 26273365RESULT

  • Liu CY, Lin CS, Liu CC. Subxiphoid single-incision thoracoscopic surgery for bilateral primary spontaneous pneumothorax. Wideochir Inne Tech Maloinwazyjne. 2015 Apr;10(1):125-8. doi: 10.5114/wiitm.2015.48572. Epub 2015 Jan 27.

    PMID: 25960803RESULT

  • Gonzalez-Rivas D, Yang Y, Lei J, Hernandez L, Jiang G. Subxiphoid uniportal video-assisted thoracoscopic middle lobectomy and anterior anatomic segmentectomy (S3). J Thorac Dis. 2016 Mar;8(3):540-3. doi: 10.21037/jtd.2016.02.63.

    PMID: 27076952RESULT

  • Hernandez-Arenas LA, Lin L, Yang Y, Liu M, Guido W, Gonzalez-Rivas D, Jiang G, Jiang L. Initial experience in uniportal subxiphoid video-assisted thoracoscopic surgery for major lung resections. Eur J Cardiothorac Surg. 2016 Dec;50(6):1060-1066. doi: 10.1093/ejcts/ezw189. Epub 2016 Jul 11.

    PMID: 27401700RESULT

  • Song N, Zhao DP, Jiang L, Bao Y, Jiang GN, Zhu YM, Ding JA. Subxiphoid uniportal video-assisted thoracoscopic surgery (VATS) for lobectomy: a report of 105 cases. J Thorac Dis. 2016 Mar;8(Suppl 3):S251-7. doi: 10.3978/j.issn.2072-1439.2016.02.32.

    PMID: 27014471RESULT

  • Liu CC, Wang BY, Shih CS, Liu YH. Subxiphoid single-incision thoracoscopic left upper lobectomy. J Thorac Cardiovasc Surg. 2014 Dec;148(6):3250-1. doi: 10.1016/j.jtcvs.2014.08.033. Epub 2014 Aug 23. No abstract available.

    PMID: 25240526RESULT

  • Yang X, Wang L, Zhang C, Zhao D, Lu Y, Wang Z. The Feasibility and Advantages of Subxiphoid Uniportal Video-Assisted Thoracoscopic Surgery in Pulmonary Lobectomy. World J Surg. 2019 Jul;43(7):1841-1849. doi: 10.1007/s00268-019-04948-6.

    PMID: 31065773DERIVED

Study Design

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

Study Record Dates

First Submitted

February 7, 2017

First Posted

February 13, 2017

Study Start

January 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

May 24, 2018

Record last verified: 2018-05

Locations

CN(1)