NCT02462356

Brief Summary

This study evaluate multiple-portal VATS and uniportal VATS lobectomy for NSCLC, half of participants will receive multiple VATS, while the other half will receive uniportal VATS lobectomy.

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
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2015

Shorter than P25 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

First Submitted

Initial submission to the registry

May 27, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 4, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

April 15, 2016

Status Verified

April 1, 2016

Enrollment Period

9 months

First QC Date

May 27, 2015

Last Update Submit

April 14, 2016

Conditions

Non Small Cell Lung Cancer

Keywords

CVATSUVATSperioperative effectergonomic influence

Outcome Measures

Primary Outcomes (1)

  • short-term quality of life(EQ5D) between the two groups

    To observe differences of short-term effects(bleeding volume during operation,operation time, hospital mortality, hospital stay and so on) between two groups.

    Up to 6 month

Secondary Outcomes (4)

  • intra-operative and postoperative complications

    form the day of surgery up to discharege (expected within 1 month)

  • lung function

    pre-operative, 3 weeks, 3 months after surgery

  • Pain Scores after surgery

    1, 3 days and 1, 3 months after surgery

  • The surgeon's ergonomic influence during operation(blinks/min)

    The video is capture every 5 minutes and lasted for 1 minute

Study Arms (2)

Conventional VATS

ACTIVE COMPARATOR

Via conventional VATS lobectomy and systematic lymph node dissection for lung cancer

Procedure: Conventional VATS

Uniportal VATS

EXPERIMENTAL

Via uniportal VATS lobectomy and systematic lymph node dissection for lung cancer

Procedure: Uniportal VATS

Interventions

Uniportal VATSPROCEDURE

Uniportal VATS lobectomy and lymph node dissection will be performed in this group

Uniportal VATS
Conventional VATSPROCEDURE

Conventional VATS lobectomy and lymph node dissection will be performed in this group

Conventional VATS

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with clinical diagnosis of primary lung cancer with the age between 35 and 75 years old;
  • Patients with Tumor size ≤5cm，clinically staged T1-2N0-1M0，prepared for lobectomy and mediastinal lymph node dissection;
  • Patients with an American Society of Anesthesiology score of 0-1.

You may not qualify if:

  • Patients with N2 or N3 positive or distant metastasis.
  • Patients who had undergone Neoadjuvant chemotherapy.
  • Patients with tumor invasion to the peripheral structures.
  • Patients with previous history of thoracic operations.
  • Patients with serious thoracic adhesion.
  • Patients who will undergo Pneumonectomy, sleeve lobectomy, segmentectomy, wedge resection.
  • Patients with preexisting chronic obstructive pulmonarydisease, asthma, or interstitial lung disease;
  • Patients with cardiac, hepatic, or renal dysfunction;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The second affiliated hospital Zhejiang university school of medicine

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (1)

  • Yao J, Chang Z, Zhu L, Fan J. Uniportal versus multiportal thoracoscopic lobectomy: Ergonomic evaluation and perioperative outcomes from a randomized and controlled trial. Medicine (Baltimore). 2020 Oct 16;99(42):e22719. doi: 10.1097/MD.0000000000022719.

    PMID: 33080728DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Thoracic Surgery Department

Study Record Dates

First Submitted

May 27, 2015

First Posted

June 4, 2015

Study Start

December 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

April 15, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will share

Locations

CN(1)