NCT02933294

Brief Summary

Lung cancer is one of the most common cancers in the world. At present, surgical resection is still the standard treatment for early stage lung cancer. Triportal thoracoscopic lung resection is a routine surgically procedure for early stage lung cancer while uniportal thoracoscopic lung resection is developing rapidly in recent years. Although uniportal VATS pulmonary resection has been proven to be effective in preventing postoperative morbidities, there is still no ample evidences to demonstrate that uniportal VATS pulmonary resection is equal or superior to traditional triportal thoracoscopic pulmonary resection. The purpose of this multicenter randomized controlled trial study is to compare the uniportal VATS with traditional triportal VATS pulmonary resection in postoperative complications, long-term survival, lymph node dissection and local recurrence.

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
356

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

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

May 1, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 14, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

October 14, 2016

Status Verified

October 1, 2016

Enrollment Period

2.9 years

First QC Date

September 23, 2016

Last Update Submit

October 12, 2016

Conditions

Lung Neoplasms

Keywords

uniportallung cancerVATS

Outcome Measures

Primary Outcomes (1)

  • Postoperative respiratory complications

    These respiratory complications involve respiratory distress or failure after the operation with continuation of mechanical ventilation, pulmonary atelectasis requiring sputum suction by bronchoscopy, pneumonia requiring specific antibiotics confirmed by thoracic X-ray or CT scan of the thorax and a positive sputum culture, and acute respiratory distress syndrome.

    30 days after surgery

Secondary Outcomes (5)

  • Blood loss

    Intraoperation

  • Lymph node dissection

    Intraoperation

  • Long term survival

    5 year

  • Local recurrence

    3 years

  • Conversion rate

    Intraoperation

Study Arms (2)

Triportal pulmonary resection surgery

ACTIVE COMPARATOR

Treated by traditional video assisted thoracoscopic three-port pulmonary resection in the centers with enough experience in VATS and the volume ≧50 cases each year.

Procedure: Triportal pulmonary resection surgery

Uniportal pulmonary resection surgery

ACTIVE COMPARATOR

Treated by minimally invasive video assisted thoracoscopic single-port pulmonary resection in the centers with enough experience in VATS and the volume ≧50 cases each year.

Procedure: Uniportal pulmonary resection surgery

Interventions

Triportal pulmonary resection surgeryPROCEDURE

Uniportal video-assisted thoracoscopic surgery

Triportal pulmonary resection surgery
Uniportal pulmonary resection surgeryPROCEDURE

Triportal video-assisted thoracoscopic surgery

Uniportal pulmonary resection surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age≥18 years;
  • cT1- 2N0-1M0 diagnosed by chest CT, PET-CT before operation;
  • No severe comorbidity, can tolerate anesthesia;
  • ECOG PS scores≤2;
  • The patients sign informed consents by themselves.

You may not qualify if:

  • Inability to tolerance of tracheal intubation and general anesthesia;
  • ECOG PS scores\>2;
  • Severe comorbidities including: Angina occurs in 3 months, uncontrolled hypertension, Congestive heart failure, a history of myocardial infarction in 6 months before admission, severe arrhythmia, severe liver, kidney or other metabolic diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 518000, China

RECRUITING

Beijing Chest Hospital

Beijing, 110000, China

RECRUITING

Chinese PLA General Hospital

Beijing, 110000, China

RECRUITING

Fudan University Cancer Center

Shanghai, 200000, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Juwei Mu, MD

    Collaborative Innovation Center for Cancer Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Juwei Mu, MD

CONTACT

8610-87788495mujuwei@cicams.ac.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD，PHD

Study Record Dates

First Submitted

September 23, 2016

First Posted

October 14, 2016

Study Start

May 1, 2015

Primary Completion

April 1, 2018

Study Completion

December 1, 2020

Last Updated

October 14, 2016

Record last verified: 2016-10

Locations

CN(4)