Single-port, Two-port Versus Three-port VATS on Non-small Cell Lung Cancer

NCT02992353 | Unknown DMC

• 1 other identifier: Z161100000116044
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 1

Brief Summary

In china, the incidence and death rate of lung cancer is 48.32 per 100 000 person-years and 39.27 per 100 000 person-years, respectively, the highest in malignant tumor. Surgical operation is still main treatment means to resectable NSCLC. VATS pulmonary resection is performed in clinical operation with the aim of decreasing postoperative complications morbidity. The mechanisms may be due to minimize the inflammation reaction to surgical injury. There are some trials regarding two-port VATS versus three-port VATS versus four-port VATS or single-port VATS versus three-port VATS. However, there is no prospective randomised controlled trial regarding Single-port versus two-port versus three-port video assisted thoracoscopic pulmonary resection on NSCLC. So, we hope to demonstrate that single-port and two-port VATS were feasible and safe through the trial, and we hope the results of our study will provide a high level of clinical evidence for choosing the best operative approach in VATS.

Conditions

Lung Neoplasm

Keywords

VATS; NSCLC; recurrence rate

Outcome Measures

Primary Outcomes (1)

• Local recurrence

  two-year local recurrence rate after surgery

  2 years

Secondary Outcomes (3)

• Postoperative respiratory complications

  30 days after surgery

• Lymph node dissection

  Intraoperation

• Blood loss

  Intraoperation

Study Arms (2)

Three-port 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: Three-port pulmonary resection surgery

Single-port or two-port surgery

ACTIVE COMPARATOR

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

Procedure: Single-port or two-port surgery

Interventions

Three-port pulmonary resection surgery PROCEDURE

Three-port pulmonary resection surgery

Three-port pulmonary resection surgery

Single-port or two-port surgery PROCEDURE

Single-port or two-port pulmonary resection surgery

Single-port or two-port surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 18 and 80 years;
• cT1-3N0-1M0 diagnosed by chest CT or PET-CT before operation;
• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital of Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 110000, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Juwei Mu, MD

  Beijing Municipal Science & Technology Commission

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juwei Mu, MD

CONTACT

8610-87788495; mujuwei@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: December 12, 2016
• First Posted: December 14, 2016
• Study Start: July 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: December 14, 2016

Record last verified: 2016-12

Locations

CN (1)