MVUVLC: Multiple-portal VATS Versus Uniportal VATS Lobectomy for Non-small Cell Lung Cancer

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02462356

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

7.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer	Procedure: Uniportal VATS Procedure: Conventional VATS	N/A

Detailed Description

Conventional VATS and uniportal VATS lobectomy can be performed each for NSCLC. Conventional VATS lobectomy employ 3 or 4 ports for completing the operation. Usually the camera port is performed at the seventh or eighth intercostals space within the trocar, so it's easy to cause the intercostals nerve and vessel injure, and still create obvious pain.

However, the lobectomy for lung cancer can be accomplished with a single incision. According to the initial results, Uniportal VATS (UVATS) lobectomy procedure has been wide adopted by less acess trauma, relieve postoperative pain. But these were retrospective and descriptive, not randomized study. Further randomized control studies will be required to demonstrate that there are more benefits in UVATS techniques compared with conventional VATS for lobectomy.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

A Randomized Controlled Study: the Effect of Multiple-portal VATS Versus Conventional VATS Lobectomy for NSCLC

Study Start Date :

Dec 1, 2015

Anticipated Primary Completion Date :

Sep 1, 2016

Anticipated Study Completion Date :

Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Conventional VATS Via conventional VATS lobectomy and systematic lymph node dissection for lung cancer	Procedure: Conventional VATS Conventional VATS lobectomy and lymph node dissection will be performed in this group
Experimental: Uniportal VATS Via uniportal VATS lobectomy and systematic lymph node dissection for lung cancer	Procedure: Uniportal VATS Uniportal VATS lobectomy and lymph node dissection will be performed in this group

Arm

Intervention/Treatment

Active Comparator: Conventional VATS

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

Procedure: Conventional VATS

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

Experimental: Uniportal VATS

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

Procedure: Uniportal VATS

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

Outcome Measures

Primary Outcome Measures

short-term quality of life(EQ5D) between the two groups [Up to 6 month]
To observe differences of short-term effects(bleeding volume during operation,operation time, hospital mortality, hospital stay and so on) between two groups.

Secondary Outcome Measures

intra-operative and postoperative complications [form the day of surgery up to discharege (expected within 1 month)]
Surgical Complications include conversion rate, bleeding, air leakage, pain, cardiac arrhythmias, wound infection, pulmonary complications, pulmonary function will be measured.
lung function [pre-operative, 3 weeks, 3 months after surgery]
lung function will be measured at pre-operative, 3 weeks, 3 months after surgery
Pain Scores after surgery [1, 3 days and 1, 3 months after surgery]
Pain Scores will be measured by Brief pain inventory
The surgeon's ergonomic influence during operation(blinks/min) [The video is capture every 5 minutes and lasted for 1 minute]
Spontaneous eye blink rate(NASA Task Load Index，NASA TLX)

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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;