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

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

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.

Study Overview

• Status: Unknown
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Procedure: Conventional VATS; Procedure: Uniportal VATS

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 Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • The Second Affiliated Hospital Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): September 1, 2016
• Study Completion (Anticipated): September 1, 2016

Study Registration Dates

• First Submitted: May 27, 2015
• First Submitted That Met QC Criteria: June 1, 2015
• First Posted (Estimate): June 4, 2015

Study Record Updates

• Last Update Posted (Estimate): April 15, 2016
• Last Update Submitted That Met QC Criteria: April 14, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: CVATS; UVATS; perioperative effect; ergonomic influence
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: LY15H160034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES