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

Non Small Cell Lung Cancer Clinical Trial

— MVUVLC  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02462356
• Other study ID #: LY15H160034
• Status: Enrolling by invitation
• Phase: N/A
• First received: May 27, 2015
• Last updated: April 14, 2016
• Start date: December 2015
• Est. completion date: September 2016

Study information

• Verified date: April 2016
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 70
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Procedure:
• Uniportal VATS
Uniportal VATS lobectomy and lymph node dissection will be performed in this group
• Conventional VATS
Conventional VATS lobectomy and lymph node dissection will be performed in this group

Locations

Country	Name	City	State
China	The second affiliated hospital Zhejiang university school of medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	lung function	lung function will be measured at pre-operative, 3 weeks, 3 months after surgery	pre-operative, 3 weeks, 3 months after surgery
Secondary	Pain Scores after surgery	Pain Scores will be measured by Brief pain inventory	1, 3 days and 1, 3 months after surgery
Secondary	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