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

Primary Purpose

Non Small Cell Lung Cancer

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Uniportal VATS

Conventional VATS

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring CVATS, UVATS, perioperative effect, ergonomic influence

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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;

Sites / Locations

The second affiliated hospital Zhejiang university school of medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional VATS

Uniportal VATS

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

lung function

lung function will be measured at pre-operative, 3 weeks, 3 months after surgery

Pain Scores after surgery

Pain Scores will be measured by Brief pain inventory

The surgeon's ergonomic influence during operation(blinks/min)

Spontaneous eye blink rate(NASA Task Load Index，NASA TLX)

Full Information

NCT ID

NCT02462356

First Posted

May 27, 2015

Last Updated

April 14, 2016

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT02462356

Brief Title

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

Acronym

MVUVLC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Unknown status

Study Start Date

December 2015 (undefined)

Primary Completion Date

September 2016 (Anticipated)

Study Completion Date

September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non Small Cell Lung Cancer

Keywords

CVATS, UVATS, perioperative effect, ergonomic influence

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Conventional VATS

Arm Type

Active Comparator

Arm Description

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

Arm Title

Uniportal VATS

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Uniportal VATS

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Conventional VATS

Intervention Description

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

Primary Outcome Measure Information:

Title

short-term quality of life(EQ5D) between the two groups

Description

To observe differences of short-term effects(bleeding volume during operation,operation time, hospital mortality, hospital stay and so on) between two groups.

Time Frame

Up to 6 month

Secondary Outcome Measure Information:

Title

intra-operative and postoperative complications

Description

Surgical Complications include conversion rate, bleeding, air leakage, pain, cardiac arrhythmias, wound infection, pulmonary complications, pulmonary function will be measured.

Time Frame

form the day of surgery up to discharege (expected within 1 month)

Title

lung function

Description

lung function will be measured at pre-operative, 3 weeks, 3 months after surgery

Time Frame

pre-operative, 3 weeks, 3 months after surgery

Title

Pain Scores after surgery

Description

Pain Scores will be measured by Brief pain inventory

Time Frame

1, 3 days and 1, 3 months after surgery

Title

The surgeon's ergonomic influence during operation(blinks/min)

Description

Spontaneous eye blink rate(NASA Task Load Index，NASA TLX)

Time Frame

The video is capture every 5 minutes and lasted for 1 minute

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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;

Facility Information:

Facility Name

The second affiliated hospital Zhejiang university school of medicine

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310000

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

33080728

Citation

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.

Results Reference

derived

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

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