RCT of Uniport VATS for Lung Cancer

Randomized Controlled Trial of the Comparison of Uniport VATS and Non- Uniport VATS for Lung Cancer

Video-assisted thoracoscopic surgery (VATS) has been widely used for non-small cell lung cancer (NSCLC) for nearly two decades. Usually, it was applied through three ports with at least one drainage after surgery, which often lead to acute chest pain. Therefore, fewer, smaller ports, and wider intercostal space for surgery has been required.

Uniport VATS became a feasible option with the development of surgical techniques and instruments, with potentially less postoperative pain and shorter hospital stays. However, there may be some complications, or with a longer time of operation, even more difficult in lymph nodes resection during learning curve.

In our study, a Randomized Controlled Trial was designed to study the operation time, perioperative blood loss, conversion rate, duration of postoperative drainage, length of hospital stay, visual analogue score of postoperative pain, complications, and survival.

Study Overview

• Status: Recruiting
• Conditions: Single-port Video-assisted Thoracoscopic Surgery
• Intervention / Treatment: Procedure: uniport video-assisted thoracoscopic surgery; Procedure: two ports video-assisted thoracoscopic surgery; Procedure: three ports video-assisted thoracoscopic surgery

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yunpeng Zhao, doctor; Phone Number: +8618766188692; Email: zyp_baggio@163.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250033
      • Recruiting
      • The Second Hospital of Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

patients with cT1-3N0-1M0 NSCLC; good cardiopulmonary function; prepared to undergo radical resection;

Exclusion Criteria:

patients with N3 or M1 NSCLC; poor cardiopulmonary function; not be prepared to undergo radical resection;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: single port group; Uniport video-assisted thoracoscopic surgery for NSCLC	Procedure: uniport video-assisted thoracoscopic surgery; video-assisted thoracoscopic surgery for NSCLC using single port or two ports or three ports
Active Comparator: two ports group; video-assisted thoracoscopic surgery for NSCLC using two ports	Procedure: two ports video-assisted thoracoscopic surgery; video-assisted thoracoscopic surgery for NSCLC using two ports
Active Comparator: three ports group; video-assisted thoracoscopic surgery for NSCLC using three ports	Procedure: three ports video-assisted thoracoscopic surgery; video-assisted thoracoscopic surgery for NSCLC using three ports

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operative time	operative time in minutes	1 day
perioperative blood loss	perioperative blood loss in milliliter	1 day
conversion rate	conversion rate in proportion	1 day
duration of postoperative drainage	duration of postoperative drainage in days	within 5-7 days
length of hospital stay	length of hospital stay in days	within 5-7 days
visual analogue score of postoperative pain	score	within 5-7 days
complications	complications in rate	up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival	overall survival in rate	up to 5 years
progression- free survival	progression- free survival in rate	up to 5 years

Collaborators and Investigators

• Sponsor: The Second Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): December 25, 2019
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): December 30, 2025

Study Registration Dates

• First Submitted: December 21, 2019
• First Submitted That Met QC Criteria: December 25, 2019
• First Posted (Actual): December 27, 2019

Study Record Updates

• Last Update Posted (Actual): November 16, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Non Small Cell Lung Cancer; Perioperative Efficacy; multi-port
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: Uniport VATS ZYP1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No