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RCT of Uniport VATS for Lung Cancer

Primary Purpose

Single-port Video-assisted Thoracoscopic Surgery

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
uniport video-assisted thoracoscopic surgery
two ports video-assisted thoracoscopic surgery
three ports video-assisted thoracoscopic surgery
Sponsored by
The Second Hospital of Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Single-port Video-assisted Thoracoscopic Surgery focused on measuring Non Small Cell Lung Cancer, Perioperative Efficacy, multi-port

Eligibility Criteria

25 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • The Second Hospital of Shandong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

single port group

two ports group

three ports group

Arm Description

Uniport video-assisted thoracoscopic surgery for NSCLC

video-assisted thoracoscopic surgery for NSCLC using two ports

video-assisted thoracoscopic surgery for NSCLC using three ports

Outcomes

Primary Outcome Measures

operative time
operative time in minutes
perioperative blood loss
perioperative blood loss in milliliter
conversion rate
conversion rate in proportion
duration of postoperative drainage
duration of postoperative drainage in days
length of hospital stay
length of hospital stay in days
visual analogue score of postoperative pain
score
complications
complications in rate

Secondary Outcome Measures

overall survival
overall survival in rate
progression- free survival
progression- free survival in rate

Full Information

First Posted
December 21, 2019
Last Updated
November 14, 2022
Sponsor
The Second Hospital of Shandong University
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1. Study Identification

Unique Protocol Identification Number
NCT04212481
Brief Title
RCT of Uniport VATS for Lung Cancer
Official Title
Randomized Controlled Trial of the Comparison of Uniport VATS and Non- Uniport VATS for Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 25, 2019 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Second Hospital of Shandong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Single-port Video-assisted Thoracoscopic Surgery
Keywords
Non Small Cell Lung Cancer, Perioperative Efficacy, multi-port

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
single port group
Arm Type
Experimental
Arm Description
Uniport video-assisted thoracoscopic surgery for NSCLC
Arm Title
two ports group
Arm Type
Active Comparator
Arm Description
video-assisted thoracoscopic surgery for NSCLC using two ports
Arm Title
three ports group
Arm Type
Active Comparator
Arm Description
video-assisted thoracoscopic surgery for NSCLC using three ports
Intervention Type
Procedure
Intervention Name(s)
uniport video-assisted thoracoscopic surgery
Intervention Description
video-assisted thoracoscopic surgery for NSCLC using single port or two ports or three ports
Intervention Type
Procedure
Intervention Name(s)
two ports video-assisted thoracoscopic surgery
Intervention Description
video-assisted thoracoscopic surgery for NSCLC using two ports
Intervention Type
Procedure
Intervention Name(s)
three ports video-assisted thoracoscopic surgery
Intervention Description
video-assisted thoracoscopic surgery for NSCLC using three ports
Primary Outcome Measure Information:
Title
operative time
Description
operative time in minutes
Time Frame
1 day
Title
perioperative blood loss
Description
perioperative blood loss in milliliter
Time Frame
1 day
Title
conversion rate
Description
conversion rate in proportion
Time Frame
1 day
Title
duration of postoperative drainage
Description
duration of postoperative drainage in days
Time Frame
within 5-7 days
Title
length of hospital stay
Description
length of hospital stay in days
Time Frame
within 5-7 days
Title
visual analogue score of postoperative pain
Description
score
Time Frame
within 5-7 days
Title
complications
Description
complications in rate
Time Frame
up to 3 months
Secondary Outcome Measure Information:
Title
overall survival
Description
overall survival in rate
Time Frame
up to 5 years
Title
progression- free survival
Description
progression- free survival in rate
Time Frame
up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yunpeng Zhao, Doctor
Phone
+8618766188692
Email
zyp_baggio@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaogang Zhao, Doctor
Organizational Affiliation
The Second Hospital of Shandong University
Official's Role
Study Director
Facility Information:
Facility Name
The Second Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250033
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunpeng Zhao, doctor
Phone
+8618766188692

12. IPD Sharing Statement

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RCT of Uniport VATS for Lung Cancer

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