RCT of Uniport VATS for Lung Cancer

NCT ID: NCT04212481

Last Updated: 2022-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-25

Study Completion Date

2025-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Single-port Video-assisted Thoracoscopic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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single port group

Uniport video-assisted thoracoscopic surgery for NSCLC

Group Type EXPERIMENTAL

uniport video-assisted thoracoscopic surgery

Intervention Type PROCEDURE

video-assisted thoracoscopic surgery for NSCLC using single port or two ports or three ports

two ports group

video-assisted thoracoscopic surgery for NSCLC using two ports

Group Type ACTIVE_COMPARATOR

two ports video-assisted thoracoscopic surgery

Intervention Type PROCEDURE

video-assisted thoracoscopic surgery for NSCLC using two ports

three ports group

video-assisted thoracoscopic surgery for NSCLC using three ports

Group Type ACTIVE_COMPARATOR

three ports video-assisted thoracoscopic surgery

Intervention Type PROCEDURE

video-assisted thoracoscopic surgery for NSCLC using three ports

Interventions

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uniport video-assisted thoracoscopic surgery

video-assisted thoracoscopic surgery for NSCLC using single port or two ports or three ports

Intervention Type PROCEDURE

two ports video-assisted thoracoscopic surgery

video-assisted thoracoscopic surgery for NSCLC using two ports

Intervention Type PROCEDURE

three ports video-assisted thoracoscopic surgery

video-assisted thoracoscopic surgery for NSCLC using three ports

Intervention Type PROCEDURE

Eligibility Criteria

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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;
Minimum Eligible Age

25 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Second Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiaogang Zhao, Doctor

Role: STUDY_DIRECTOR

The Second Hospital of Shandong University

Locations

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The Second Hospital of Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yunpeng Zhao, Doctor

Role: CONTACT

+8618766188692

Facility Contacts

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Yunpeng Zhao, doctor

Role: primary

+8618766188692

Other Identifiers

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Uniport VATS ZYP1

Identifier Type: -

Identifier Source: org_study_id

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