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

NCT ID: NCT02462356

Last Updated: 2016-04-15

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-09-30

Brief Summary

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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

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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.

Conditions

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Non Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Conventional VATS

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

Group Type ACTIVE_COMPARATOR

Conventional VATS

Intervention Type PROCEDURE

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

Uniportal VATS

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

Group Type EXPERIMENTAL

Uniportal VATS

Intervention Type PROCEDURE

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

Interventions

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Uniportal VATS

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

Intervention Type PROCEDURE

Conventional VATS

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

Intervention Type PROCEDURE

Eligibility Criteria

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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;
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Junqiang Fan

Thoracic Surgery Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The second affiliated hospital Zhejiang university school of medicine

Hangzhou, Zhejiang, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 33080728 (View on PubMed)

Other Identifiers

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LY15H160034

Identifier Type: -

Identifier Source: org_study_id

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