Curative Effect and Quality of Life Between Uniportal and Open Sleeve Lobectomy for Central Type Lung Cancer

NCT03523468 | Unknown Phase 3

• 1 other identifier: jianglei3
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

In surgical treatment decisions, locally advanced central lung cancer is the most difficult. When infiltrating into the trachea, conventional pneumonectomy cannot achieve the purpose of radical treatment.Pulmonary sleeve resection involves the removal of part of the main bronchus and can completely remove the tumor, as far as possible to retain normal lung function, fully embodies the surgical principle and is worthy of clinical promotion.this study intends to compare uniportal-sleeve and open-chest sleeve lobectomy for the treatment of central lung cancer, analyzing the curative effect and quality of life of postoperative patients on the basis of previous accumulation.

Conditions

Video-Assisted Thoracic Surgery; Lung Cancer

Keywords

VATS; Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Postoperative pain

  visual analogue score (VAS-score) is to asses the development of acute and chronic pain after VATS surgery. 11 point numeric rating scale of 0 represented "no pain"and a score of 10 represented "worst pain ".

  6 months

• Quality of life

  EORTC QLQ-C43 questionnaire is used.

  6 months

Secondary Outcomes (1)

• 5 year survival

  5 years

Study Arms (2)

uniportal sleeve lobectomy

EXPERIMENTAL

locally advanced central lung cancer resection by uniportal VATS sleeve lobectomy

Procedure: uniportal sleeve lobectomy

open sleeve lobectomy

ACTIVE COMPARATOR

locally advanced central lung cancer resection by open chest sleeve lobectomy

Procedure: open sleeve lobectomy

Interventions

uniportal sleeve lobectomy PROCEDURE

central lung cancer sleeve resection performed by uniportal VATS

uniportal sleeve lobectomy

open sleeve lobectomy PROCEDURE

central lung cancer sleeve resection performed by open chest

open sleeve lobectomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The tumor is located in the opening of bronchus, or the edge of the tumor is \<2 cm away from the opening of the bronchi;
• The distance between the edge of the tumor and the carina is \>1.5 cm;
• Partial benign lesions or the presence of bronchial stenosis Patient.

You may not qualify if:

• Distant metastasis;
• Cardiopulmonary function cannot tolerate surgery.

Sponsors & Collaborators

• Lei Jiang: lead
• Shanghai Pulmonary Hospital, Shanghai, China: collaborator

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, 200020, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 2, 2018
• First Posted: May 14, 2018
• Study Start: May 15, 2018
• Primary Completion: May 30, 2024
• Study Completion: December 30, 2024
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

CN (1)