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

Sponsor
Lei Jiang (Other)
Overall Status
Recruiting
CT.gov ID
NCT03523468
Collaborator
Shanghai Pulmonary Hospital, Shanghai, China (Other)
200
1
2
55.5
3.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: uniportal sleeve lobectomy
  • Procedure: open sleeve lobectomy
Phase 3

Detailed Description

In surgical treatment decisions, locally advanced central lung cancer is the most difficult. Locally advanced central lung cancer refers to tumors that have recidivised adjacent organs and tissues, such as the esophagus, tracheal carina, pericardium, heart, large vessels, etc., with mediastinal lymph node metastases, but no distant metastases (such as bone) have been found by current examination methods. Adjacent hilar lymph nodes and blood vessels are easily invaded, so it is difficult to perform surgery and the resection rate is low. On the other hand, central lung cancer involving the opening of the main bronchus and upper lobe often requires pneumonectomy which would affect the quality of life. When infiltrating into the trachea, conventional pneumonectomy cannot achieve the purpose of radical treatment. The accepted principle of surgery is to maximize the removal of tumor tissue and to maximize the retention of healthy lung tissue. 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 this surgical principle and is worthy of clinical promotion.

patients who are suitable for sleeve resection account for 5% to 13% of the total surgical volume. This also expands the indications for Video assisted thoracoscopic surgery (VATS). Some central lung cancer patients therefore could benefit from that, especially for elderly patients with poor cardiopulmonary function. However, central lung cancer sleeve resection performed by uniportal VATS is seldom reported, and it has been considered as a difficult and high-risk surgical method.

The Investigators' hospital has completed more than 300 cases of uniportal sleeve surgery, which has become the largest center for performing sleeve-surgery by uniportal VATS in the world.

Therefore, 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. The Investigators' work would promote the usage of uniportal-sleeve lobectomy in the treatment of patients with locally advanced central lung cancer.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Curative Effect and Quality of Life Between Uniportal Sleeve Lobectomy and Open-chest Sleeve Lobectomy for Central Type Lung Cancer: a Prospective Randomized Controlled Study
Actual Study Start Date :
May 15, 2018
Anticipated Primary Completion Date :
May 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: uniportal sleeve lobectomy

locally advanced central lung cancer resection by uniportal VATS sleeve lobectomy

Procedure: uniportal sleeve lobectomy
central lung cancer sleeve resection performed by uniportal VATS

Active Comparator: open sleeve lobectomy

locally advanced central lung cancer resection by open chest sleeve lobectomy

Procedure: open sleeve lobectomy
central lung cancer sleeve resection performed by open chest

Outcome Measures

Primary Outcome Measures

  1. Postoperative pain [6 months]

    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 ".

  2. Quality of life [6 months]

    EORTC QLQ-C43 questionnaire is used.

Secondary Outcome Measures

  1. 5 year survival [5 years]

    follow up for 5 years

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. 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;

  2. The distance between the edge of the tumor and the carina is >1.5 cm;

  3. Partial benign lesions or the presence of bronchial stenosis Patient.

Exclusion Criteria:
  1. Distant metastasis;

  2. Cardiopulmonary function cannot tolerate surgery.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shanghai Pulmonary Hospital Shanghai China 200020

Sponsors and Collaborators

  • Lei Jiang
  • Shanghai Pulmonary Hospital, Shanghai, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lei Jiang, Principal Investigator, Shanghai Pulmonary Hospital, Shanghai, China
ClinicalTrials.gov Identifier:
NCT03523468
Other Study ID Numbers:
  • jianglei3
First Posted:
May 14, 2018
Last Update Posted:
Oct 19, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Lei Jiang, Principal Investigator, Shanghai Pulmonary Hospital, Shanghai, China
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 19, 2021