Condition category
Cancer
Date applied
01/11/2017
Date assigned
15/11/2017
Last edited
13/11/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
NSCLC (non-small cell lung cancer) describes different types of lung cancer. There is no convincing evidence that dissection(removal) of the pulmonary ligament (part of the lung) in an upper lobectomy (a type of surgery where one lobe of the lung is removed) significantly improves outcomes and reduces complications than leaving it intact. This study uses video-assisted thoracic surgery to help with the procedure. This study was designed to testify whether preservation of the pulmonary ligament can provide better pulmonary function and quality of life when compared with division this ligament for patients undergoing video-assisted thoracic surgery upper lobectomy.

Who can participate?
Adults aged 18-80 years old who have never underwent thoracic surgery before diagnosed with upper lobe (NSCLC).

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group have their pulmonary ligament preserved. Those in the second group have the inferior pulmonary ligament divided during video-assisted thoracic surgery upper lobectomy. In the preservation of the pulmonary ligament (PPL) group, patients are allocated to receive video-assisted thoracic surgery (VATS) upper lobectomy which preserving the pulmonary ligament. In the division of the pulmonary ligament (DPL) group, patients are allocated to receive video-assisted thoracic surgery (VATS) upper lobectomy which divides the pulmonary ligament. Postoperative pulmonary function test and quality of life scale are assessed three to six months after the operation.

What are the possible benefits and risks of participating?
Participants may benefit from better pulmonary function and quality of life. The possible risk is that the treatment may fail promote pulmonary function when compare with division of the pulmonary ligament (DPL) group.

Where is the study run from?
Second Affiliated Hospital of Zhejiang University (China)

When is the study starting and how long is it expected to run for?
November 2017 to May 2019

Who is funding the study?
Second Affiliated Hospital of Zhejiang University School of Medicine (China)

Who is the main contact?
Professor Ming Wu

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ming Wu

ORCID ID

Contact details

Department of Thoracic Surgery
The Second Affiliated Hospital of Zhejiang University
Hangzhou
310000
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NA

Study information

Scientific title

Preservation of the pulmonary ligament during video-assisted thoracic surgery upper lobectomy provide less pulmonary function damage and better quality of life for patients after operation than division of the pulmonary ligament

Acronym

Study hypothesis

The aim of this study is examine whether preservation of the pulmonary ligament can provide better pulmonary function and quality of life when compared with division this ligament for patients undergoing video-assisted thoracic surgery upper lobectomy.

Ethics approval

Ethics Committee of the Second Affiliated Hospital of Zhejiang University, 23/10/2017

Study design

Single-center randomised study conduct to compare preservation of the pulmonary ligament with division of the pulmonary ligament about postoperative pulmonary function and quality of life for patients undergoing video-assisted thoracic surgery upper lobectomy.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Postoperative pulmonary function and quality of life of non-small cell lung cancer (NSCLC) patients who undergoing video-assisted thoracic surgery (VATS) upper lobectomy will performed 3 months to 6 months after operation

Intervention

Participants are randomly allocated to one of two groups.

In the preservation of the pulmonary ligament (PPL) group, patients are allocated to receive video-assisted thoracic surgery (VATS) upper lobectomy which preserving the pulmonary ligament.

In the division of the pulmonary ligament (DPL) group, patients are allocated to receive video-assisted thoracic surgery (VATS) upper lobectomy which dividing the pulmonary ligament.

Postoperative pulmonary function and quality of life of patients is assessed three to six months after operation for both groups.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

1. Postoperative pulmonary function is measured using the variation of indicators in pulmonary function test between preoperation and postoperation at three to six months after the operation
2. Quality of life is measured using two standard questionnaires: the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ–C30) and its lung cancer supplementary questionnaire (QLQ–LC13) at three to six months after the operation

Secondary outcome measures

1. Complications after surgery is measured using patient notes after surgery and before discharge
2. Chest tube duration(whether thoracocentesis) is measured using patient notes after surgery and before discharge
3. The number of patients who are capable of a good cough is measured using patient notes on postoperative days one, two and three
4. Total hospital stay is measured using patient notes on discharge
5. Time in the ICU is measured using patient notes on discharge
6. Mortality within 30 days after surgery

Overall trial start date

01/11/2017

Overall trial end date

31/05/2019

Reason abandoned

Eligibility

Participant inclusion criteria

Patients who never have underwent thoracic surgery and chemotherapy before diagnosed with upper lobe non-small cell lung cancer (NSCLC) are deemed suitable for single intercostal video assisted thoracic surgery.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

about 60 patients in each group

Participant exclusion criteria

1. Unresectable tumors
2. Older than 80-years-old
3. Deemed suitable for chemotherapy after surgery

Recruitment start date

30/11/2017

Recruitment end date

30/11/2018

Locations

Countries of recruitment

China

Trial participating centre

Second Affiliated Hospital of Zhejiang University
The Thoracic Surgery Department
Hangzhou
310000
China

Sponsor information

Organisation

The Thoracic Surgery of the Second Affiliated Hospital of Zhejiang University

Sponsor details

No. 88 Jiefang road
Zhejiang Province
Hangzhou
310000
China

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Second Affiliated Hospital of Zhejiang University School of Medicine (China)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal and intent to publish date around one year after our overall trial end date.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Shuai Fang at 964730338@qq.com.

Intention to publish date

31/05/2020

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes