A randomized clinical trial to assess the postoperative pulmonary function and quality of life of preservation of the pulmonary ligament versus division of the pulmonary ligament for patients undergoing video-assisted thoracic surgery upper lobectomy

ISRCTN	ISRCTN69425940
DOI	https://doi.org/10.1186/ISRCTN69425940
Protocol serial number	NA
Sponsor	The Thoracic Surgery of the Second Affiliated Hospital of Zhejiang University
Funder	Second Affiliated Hospital of Zhejiang University School of Medicine (China)

Submission date: 01/11/2017
Registration date: 15/11/2017
Last edited: 29/04/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Prof Ming Wu
Scientific

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

Study information

Primary study design	Interventional
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.
Secondary study design	Randomised controlled trial
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
Study objectives	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(s)	Ethics Committee of the Second Affiliated Hospital of Zhejiang University, 23/10/2017
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	31/12/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	120
Key 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.
Key exclusion criteria	1. Unresectable tumors 2. Older than 80-years-old 3. Deemed suitable for chemotherapy after surgery
Date of first enrolment	30/11/2017
Date of final enrolment	31/07/2019

Locations

Countries of recruitment

China

Study participating centre

Second Affiliated Hospital of Zhejiang University

The Thoracic Surgery Department
Hangzhou
310000
China

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Shuai Fang at 964730338@qq.com.

Editorial Notes

29/04/2019: The following changes were made:
1. The recruitment end date was updated from 30/11/2018 to 31/07/2019.
2. The overall trial end date was updated from 31/05/2019 to 31/12/2019.