COVIDLungSurg: Coronavirus Infection (COVID-19) and Radical Surgery in Patients With Early-stage Lung Cancer

Ruijin Hospital (Other)
Overall Status
Recruiting ID

Study Details

Study Description

Brief Summary

The goal of this observational study is to learn about the effects of coronavirus infection in patients with early-stage lung cancer. The main question it aims to answer is whether the interval of surgery and COVID-19 infection will affect the surgery and prognosis of the patients.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

Study Design

Study Type:
Anticipated Enrollment :
2000 participants
Observational Model:
Time Perspective:
Official Title:
Effects of Coronavirus Infection (COVID-19) on the Timing and Prognosis of Radical Surgery in Patients With Early-stage Lung Cancer
Actual Study Start Date :
Jan 11, 2023
Anticipated Primary Completion Date :
Aug 11, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
stage I/II lung cancer patients

Patients with stage I/II lung cancer will receive radical surgery.

Other: No intervention
Observational study, no intervention

Outcome Measures

Primary Outcome Measures

  1. postoperative morbidity [postoperative in-hospital stay up to 30 days]

    rate of perioperative complications, mainly include: pneumonia, respiratory failure, pulmonary embolism, arrhythmia, sepsis, cerebrovascular accident, myocardial injury, acute kidney injury.

Secondary Outcome Measures

  1. postoperative hospital stay [postoperative in-hospital stay up to 30 days]

    length of postoperative hospitalization

  2. operation time [At operation day]

    duration of operation

  3. R0 rate [postoperative in-hospital stay up to 30 days]

    R0 resection rate

  4. blood loss [At operation day]

    blood loss in the operation

  5. 30-day mortality [postoperative in-hospital stay up to 30 days]

    30-day mortality after surgery

  6. quality of life [postoperative in-hospital stay up to 30 days]

    postoperative quality of life

Eligibility Criteria


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria:
  • Clinically diagnosed stage I and stage II lung cancer, who are about to receive wedge resection, segmental resection, sleeve resection, lobectomy, or pneumonectomy under general anaesthesia.

  • Volunteer to participate in the study with good compliance. Able to complete the observation and follow-up and have signed the informed consent.

  • ASA score: I-III;

  • Cardiopulmonary functions meet the requirements of radical operation for lung cancer with normal liver and kidney functions.

Exclusion Criteria:
  • Neurologic, mental illness or mental disorder which is hard to control, poor compliance, unable to cooperate or describe the treatment response;

  • Clinically diagnosed stage III and stage IV lung cancer or patients who received neoadjuvant treatment before surgery;

  • Patients developed symptoms alike coronavirus infection but are not confirmed by viral RNA detection by quantitative RT-PCR or antigen testing kits.

  • Serious heart, lung, liver and kidney dysfunction and unable to tolerate the operation

Contacts and Locations


Site City State Country Postal Code
1 Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai Shanghai China 200000

Sponsors and Collaborators

  • Ruijin Hospital


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Hecheng Li M.D., Ph.D, Professor, Ruijin Hospital Identifier:
Other Study ID Numbers:
  • RTS-017
First Posted:
Jan 13, 2023
Last Update Posted:
Jan 13, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Keywords provided by Hecheng Li M.D., Ph.D, Professor, Ruijin Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 13, 2023