Perioperative complication management protocol for lung cancer ablation
| ISRCTN | ISRCTN65169553 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65169553 |
- Submission date
- 21/07/2025
- Registration date
- 23/07/2025
- Last edited
- 22/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Perioperative complication management is a crucial component of lung cancer ablation, directly related to surgical outcomes and patient prognosis. Existing complication management methods have shortcomings in practical application, such as non-standardized management procedures, incomplete monitoring indicators, and the lack of targeted interventions, resulting in unsatisfactory complication rates and treatment outcomes. This study aims to develop a perioperative complication management protocol for lung cancer ablation to reduce the incidence of perioperative complications and evaluate its application effects.
Who can participate?
Lung cancer patients undergoing ablation
What does the study involve?
The control group received routine management; the experimental group received management using the constructed perioperative complication management protocol for lung cancer ablation.
What are the possible benefits and risks of participating?
The perioperative complication management protocol for lung cancer ablation constructed will improve quality of life and satisfaction, effectively reduce the incidence of perioperative complications, and alleviate patients' psychological pressure.
This protocol is not yet able to predict possible complications that may occur.
Where is the study run from?
Tongji University Affiliated Shanghai Pulmonary Hospital, China
When is the study starting and how long is it expected to run for?
September 2022 to October 2024
Who is funding the study?
The Three-Year Action Plan Project for Discipline Construction of Tongji University School of Nursing, China
Who is the main contact?
Dr Lihua Huang, huanglh2025lh@163.com
Contact information
Public, Scientific, Principal Investigator
Shanghai Pulmonary Hospital affiliated to Tongji University
No. 507 Zhengmin Road, Yangpu District
Shanghai
200000
China
| Phone | +86-02165115006 |
|---|---|
| huanglh2025lh@163.com |
Study information
| Study design | Single-centre interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospice, Hospital, Medical and other records |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Construction and application of perioperative complication management protocol for lung cancer ablation |
| Study objectives | To construct a perioperative complication management protocol for lung cancer ablation and evaluate its application effects. |
| Ethics approval(s) |
Approved 28/10/2022, Shanghai Pulmonary Hospital Ethics Review Committee (No. 507 Zhengmin Road, Shanghai, 200000, China; +86-02165115006; Xuxiaoyan98@21cn.com), ref: Q22-368Y |
| Health condition(s) or problem(s) studied | Scientific management of perioperative complications in patients undergoing lung cancer ablation |
| Intervention | The control group received routine management, and the experimental group received management using the constructed perioperative complication management protocol for lung cancer ablation. The method of randomisation involved using the coin flip method. Ward 4 of the Oncology Department was determined as the control group and Ward 2 as the experimental group. The control group received routine management: Preoperatively, the responsible nurse informed patients about lung cancer ablation methods and precautions; the importance of intraoperative cooperation and compliance; medical staff were responsible for observing and managing adverse events or complications during surgery, with image acquisition and scanning supervised by other CT room technicians; postoperatively, patients returned to the ward where responsible nurses closely observed vital sign changes and complication occurrence, such as hemoptysis, respiration, heart rate, blood pressure indicators, and chest tightness or dyspnea discomfort; patients received telephone follow-up every 3 months after discharge. The experimental group received management using the constructed perioperative complication management protocol for lung cancer ablation as follows: 1. Establishment of multidisciplinary team: A perioperative complication management team for lung cancer ablation was established, consisting of nursing, ablation, rehabilitation, and psychological nursing groups 2. Clarification of team member responsibilities: 2.1. Nursing group: Responsible for pre- and postoperative patient care and health education, assisting with intraoperative supplies preparation and monitoring (closely observing for hypotension, chest tightness, dyspnea symptoms, monitoring for pneumothorax, bleeding complications, promptly notifying physicians, cooperating with emergency care when necessary) 2.2. Ablation group: Responsible for CT imaging, image analysis, lesion measurement, puncture site positioning, image post-processing, developing needle insertion paths, and performing lung cancer ablation 2.3. Rehabilitation group: Team members developed individualized perioperative rehabilitation plans based on patient conditions before enrollment 2.4. Psychological nursing group: Team members developed individualized psychological intervention plans based on actual patient conditions before enrollment. All personnel received unified training and assessment from senior staff within the research team, with all team members passing assessment. 3. Protocol implementation: The research team leader established a WeChat group and supervised and maintained its operation; responsible nurses conducted preoperative breathing training according to surgical requirements until patients could perform command breathing cooperation, contacted the multidisciplinary team by phone for perioperative preparation; work groups used the WeChat platform to establish contact, cooperate with each other, and timely understand surgical progress and patient conditions: the ablation group reported preoperative preparation or patient surgical process to the ward; responsible nurses reported postoperative patient conditions; during puncture by the ablation group, nurses cooperated with supply transfer, intraoperative patient guidance, and postoperative complication observation and management; responsible nurses conducted telephone follow-up every 3 months after patient discharge, inquiring, guiding, and answering relevant questions for their assigned patients. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Perioperative complication incidence (perioperative complication incidence = total number of perioperative complications / total number of lung cancer ablation patients) at 3 months after surgery measured using study data collected from case report forms 2. Quality of life measured using Functional Assessment of Cancer Therapy-General (FACT-G) scale before intervention and 3 months after surgery 3. Patient Satisfaction measured using a self-designed satisfaction questionnaire (Satisfaction rate for each group = (very satisfied + satisfied) / total cases in each group × 100%) at 3 months after surgery 4. Preoperative Anxiety Level using a Self-rating Anxiety Scale before surgery |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/09/2022 |
| Completion date | 31/10/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 54 Years |
| Upper age limit | 77 Months |
| Sex | Both |
| Target number of participants | 272 |
| Total final enrolment | 269 |
| Key inclusion criteria | 1. Patients meeting lung tumor diagnostic criteria scheduled for elective lung cancer ablation treatment 2. Clear consciousness, normal thinking, able to communicate verbally and in writing 3. Cooperative with the study and signed informed consent |
| Key exclusion criteria | 1. Severe bleeding tendency, platelets <50×10⁹/L and uncorrectable coagulation disorders (prothrombin time >18s, prothrombin activity <40%), anticoagulation therapy and/or antiplatelet drugs discontinued for less than 5-7 days before ablation 2. Severe comorbidities, infection period, immunocompromised, renal insufficiency 3. Cardiac pacemaker implantation, metal implants 4. Eastern Cooperative Oncology Group (ECOG) performance status score >3 |
| Date of first enrolment | 01/12/2023 |
| Date of final enrolment | 31/05/2024 |
Locations
Countries of recruitment
- China
Study participating centre
Shanghai
200000
China
Sponsor information
Hospital/treatment centre
No. 507 Zhengmin Road, Yangpu District
Shanghai
200000
China
| Phone | +86-02165115009 |
|---|---|
| Xuxiaoyan98@21cn.com | |
| Website | https://med.tongji.edu.cn/english/HOME.htm |
"ROR" |
https://ror.org/033nbnf69 |
Funders
Funder type
University/education
Government organisation / Local government
- Location
- China
Results and Publications
| Intention to publish date | 01/07/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
21/07/2025: Study's existence confirmed by the Shanghai Pulmonary Hospital Ethics Review Committee, China.
