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Clinical Trials/NCT05070026
NCT05070026CompletedNot Applicable

Comparison of Inflammatory Cytokine Levels Between Single-port and Three-port Thoracoscopic Lobectomy in the Treatment of Non-small Cell Lung Cancer

Shengjing Hospital1 site in 1 country68 target enrollmentStarted: October 1, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
68
Locations
1
Primary Endpoint
inflammation at end of operation

Study Overview

Brief Summary

Many recent studies have shown that surgical trauma will result in an immunosuppressive state. Combined with the effect of surgical stress, it will often lead to metabolic changes, systemic inflammatory response, and other problems. The body resists and removes the harmful factors through the inflammatory reaction. However, an excessive reaction will damage the normal tissues and cells of the body. The smooth recovery of the body needs to balance the degree of inflammatory reaction. Surgical patients will trigger different degrees of an inflammatory response due to different degrees of physical trauma, which runs through the process of postoperative recovery from the beginning of surgery and often prolongs the time of postoperative recovery. Reducing the intraoperative and postoperative inflammatory response of patients has always been the goal of surgeons, and a method is the reduction of surgical trauma.

The successful experience of the first single-port thoracoscopic wedge resection of the lung in 2004 provided us with a new surgical idea. Subsequently, a large number of domestic and international studies and case reports show that single-port thoracoscopic surgery is safe and feasible in lobectomy and segmental resection. With the rapid development of single-port thoracoscopic surgery in recent years, the scope of application and clinical efficacy of the surgery are gradually becoming equivalent to the traditional three-port thoracoscopic surgery, which can ensure the safety of the operation and complete tumor resection, and has its own characteristics and advantages compared with the traditional three-port thoracoscopic surgery. The reduction of incisions can significantly improve the postoperative pain and recovery of patients and wound healing.

In addition, single-port thoracoscopic surgery also has a subtle improvement in patients' intraoperative and postoperative inflammatory response compared with traditional three-port thoracoscopic surgery. In this study, we compared and analyzed the intraoperative and postoperative inflammatory factor levels of single-port thoracoscopic surgery and three-port thoracoscopic surgery in patients with non-small cell lung cancer (NSCLC). Through the comparison of the measured values, we further discussed the advantages of single-port thoracoscopic surgery in reducing inflammatory response and its application and promotion value in the treatment of patients with NSCLC compared with traditional three-port thoracoscopic surgery.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •(1) NSCLC was diagnosed by imaging examination (chest enhanced computed tomography or positron emission tomography-computed tomography) and biopsy pathology; (2) TNM stage was stage I and II; (3) the patient had indications of radical operation; (4) the patient had good cardiopulmonary, liver, and kidney function and no obvious surgical contraindication before operation; (5) the preoperative inflammatory indexes of all patients were within the normal range

Exclusion Criteria

  • •(1) the thoracoscopic operation was converted to thoractomy; (2) the operation time was more than 3 hours; (3) blood vessel rupture occurred during the operation, and the bleeding amount was more than 200 mL; (4) the patient had complications (the patient had fever exceeding 38.5 ℃, chest computed tomography confirmed intrapulmonary infection, incision infection, postoperative bleeding, requiring secondary thoracotomy, etc.).

Arms & Interventions

uni-portal VATS group

Experimental

Intervention: uni-portal VATS group (Other)

three port VATS group

Experimental

Intervention: three port VATS group (Other)

Outcomes

Primary Outcomes

inflammation at end of operation

Time Frame: end of operation

record c-reactive protein after surgery

preoperative inflammation

Time Frame: two days before operation

record c-reactive protein after surgery

chest drainage time

Time Frame: before remove drainage tube

record chest drainage time until remove drainage tube

out-of-bed activity time (Day) and length of hospital stay (Day)

Time Frame: Before discharge from hospital

record the days of patients' out-of-bed activity time and length of hospital stay after surgery

postoperative adverse effects

Time Frame: 24 hours after surgery

record postoperative adverse effects 24 hours after surgery

postoperative inflammation

Time Frame: Day 7 after operation

record IL-6 after surgery

duration of the healing of incision

Time Frame: before suture removal

record the duration of the healing of incision

intraoperative hemorrhage volume

Time Frame: at the end of the surgery

record intraoperative hemorrhage volume at the end of the surgery

postoperative pain

Time Frame: 24 hours after surgery

record postoperative pain 24 hours after surgery by using visual analog scale (VAS) score, where 0 indicates painlessness, and 10 indicates severe pain

postoperative inflammation

Time Frame: 30mins after operation

record c-reactive protein after surgery

postoperative inflammation

Time Frame: Day 1 after operation

record c-reactive protein after surgery

postoperative inflammation

Time Frame: Day 3 after operation

record c-reactive protein after surgery

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yanchao Yang

principal investigator

Shengjing Hospital

Study Sites (1)

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