Comparison of Inflammatory Cytokine Levels Between Single-port and Three-port Thoracoscopic Lobectomy in the Treatment of Non-small Cell Lung Cancersurgery on Perioperative Clinical Indexes、Inflammatory Reaction and Quality of Life Scores of Patients With Non-small Cell Lung Cancer

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

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 Overview

• Status: Completed
• Conditions: Video-assisted Thoracoscopic Surgery; Inflammatory Reaction; Life Scores
• Intervention / Treatment: Other: uni-portal VATS group; Other: three port VATS group

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Shengjing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: uni-portal VATS group	Other: uni-portal VATS group; patients received pulmonary lobectomy under general anesthesia by using uni-portal VATS method
Experimental: three port VATS group	Other: three port VATS group; patients received pulmonary lobectomy under under general anesthesia by using three port VATS method

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative hemorrhage volume	record intraoperative hemorrhage volume at the end of the surgery	at the end of the surgery
chest drainage time	record chest drainage time until remove drainage tube	before remove drainage tube
duration of the healing of incision	record the duration of the healing of incision	before suture removal
out-of-bed activity time (Day) and length of hospital stay (Day)	record the days of patients' out-of-bed activity time and length of hospital stay after surgery	Before discharge from hospital
postoperative pain	record postoperative pain 24 hours after surgery by using visual analog scale (VAS) score, where 0 indicates painlessness, and 10 indicates severe pain	24 hours after surgery
postoperative adverse effects	record postoperative adverse effects 24 hours after surgery	24 hours after surgery
preoperative inflammation	record c-reactive protein after surgery	two days before operation
inflammation at end of operation	record c-reactive protein after surgery	end of operation
postoperative inflammation	record c-reactive protein after surgery	30mins after operation
postoperative inflammation	record c-reactive protein after surgery	Day 1 after operation
postoperative inflammation	record c-reactive protein after surgery	Day 3 after operation
preoperative inflammation	record serum amyloid A protein (SAA) after surgery	two days before operation
inflammation at end of operation	record serum amyloid A protein (SAA) after surgery	end of operation
postoperative inflammation	record serum amyloid A protein (SAA) after surgery	30mins after operation
postoperative inflammation	record serum amyloid A protein (SAA) after surgery	Day 1 after operation
postoperative inflammation	record serum amyloid A protein (SAA) after surgery	Day 3 after operation
preoperative inflammation	record IL-6 after surgery	two days before operation
inflammation at end of operation	record IL-6 after surgery	end of operation
postoperative inflammation	record IL-6 after surgery	30mins after operation
postoperative inflammation	record IL-6 after surgery	Day 1 after operation
postoperative inflammation	record IL-6 after surgery	Day 7 after operation

Collaborators and Investigators

• Sponsor: Shengjing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: September 12, 2021
• First Submitted That Met QC Criteria: September 27, 2021
• First Posted (Actual): October 6, 2021

Study Record Updates

• Last Update Posted (Actual): August 16, 2022
• Last Update Submitted That Met QC Criteria: August 13, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: uni-portal and three port VATS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No