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

Video-assisted Thoracoscopic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05070026
• Other study ID #: uni-portal and three port VATS
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2022
• Source: Shengjing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.).

Related Conditions & MeSH terms

• Inflammation
• Inflammatory Reaction
• Video-assisted Thoracoscopic Surgery

Intervention

Other:
• uni-portal VATS group
patients received pulmonary lobectomy under general anesthesia by using uni-portal VATS method
• three port VATS group
patients received pulmonary lobectomy under under general anesthesia by using three port VATS method

Locations

Country	Name	City	State
China	Shengjing Hospital	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shengjing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intraoperative hemorrhage volume	record intraoperative hemorrhage volume at the end of the surgery	at the end of the surgery
Primary	chest drainage time	record chest drainage time until remove drainage tube	before remove drainage tube
Primary	duration of the healing of incision	record the duration of the healing of incision	before suture removal
Primary	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
Primary	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
Primary	postoperative adverse effects	record postoperative adverse effects 24 hours after surgery	24 hours after surgery
Primary	preoperative inflammation	record c-reactive protein after surgery	two days before operation
Primary	inflammation at end of operation	record c-reactive protein after surgery	end of operation
Primary	postoperative inflammation	record c-reactive protein after surgery	30mins after operation
Primary	postoperative inflammation	record c-reactive protein after surgery	Day 1 after operation
Primary	postoperative inflammation	record c-reactive protein after surgery	Day 3 after operation
Primary	preoperative inflammation	record serum amyloid A protein (SAA) after surgery	two days before operation
Primary	inflammation at end of operation	record serum amyloid A protein (SAA) after surgery	end of operation
Primary	postoperative inflammation	record serum amyloid A protein (SAA) after surgery	30mins after operation
Primary	postoperative inflammation	record serum amyloid A protein (SAA) after surgery	Day 1 after operation
Primary	postoperative inflammation	record serum amyloid A protein (SAA) after surgery	Day 3 after operation
Primary	preoperative inflammation	record IL-6 after surgery	two days before operation
Primary	inflammation at end of operation	record IL-6 after surgery	end of operation
Primary	postoperative inflammation	record IL-6 after surgery	30mins after operation
Primary	postoperative inflammation	record IL-6 after surgery	Day 1 after operation
Primary	postoperative inflammation	record IL-6 after surgery	Day 7 after operation