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

Sponsor
Shengjing Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05070026
Collaborator
(none)
68
1
2
3
22.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: uni-portal VATS group
  • Other: three port VATS group
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
68 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of Inflammatory Cytokine Levels Between Single-port and Three-port Thoracoscopic Lobectomy in the Treatment of Non-small Cell Lung Cancer
Actual Study Start Date :
Oct 1, 2021
Actual Primary Completion Date :
Dec 31, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. intraoperative hemorrhage volume [at the end of the surgery]

    record intraoperative hemorrhage volume at the end of the surgery

  2. chest drainage time [before remove drainage tube]

    record chest drainage time until remove drainage tube

  3. duration of the healing of incision [before suture removal]

    record the duration of the healing of incision

  4. out-of-bed activity time (Day) and length of hospital stay (Day) [Before discharge from hospital]

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

  5. postoperative pain [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

  6. postoperative adverse effects [24 hours after surgery]

    record postoperative adverse effects 24 hours after surgery

  7. preoperative inflammation [two days before operation]

    record c-reactive protein after surgery

  8. inflammation at end of operation [end of operation]

    record c-reactive protein after surgery

  9. postoperative inflammation [30mins after operation]

    record c-reactive protein after surgery

  10. postoperative inflammation [Day 1 after operation]

    record c-reactive protein after surgery

  11. postoperative inflammation [Day 3 after operation]

    record c-reactive protein after surgery

  12. preoperative inflammation [two days before operation]

    record serum amyloid A protein (SAA) after surgery

  13. inflammation at end of operation [end of operation]

    record serum amyloid A protein (SAA) after surgery

  14. postoperative inflammation [30mins after operation]

    record serum amyloid A protein (SAA) after surgery

  15. postoperative inflammation [Day 1 after operation]

    record serum amyloid A protein (SAA) after surgery

  16. postoperative inflammation [Day 3 after operation]

    record serum amyloid A protein (SAA) after surgery

  17. preoperative inflammation [two days before operation]

    record IL-6 after surgery

  18. inflammation at end of operation [end of operation]

    record IL-6 after surgery

  19. postoperative inflammation [30mins after operation]

    record IL-6 after surgery

  20. postoperative inflammation [Day 1 after operation]

    record IL-6 after surgery

  21. postoperative inflammation [Day 7 after operation]

    record IL-6 after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
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.).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shengjing Hospital Shenyang Liaoning China 110004

Sponsors and Collaborators

  • Shengjing Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yanchao Yang, principal investigator, Shengjing Hospital
ClinicalTrials.gov Identifier:
NCT05070026
Other Study ID Numbers:
  • uni-portal and three port VATS
First Posted:
Oct 6, 2021
Last Update Posted:
Aug 16, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 16, 2022