Video-assisted Thoracoscopic SurgeryNCT05070026
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
A study testing uni-portal VATS group and three port VATS group in people with Video-assisted Thoracoscopic Surgery and Inflammatory Reaction, run by Shengjing Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Video-assisted Thoracoscopic Surgery, Inflammatory Reaction, Life Scores
- What is being tested?
- uni-portal VATS group and three port VATS group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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
Who cannot join
- (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.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- uni-portal VATS group, three port VATS group
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uni-portal VATS groupOther
patients received pulmonary lobectomy under general anesthesia by using uni-portal VATS method
three port VATS groupOther
patients received pulmonary lobectomy under under general anesthesia by using three port VATS method
| Study group | Role | What they receive |
|---|---|---|
| uni-portal VATS group | Experimental | Not described Receives: Other: uni-portal VATS group |
| three port VATS group | Experimental | Not described Receives: Other: three port VATS group |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative hemorrhage volume
record intraoperative hemorrhage volume at the end of the surgery
Measured: at the end of the surgery
chest drainage time
record chest drainage time until remove drainage tube
Measured: before remove drainage tube
duration of the healing of incision
record the duration of the healing of incision
Measured: 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
Measured: 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
Measured: 24 hours after surgery
postoperative adverse effects
record postoperative adverse effects 24 hours after surgery
Measured: 24 hours after surgery
preoperative inflammation
record c-reactive protein after surgery
Measured: two days before operation
inflammation at end of operation
record c-reactive protein after surgery
Measured: end of operation
postoperative inflammation
record c-reactive protein after surgery
Measured: 30mins after operation
postoperative inflammation
record c-reactive protein after surgery
Measured: Day 1 after operation
postoperative inflammation
record c-reactive protein after surgery
Measured: Day 3 after operation
preoperative inflammation
record serum amyloid A protein (SAA) after surgery
Measured: two days before operation
inflammation at end of operation
record serum amyloid A protein (SAA) after surgery
Measured: end of operation
postoperative inflammation
record serum amyloid A protein (SAA) after surgery
Measured: 30mins after operation
postoperative inflammation
record serum amyloid A protein (SAA) after surgery
Measured: Day 1 after operation
postoperative inflammation
record serum amyloid A protein (SAA) after surgery
Measured: Day 3 after operation
preoperative inflammation
record IL-6 after surgery
Measured: two days before operation
inflammation at end of operation
record IL-6 after surgery
Measured: end of operation
postoperative inflammation
record IL-6 after surgery
Measured: 30mins after operation
postoperative inflammation
record IL-6 after surgery
Measured: Day 1 after operation
postoperative inflammation
record IL-6 after surgery
Measured: Day 7 after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start1 Oct 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Video-assisted Thoracoscopic SurgeryStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanchao Yang, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05070026
- Sponsor's protocol ID
- uni-portal and three port VATS
- Status last verified
- Aug 2022
- First submitted
- 12 Sep 2021
- Last updated
- 16 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Inflammatory Cytokine Levels Between Single-port and Three-port Thoracoscopic Lobectomy in the Treatment of Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05070026
- Acronym / sponsor ID
- uni-portal and three port VATS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 6 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| uni-portal VATS group | Experimental | Other: uni-portal VATS group |
| three port VATS group | Experimental | Other: three port VATS group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (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
Key exclusion criteria (1 listed)
- (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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| uni-portal VATS grouppatients received pulmonary lobectomy under general anesthesia by using uni-portal VATS method | Other | uni-portal VATS group |
| three port VATS grouppatients received pulmonary lobectomy under under general anesthesia by using three port VATS method | Other | three port VATS group |
Primary outcome
intraoperative hemorrhage volume
Time frame: at the end of the surgery
record intraoperative hemorrhage volume at the end of the surgery
chest drainage time
Time frame: before remove drainage tube
record chest drainage time until remove drainage tube
duration of the healing of incision
Time frame: before suture removal
record the duration of the healing of incision
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 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 adverse effects
Time frame: 24 hours after surgery
record postoperative adverse effects 24 hours after surgery
preoperative inflammation
Time frame: two days before operation
record c-reactive protein after surgery
inflammation at end of operation
Time frame: end of operation
record c-reactive protein after surgery
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
preoperative inflammation
Time frame: two days before operation
record serum amyloid A protein (SAA) after surgery
inflammation at end of operation
Time frame: end of operation
record serum amyloid A protein (SAA) after surgery
postoperative inflammation
Time frame: 30mins after operation
record serum amyloid A protein (SAA) after surgery
postoperative inflammation
Time frame: Day 1 after operation
record serum amyloid A protein (SAA) after surgery
postoperative inflammation
Time frame: Day 3 after operation
record serum amyloid A protein (SAA) after surgery
preoperative inflammation
Time frame: two days before operation
record IL-6 after surgery
inflammation at end of operation
Time frame: end of operation
record IL-6 after surgery
postoperative inflammation
Time frame: 30mins after operation
record IL-6 after surgery
postoperative inflammation
Time frame: Day 1 after operation
record IL-6 after surgery
postoperative inflammation
Time frame: Day 7 after operation
record IL-6 after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing uni-portal VATS group and three port VATS group in people with Video-assisted Thoracoscopic Surgery and Inflammatory Reaction, run by Shengjing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraoperative hemorrhage volume (time frame: at the end of the surgery). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2022.