Reinforced vs Non-Reinforced Staple Lines for Lung Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Surrey Thoracic Surgery Group

Disqualifiers: Sub lobar resections, Pleural adhesions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 week

65 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Fissureless Lobectomy with Reinforced Staple Lines for lung cancer?

Research shows that the fissureless technique, which avoids cutting into the lung tissue, can significantly reduce the risk of prolonged air leaks after lung surgery. Additionally, using reinforcement materials with staples has been shown to help reduce air leaks, making the procedure safer and more effective. ^{1 2 3 4 5}

Is the use of reinforced and non-reinforced staple lines in lung surgery safe?

Reinforced staple lines in lung surgery may reduce leaks and bleeding, potentially lowering complications, but their safety is still debated. Staplers are generally considered safe, though severe adverse events, like bleeding, can occur and should be monitored. ^{6 7 8 9 10}

How does the fissureless lobectomy with reinforced staple lines treatment differ from other treatments for lung cancer?

The fissureless lobectomy with reinforced staple lines is unique because it uses special materials to strengthen the staple lines during lung surgery, which helps reduce air leaks and speeds up recovery compared to traditional methods. This approach is particularly beneficial in preventing prolonged air leaks, a common complication after lung surgery. ^{1 2 3 5 11}

What is the purpose of this trial?

Prolonged Air Leak (PAL) is a common and serious problem after lung surgery. It can lead to worse patient outcomes, longer hospital stays, and higher costs. Reinforced staplers are designed to make the staple line stronger and reduce the risk of PAL. However, investigators don't know if they are better than standard staplers, especially in a specific type of lung surgery called fissureless lobectomy for lung cancer. This study aims to find out if reinforced staplers are more effective at reducing PAL and its complications compared to non-reinforced staplers. Reinforced staplers have been used in lung surgeries and have shown to reduce PAL. For example, staplers with special materials like polyglycolic acid (PGA) sheets have shown lower air leakage and fewer days with chest tubes. Other materials like expanded polytetrafluoroethylene (ePTFE) sleeves have also been used to manage air leaks in different types of lung surgeries. However, their effectiveness in fissureless lobectomy has not been studied yet.

Eligibility Criteria

This trial is for patients with certain types of lung cancer who are undergoing a specific surgical procedure called fissureless lobectomy. Ideal candidates should not have any conditions that would exclude them from the study, which are not specified in the provided information.

Inclusion Criteria

I am having a specific lung surgery without cutting the lung fissure.

Exclusion Criteria

I am having a lobectomy for reasons other than lung cancer.

I have had part of my lung removed on one side before.

I am a candidate for a minor lung surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo fissureless lobectomy using either reinforced or non-reinforced staplers

1 week

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for air leaks and other postoperative outcomes, including daily chest X-rays and drainage assessments

Up to 30 days

Daily monitoring (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including readmission rates and prolonged air leak duration

30 days

Treatment Details

Interventions

• Fissureless Lobectomy with Non-Reinforced Staple Lines
• Fissureless Lobectomy with Reinforced Staple Lines

Trial Overview The study compares two methods of closing tissue during lung surgery: one uses staples reinforced with special materials to prevent air leaks, and the other uses standard non-reinforced staples. The goal is to see if reinforced staplers lead to better outcomes.

Participant Groups

Group I: Fissureless Lobectomy with Reinforced Staple Lines Using ECHELON™ 3000 and ENDOPATH™ Reinforcement Experimental Treatment 1 Intervention

Participants in the experimental arm will undergo fissureless lobectomy using the ECHELON™ 3000 stapler equipped with the ENDOPATH™ stapler line reinforcement. This intervention involves:Thorough patient assessment and confirmation of eligibility criteria. Informed consent process emphasizing the use of reinforced staplers. Standard general anesthesia with double lumen endotracheal tube and patient positioning for lobectomy. Utilization of video-assisted thoracoscopic surgery (VATS). Division of pulmonary artery branches, veins, and bronchus with non-reinforced stapler. Division of lung parenchyma using the ECHELON™ 3000 stapler with ENDOPATH™ reinforcement. Placement of chest tube size 28 Fr for all patients. Standard postoperative monitoring in the recovery room and monitored bed afterward. Implementation of standardized pain management protocols. Assessment for air leaks and drainage amount using a digital drainage system (Thopaz). Performing daily chest X-rays (CXR) until removal.

Group II: Fissureless Lobectomy with Non-Reinforced Staple Lines Using ECHELON™ 3000 Active Control 1 Intervention

Arm Description: Participants in the control arm will undergo fissureless lobectomy using the ECHELON™ 3000 stapler without any reinforcement. This intervention involves: Thorough patient assessment and confirmation of eligibility criteria. Informed consent process emphasizing the use of non-reinforced staplers. Standard general anesthesia with double lumen endotracheal tube and patient positioning for lobectomy. Utilization of video-assisted thoracoscopic surgery (VATS). Division of pulmonary artery branches, veins, and bronchus with non-reinforced stapler. Division of lung parenchyma using the ECHELON™ 3000 stapler without reinforcement. Placement of chest tube size 28 Fr for all patients. Standard postoperative monitoring in the recovery room and monitored bed afterward. Implementation of standardized pain management protocols. Regular assessment for air leaks and drainage amount using a digital drainage system (Thopaz). Performing daily chest X-rays (CXR) until tube removal.

Who Is Running the Clinical Trial?

Surrey Thoracic Surgery Group

Lead Sponsor

Trials

1

Recruited

70+

Johnson and Johnson Medical

Collaborator

Trials

2

Recruited

110+

References

1. United States pubmed.ncbi.nlm.nih.gov

Lung resection using surgical staples in dogs and cats. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Medical and Economic Evaluation of FOREseal Bioabsorbable Reinforcement Sleeves Compared With Current Standard of Care for Reducing Air Leakage Duration After Lung Resection for Malignancy: A Randomized Trial. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Does the fissureless technique decrease the incidence of prolonged air leak after pulmonary lobectomy? [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The Correlation Between Fissureless Technique and Prolonged Air Leak for Patients Undergoing Video-Assisted Right Upper Lobectomy. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Pseudotumor associated with polytetrafluoroethylene sleeves. [2016]

6. China pubmed.ncbi.nlm.nih.gov

Clinical outcomes of pre-attached reinforced stapler reloads in thoracic surgery: a prospective case series. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Delayed severe hemothorax caused by a staple line of a bullectomy performed 11 years earlier. [2023]

8. Japan pubmed.ncbi.nlm.nih.gov

Adverse events of lung tissue stapling in thoracic surgery. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Uniportal thoracoscopic fissureless right lower lobectomy using the suction device trick. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Efficacy of the fissureless technique on decreasing the incidence of prolonged air leak after pulmonary lobectomy: A systematic review and meta-analysis. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Functional comparison of staple line reinforcements in lung resection. [2017]