Reinforced vs Non-Reinforced Staple Lines for Lung Cancer

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Surrey Thoracic Surgery Group

No Placebo Group

Trial Summary

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.

Research Team

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.

I am 18 years old or older.

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.

Treatment Details

Interventions

• Fissureless Lobectomy with Non-Reinforced Staple Lines (Procedure)
• Fissureless Lobectomy with Reinforced Staple Lines (Procedure)

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+