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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether reinforced staplers can reduce air leaks more effectively than regular staplers in lung cancer surgery. Air leaks commonly occur after lung surgery and can lead to longer hospital stays and complications. The trial compares two groups: one using standard staplers and the other using reinforced staplers, both during a type of surgery called fissureless lobectomy. Ideal participants are adults undergoing this surgery specifically for lung cancer. The study aims to determine which stapler method better prevents air leaks. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

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 prior data suggests that reinforced staplers are safe for use in lung surgeries?

Previous studies have safely used special staplers in lung surgeries. These staplers often contain materials like polyglycolic acid (PGA) or expanded polytetrafluoroethylene (ePTFE) to strengthen the staple line. Research shows they help reduce air leaks and shorten the time patients need chest tubes, potentially leading to a shorter hospital stay.

While these reinforced staplers have generally been safe, their safety in a specific type of lung surgery called fissureless lobectomy (which avoids cutting into lung tissue) remains unconfirmed. As this is a Phase 1 study, the main goal is to ensure safety, with any potential risks closely monitored. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these fissureless lobectomy techniques for lung cancer because they could potentially minimize complications after surgery. Unlike traditional lobectomy methods that may involve reinforced staples only in certain situations, this approach specifically tests the impact of using reinforced versus non-reinforced staple lines. The reinforced staple line, which includes ENDOPATH™ reinforcement, aims to provide extra support to the lung tissue, potentially reducing air leaks and improving recovery times. This comparison could lead to a more standardized use of reinforcement techniques, enhancing patient outcomes and streamlining surgical practices.

What evidence suggests that reinforced staplers are effective for reducing prolonged air leaks in lung cancer surgery?

This trial will compare reinforced versus non-reinforced staple lines in fissureless lobectomy for lung cancer. Research suggests that reinforced staplers might reduce long-lasting air leaks after lung surgery. Studies have found that materials like polyglycolic acid (PGA) sheets in these staplers can decrease air leakage and reduce the number of days chest tubes are needed. Another material, expanded polytetrafluoroethylene (ePTFE) sleeves, has also effectively controlled air leaks in various lung surgeries. Although these benefits have been observed in different lung surgeries, they haven't been specifically studied in fissureless lobectomy. The general idea is that reinforced staplers strengthen the staple line, potentially reducing complications. Participants in this trial will be assigned to either the reinforced or non-reinforced staple line group to evaluate these potential benefits. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06602661

Reinforced and Non-Reinforced Staple Lines in Fissureless ... The ECHELON™ 3000 stapler is used to divide the lung parenchyma, pulmonary artery branches, veins, and bronchus without any reinforcement, relying solely on the ...

2. ctv.veeva.com ctv.veeva.com/study/reinforced-and-non-reinforced-staple-lines-in-fissureless-lobectomy

Reinforced and Non-Reinforced Staple Lines in Fissureless ... The comparative effectiveness of reinforced versus non-reinforced staplers in the context of fissureless lobectomy has not yet been established.

3. withpower.com withpower.com/trial/phase-1-lung-adenosquamous-carcinoma-2025-519f3

Reinforced vs Non-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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11189967/

Safety and efficacy of new staple-line reinforcement in lung ... The use of SLR in pulmonary resection was safe and effective. When compared with conventional products, SLR could control intraoperative air leakage from the ...

5. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/534516

Reinforced and Non-Reinforced Staple Lines in ... This intervention involves performing a fissureless lobectomy, a type of lung surgery where the lobes of the lung are removed without dissecting the fissures ...