Reinforced and Non-Reinforced Staple Lines in Fissureless Lobectomy

Trial Title: Reinforced and Non-Reinforced Staple Lines in Fissureless Lobectomy

NCT ID: NCT06602661

Condition: Lung
Lung Adenocarcinoma
Lung Adenosquamous Carcinoma
Lung Cancer, Non-Small Cell
Lung Carcinoma
Lobectomy
Lobectomy Patient
Lobectomy by Video-thoracoscopies
VATS

Conditions: Official terms:
Carcinoma
Lung Neoplasms
Adenocarcinoma of Lung
Carcinoma, Adenosquamous
Carcinoma, Non-Small-Cell Lung

Conditions: Keywords:
Prospective Randomized Study
Fissureless Lobectomy
Prolonged Air Leak (PAL)
Pulmonary Resections
Hospital Length of Stay (LOS)
Lung Carcinoma
Echelon 3000 stapler
Endopath Stapler Line Reinforcement
Video-Assisted Thoracoscopic Surgery (VATS)
Postoperative Outcomes
Intraoperative Characteristics
Randomized Control Trial (RCT)
Surrey Memorial Hospital (SMH)
Surrey Thoracic Surgery Group (STSG)
Digital Drainage System (Thopaz)
Chest Tube Duration
Hospital Readmission
Patient Outcomes
Bioabsorbable Buttress Material
Polyglactin and Polydioxanone

Study type: Interventional

Study phase: Phase 1

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Fissureless Lobectomy with Reinforced Staple Lines
Description: This intervention involves performing a fissureless lobectomy, a type of lung surgery where the lobes of the lung are removed without dissecting the fissures between them. The procedure utilizes the ECHELON™ 3000 stapler equipped with the ENDOPATH™ stapler line reinforcement. The ENDOPATH™ device uses bioabsorbable buttress material made from Polyglactin and Polydioxanone, designed to enhance the durability and effectiveness of the staple line. The reinforcement tool is a novel preloaded device with a "click and go" mechanism, making it easy to load and use during surgery. The primary objective is to reduce the average duration of hospital length of stay (LOS) directly caused by prolonged air leak (PAL). Secondary objectives include improving intraoperative characteristics (such as duration and amount of blood loss) and postoperative outcomes (such as incidence and duration of PALs, number of chest tube days, and incidence of hospital.
Arm group label: Fissureless Lobectomy with Reinforced Staple Lines Using ECHELON™ 3000 and ENDOPATH™ Reinforcement

Intervention type: Procedure
Intervention name: Fissureless Lobectomy with Non-Reinforced Staple Lines
Description: This intervention involves performing a fissureless lobectomy, a type of lung surgery where the lobes of the lung are removed without dissecting the fissures between them. The procedure utilizes the ECHELON™ 3000 stapler without any additional reinforcement. This means the staple lines are created using the standard stapler without the use of bioabsorbable buttress materials. The ECHELON™ 3000 stapler is used to divide the lung parenchyma, pulmonary artery branches, veins, and bronchus without any reinforcement, relying solely on the standard stapling mechanism.
Arm group label: Fissureless Lobectomy with Non-Reinforced Staple Lines Using ECHELON™ 3000

Summary: 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.

Detailed description: The standard definition of a PAL by the Society of Thoracic Surgeons (STS) dictates that the leak persists beyond five days; however, clinical practices commonly broaden this definition to include any instances in which the leak delays hospital discharge. Some studies find that air leaks persisting after 72 hours are indicative of PAL. Therefore, investigators have elected to use 72 hours as our benchmark for this study. In addition to an increased hospital LOS, PAL can heighten costs, increase the incidence of readmission, and induce other postoperative complications. PAL is therefore one of the most significant complications for patients undergoing pulmonary resections, particularly lobectomy for lung cancer. PAL remains a problem despite enhancements in endoscopic surgical techniques; consequently, reinforced staplers have been developed to provide additional support to the staple line, thereby enhancing its sealing capabilities. Reinforced staplers have been used in pulmonary surgeries, including lobectomies, and the results have shown a reduction in PAL occurrence. For example, staplers with polyglycolic acid (PGA) sheets demonstrated a lower postoperative air leakage rate and a reduction in number of chest tube days. Another study reported application of expanded polytetrafluoroethylene (ePTFE) sleeves in the management of air leaks following thoracoscopic and open lung volume reduction surgery. The comparative effectiveness of reinforced versus non-reinforced staplers in the context of fissureless lobectomy has not yet been established. By implementing a randomized control trial design, this prospective study will attempt to fill this knowledge gap and uncover the ability of reinforced staplers to improve patient outcomes. To quantify these effects, hospital LOS will be used as a primary measure. Additional intraoperative and postoperative characteristics will be used to document any secondary benefits to reinforced staplers regarding their safety and effectiveness.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Patients aged 18 and over. - Patients undergoing fissureless lobectomy for lung carcinoma. Exclusion Criteria: - Patients suitable for sub lobar resections. - Patients undergoing lobectomy for indications other than lung cancer. - Patients with a history of pleural adhesions. - Patients with previous lung resection on the same side.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Surrey Thoracic Surgery Group

Address:
City: Surrey
Zip: V3V 0C6
Country: Canada

Contact:
Last name: Tayne M Registered Nurse

Phone: 778 735 0230
Email: tayne.bong@fraserhealth.ca

Start date: January 1, 2025

Completion date: January 2028

Lead sponsor:
Agency: Surrey Thoracic Surgery Group
Agency class: Other

Collaborator:
Agency: Johnson and Johnson Medical
Agency class: Other

Source: Surrey Thoracic Surgery Group

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06602661
https://academic.oup.com/ejcts/article/39/4/584/525799
https://ebook.sts.org/sts/view/Pearsons-General-Thoracic/1418125/all/Early_Postoperative_Complications
https://pubmed.ncbi.nlm.nih.gov/38870914/
https://pubmed.ncbi.nlm.nih.gov/15691691/
https://pubmed.ncbi.nlm.nih.gov/32099487/