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Reinforced and Non-Reinforced Staple Lines in Fissureless Lobectomy

A Prospective Randomized Study of Reinforced Vs Non-reinforced Staple Lines in Fissureless Lobectomy

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06602661
Enrollment
65
Registered
2024-09-19
Start date
2025-01-01
Completion date
2028-01-31
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

Brief 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.

Interventions

PROCEDUREFissureless Lobectomy with Reinforced Staple Lines

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.

PROCEDUREFissureless Lobectomy with Non-Reinforced Staple Lines

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.

Sponsors

Johnson and Johnson Medical
CollaboratorUNKNOWN
Surrey Thoracic Surgery Group
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Hospital Length of Stay Due to Prolonged Air Leak (PAL)Up to 30 days post- surgery1\. The primary objective is to determine whether the use of reinforced staple lines in fissureless lobectomies will reduce the average duration of hospital length of stay directly caused by prolonged air leaks. -measured in days

Secondary

MeasureTime frameDescription
Intraoperative Characteristics and Postoperative OutcomesWithin 30 days post-surgery1\. The number or percentage of patients experiencing prolonged air leaks postoperatively. * measured by number or Percentage 2. The duration of prolonged air leaks in days. * Measured in Days 3. The total number of days each patient has a chest tube in place postoperatively. * Measured in Days 4. The number or percentage of patients readmitted to the hospital within 30 days post-surgery. * Measured in number or Percentage

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026