Clinical trial NCT06602661: Reinforced and Non-Reinforced Staple Lines in Fissureless Lobectomy
Official title: A Prospective Randomized Study of Reinforced Vs Non-reinforced Staple Lines in Fissureless Lobectomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Lung
Lung Adenocarcinoma
Lung Adenosquamous Carcinoma
Lung Cancer, Non-Small Cell
Lung Carcinoma
Lobectomy
Lobectomy Patient
Lobectomy by Video-thoracoscopies
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
Lead sponsor: Surrey Thoracic Surgery Group
Sponsor class: OTHER
Collaborators: name: Johnson and Johnson Medical
First posted: 2024-09-19
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Hospital Length of Stay Due to Prolonged Air Leak (PAL)
timeFrame: Up to 30 days post- surgery
Secondary outcomes:
measure: Intraoperative Characteristics and Postoperative Outcomes
timeFrame: Within 30 days post-surgery
Other outcomes:
Locations:
city: Surrey
country: Canada
facility: Surrey Thoracic Surgery Group
state: B.C
Study officials:
References: