Reinforced and Non-Reinforced Staple Lines in Fissureless Lobectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2028-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fissureless Lobectomy with Non-Reinforced Staple Lines Using ECHELON™ 3000

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.

Group Type ACTIVE_COMPARATOR

Fissureless Lobectomy with Non-Reinforced Staple Lines

Intervention Type PROCEDURE

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.

Fissureless Lobectomy with Reinforced Staple Lines Using ECHELON™ 3000 and ENDOPATH™ Reinforcement

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 Type EXPERIMENTAL

Fissureless Lobectomy with Reinforced Staple Lines

Intervention Type PROCEDURE

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.

Interventions

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Fissureless 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.

Intervention Type PROCEDURE

Fissureless 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No