Reinforced and Non-Reinforced Staple Lines in Fissureless Lobectomy

NCT06602661 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: 6997
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Change in Hospital Length of Stay Due to Prolonged Air Leak (PAL)

  1\. 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

  Up to 30 days post- surgery

Secondary Outcomes (1)

• Intraoperative Characteristics and Postoperative Outcomes

  Within 30 days post-surgery

Study Arms (2)

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

ACTIVE COMPARATOR

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.

Procedure: Fissureless Lobectomy with Non-Reinforced Staple Lines

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

EXPERIMENTAL

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.

Procedure: Fissureless Lobectomy with Reinforced Staple Lines

Interventions

Fissureless Lobectomy with Reinforced Staple Lines 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.

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 and over.
• Patients undergoing fissureless lobectomy for lung carcinoma.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Surrey Thoracic Surgery Group: lead
• Johnson and Johnson Medical: collaborator

Study Sites (1)

Surrey Thoracic Surgery Group

Surrey, B.C, V3V 0C6, Canada

Location

Related Links

• Early Postoperative Complications
• Endobronchial Valves in Treatment of Persistent Air Leak
• Estimating hospital costs attributable to prolonged air leak in pulmonary lobectomy
• A Novel, Easy-to-Use Staple Line Reinforcement for Surgical Staplers

MeSH Terms

Conditions

Adenocarcinoma of Lung; Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 19, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The IPD and supporting information will be available starting from January 1, 2028.
• Access Criteria: * Qualified researchers affiliated with academic, medical, or research institutions. * Healthcare professionals involved in related clinical research or patient care. * Regulatory authorities for the purpose of regulatory review and compliance. They Will Be Able to Access: * De-identified Individual Participant Data (IPD), including demographic information, clinical outcomes, and other relevant variables. * Supporting information such as study protocols, statistical analysis plans, and informed consent forms. How They Will Be Able to Access It: * Interested parties must submit a formal request to the Principal Investigator (PI) at Dr. Ahmad S. Ashrafi. * Upon approval, a data use agreement (DUA) must be signed. * Approved researchers will access the data through a secure, password-protected online platform.

Locations

CA (1)