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Procedure

Reinforced vs Non-Reinforced Staple Lines for Lung Cancer

Phase 1

Waitlist Available

Research Sponsored by Surrey Thoracic Surgery Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients undergoing fissureless lobectomy for lung carcinoma

Patients aged 18 and over

Must not have

Patients undergoing lobectomy for indications other than lung cancer

Patients with previous lung resection on the same side

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 30 days post-surgery

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to determine if reinforced staplers are more effective at reducing prolonged air leaks and complications after lung surgery compared to standard staplers. Reinforced staplers, which have special materials like polygly

Who is the study for?

This trial is for patients with certain types of lung cancer who are undergoing a specific surgical procedure called fissureless lobectomy. Ideal candidates should not have any conditions that would exclude them from the study, which are not specified in the provided information.

What is being tested?

The study compares two methods of closing tissue during lung surgery: one uses staples reinforced with special materials to prevent air leaks, and the other uses standard non-reinforced staples. The goal is to see if reinforced staplers lead to better outcomes.

What are the potential side effects?

While specific side effects are not detailed, potential risks may include complications related to staple lines such as prolonged air leaks, infection at the surgery site, or issues related to chest tubes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am having a specific lung surgery without cutting the lung fissure.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am having a lobectomy for reasons other than lung cancer.

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I have had part of my lung removed on one side before.

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I have had pleural adhesions in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days post- surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days post- surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days post- surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Intraoperative Characteristics and Postoperative Outcomes

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Fissureless Lobectomy with Reinforced Staple Lines Using ECHELON™ 3000 and ENDOPATH™ ReinforcementExperimental Treatment1 Intervention

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 II: Fissureless Lobectomy with Non-Reinforced Staple Lines Using ECHELON™ 3000Active Control1 Intervention

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.

0 / 5Eligibility criteria met