LungPhase 1NCT06602661
Reinforced and Non-Reinforced Staple Lines in Fissureless Lobectomy
A Phase 1 study testing Fissureless Lobectomy with Reinforced Staple Lines and Fissureless Lobectomy with Non-Reinforced Staple Lines in people with Lung and Lung Adenocarcinoma, run by Surrey Thoracic Surgery Group at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung, Lung Adenocarcinoma, Lung Adenosquamous Carcinoma
- What is being tested?
- Fissureless Lobectomy with Reinforced Staple Lines and Fissureless Lobectomy with Non-Reinforced Staple Lines
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2025to Jan 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 and over.
- Patients undergoing fissureless lobectomy for lung carcinoma.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Surrey Thoracic Surgery Group
Surrey, B.C, V3V 0C6
Tayne M Registered Nurse, 778 735 0230, tayne.bong@fraserhealth.ca
About this study
Official title: A Prospective Randomized Study of Reinforced Vs Non-reinforced Staple Lines in Fissureless Lobectomy
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.
Read the 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.
- Conditions
- Lung, Lung Adenocarcinoma, Lung Adenosquamous Carcinoma, Lung Cancer, Non-Small Cell, Lung Carcinoma, Lobectomy
- Being tested
- Fissureless Lobectomy with Reinforced Staple Lines, Fissureless Lobectomy with Non-Reinforced Staple Lines
- 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
- Medical subject headings
- Adenocarcinoma of Lung, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fissureless Lobectomy with Reinforced Staple LinesProcedure or surgery
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 Non-Reinforced Staple LinesProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Fissureless Lobectomy with Reinforced Staple Lines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hospital Length of Stay Due to Prolonged Air Leak (PAL)
- 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
Measured: Up to 30 days post- surgery
Secondary outcomes (1)
Intraoperative Characteristics and Postoperative Outcomes
- 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
Measured: Within 30 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jan 2025 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Surrey Thoracic Surgery Group
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson K.K. Medical Company
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06602661
- Sponsor's protocol ID
- 6997
- Status last verified
- Sep 2024
- First submitted
- 13 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD: This encompasses all data gathered during the study, including preoperative, intraoperative, and postoperative variables. IPD that underlie results in a publication: This includes data that directly support the findings and conclusions presented in any resulting publications from the study.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study of Reinforced Vs Non-reinforced Staple Lines in Fissureless Lobectomy
- ClinicalTrials.gov ID
- NCT06602661
- Acronym / sponsor ID
- 6997
- Conditions
- Lung, Lung Adenocarcinoma, Lung Adenosquamous Carcinoma, Lung Cancer, Non-Small Cell, Lung Carcinoma, Lobectomy
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Surrey Thoracic Surgery GroupUniversity, hospital or other
- Collaborators
- Johnson & Johnson K.K. Medical Company
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fissureless Lobectomy with Non-Reinforced Staple Lines Using ECHELON™ 3000 | Active comparator | Procedure: Fissureless Lobectomy with Non-Reinforced Staple LinesArm 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. |
| Fissureless Lobectomy with Reinforced Staple Lines Using ECHELON™ 3000 and ENDOPATH™ Reinforcement | Experimental | Procedure: Fissureless Lobectomy with Reinforced Staple LinesParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18 and over.
- Patients undergoing fissureless lobectomy for lung carcinoma.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fissureless Lobectomy with Reinforced Staple LinesThis 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. | Procedure or surgery | Fissureless Lobectomy with Reinforced Staple Lines Using ECHELON™ 3000 and ENDOPATH™ Reinforcement |
| Fissureless Lobectomy with Non-Reinforced Staple LinesThis 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. | Procedure or surgery | Fissureless Lobectomy with Non-Reinforced Staple Lines Using ECHELON™ 3000 |
Primary outcome
Change in Hospital Length of Stay Due to Prolonged Air Leak (PAL)
Time frame: Up to 30 days post- surgery
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
1 secondary outcome
Intraoperative Characteristics and Postoperative Outcomes
Time frame: Within 30 days post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Early Postoperative ComplicationsLink provided by the sponsor.
- Endobronchial Valves in Treatment of Persistent Air LeakLink provided by the sponsor.
- Estimating hospital costs attributable to prolonged air leak in pulmonary lobectomyLink provided by the sponsor.
- A Novel, Easy-to-Use Staple Line Reinforcement for Surgical StaplersLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All collected IPD: This encompasses all data gathered during the study, including preoperative, intraoperative, and postoperative variables. IPD that underlie results in a publication: This includes data that directly support the findings and conclusions presented in any resulting publications from the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fissureless Lobectomy with Reinforced Staple Lines and Fissureless Lobectomy with Non-Reinforced Staple Lines in people with Lung and Lung Adenocarcinoma, run by Surrey Thoracic Surgery Group at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hospital Length of Stay Due to Prolonged Air Leak (PAL) (time frame: Up to 30 days post- surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.