Clinical trial · Interventional
Reinforced and Non-Reinforced Staple Lines in Fissureless Lobectomy
A Prospective Randomized Study of Reinforced Vs Non-reinforced Staple Lines in Fissureless Lobectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lobectomy | — | UNRESOLVED | — |
| Lobectomy by Video-thoracoscopies | — | UNRESOLVED | — |
| Lobectomy Patient | — | UNRESOLVED | — |
| Lung | — | UNRESOLVED | — |
| Lung Adenocarcinoma | Lung Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Lung Adenosquamous Carcinoma | Lung Adenosquamous Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Lung Cancer, Non-Small Cell | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Lung Carcinoma | Lung Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fissureless Lobectomy with Non-Reinforced Staple Lines | Procedure | — | UNRESOLVED |
| Fissureless Lobectomy with Reinforced Staple Lines | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Fissureless Lobectomy with Non-Reinforced Staple Lines Using ECHELON™ 3000
- description
- 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.
- interventionNames
- Procedure: Fissureless Lobectomy with Non-Reinforced Staple Lines
- type
- EXPERIMENTAL
- label
- Fissureless Lobectomy with Reinforced Staple Lines Using ECHELON™ 3000 and ENDOPATH™ Reinforcement
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available