Reinforced and Non-Reinforced Staple Lines in Fissureless Lobectomy

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

January 1, 2025

Primary Completion Date

January 31, 2028

Study Completion Date

January 31, 2028

Conditions
LungLung AdenocarcinomaLung Adenosquamous CarcinomaLung Cancer, Non-Small CellLung CarcinomaLobectomyLobectomy PatientLobectomy by Video-thoracoscopiesVATS
Interventions
PROCEDURE

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."

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."

Trial Locations (1)

V3V 0C6

Surrey Thoracic Surgery Group, Surrey

Sponsors
All Listed Sponsors
collaborator

Johnson and Johnson Medical

UNKNOWN

lead

Surrey Thoracic Surgery Group

OTHER