ENDO GIA Stapler With Duet Tissue Reinforcement System (TRS) Used in Pulmonary Resections

NCT ID: NCT01241617

Last Updated: 2012-01-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2012-01-31

Brief Summary

The objective of this study is to confirm superiority between a test treatment group using Endo GIA stapler with Duet Tissue Reinforcement System (TRS) and a current international standard of care group using a conventional stapler in patients undergoing pulmonary lobectomy surgery, using a randomized comparative study of the frequency of intraoperative air leak.

Detailed Description

Air leak is a complication of pulmonary surgical procedures that include pulmonary lobectomy, segmentectomy, and bullectomy, reported to occur in 33% to 75% of cases.

Prolonged air leak continuing for more than 7 days is reported to have a prevalence of greater than 15%. The presence of a history of smoking, preoperative steroid use, emphysema, low pulmonary function, pleural adhesion, and apical lung wedge resection are shown to be risk factors for prolonged air leak which lengthens the duration of drain placement, increases the days of hospitalization, and reduces patient ADL and QOL. Prolonged air leak may also result in serious complications, such as empyema.

Tissue reinforcement materials widely used as a pleural reinforcement to prevent air leaks during lung surgery, and are reported as a safe and effective material for body tissue reinforcement. Covidien Japan Inc. has developed a surgical stapler (Endo GIA Duet TRS) with an attached reinforcement material. This study will investigate the reinforcement effect on the staple line of using the newly developed surgical stapler with an attached reinforcement material.

Conditions

Lung Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Duet TRS

Endo GIA with integrated Duet TRS

Group Type: ACTIVE_COMPARATOR

Duet TRS

Intervention Type: DEVICE

Endo GIA stapler with integrated Duet TRS

Endo GIA

Endo GIA stapler with Single Use Loading units

Group Type: ACTIVE_COMPARATOR

Endo GIA

Intervention Type: DEVICE

Endo GIA stapler with Single Use Loading Units

Interventions

Duet TRS

Endo GIA stapler with integrated Duet TRS

Intervention Type: DEVICE

Endo GIA

Endo GIA stapler with Single Use Loading Units

Intervention Type: DEVICE

Other Intervention Names

Endo GIA stapler with integrated Duet TRS; Endo GIA stapler with Single Use Loading Units

Eligibility Criteria

Inclusion Criteria

• The patient is between 20-79 years of age.
• The patient is eligible to be given pulmonary Lobectomy.
• The patient is scheduled to undergo pulmonary Lobectomy.
• Performance status 0~1 (Eastern Cooperative Oncology Group classification).
• The patient has no history of lung surgery.
• The patient is healthy organ function.
• The patient is scheduled for surgery with staplers .
• The patient must be willing and able to participate in the study procedures and able to understand and sign the informed consent.

Exclusion Criteria

• The patient has suffered thoracic trauma or has previously undergone pneumonectomy surgery.
• The patient has an active bacterial infection or fungal infection.
• The patient is undergoing continuing systemic administration (intravenous or oral) of steroids.
• The patient condition is complicated by uncontrolled diabetes mellitus.
• The patient participation is judged difficult due to study complications related to a psychiatric disorder or psychological symptoms.
• The patient undergoes surgical procedure other than lobectomy during surgery.
• Reinforcement material other than the study materials are applied during surgery.
• The patient judged unsuitable for study participation by the investigator for any other reason.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenji Suzuki, MD

Role: PRINCIPAL_INVESTIGATOR

Juntendo University

Locations

Junendo University School of Medicine

Tokyo, , Japan

Countries

Japan

Other Identifiers

Juntendo-530

Identifier Type: -

Identifier Source: org_study_id