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

Not Applicable

Terminated

• Conditions: Lung Disease
• Interventions: Device: Duet TRS; Device: Endo GIA

• Registration Number: NCT01241617
• Lead Sponsor: Medtronic - MITG

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.

Study Timeline

• Study First Submitted: 2010-07-30
• Study Start: 2010-08
• Study First Submitted QC: 2010-11-15
• Study First Posted: 2010-11-16
• Status Verified: 2012-01
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Last Update Submitted: 2012-01-22
• Last Update Posted: 2012-01-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Duet TRS	Duet TRS	Endo GIA with integrated Duet TRS
Endo GIA	Endo GIA	Endo GIA stapler with Single Use Loading units

Primary Outcome Measures

Name	Time	Method
Frequency of intraoperative air leak	Day 0	Occurence of intraoperative air leak will vary from patient to patient and will be recorded for all patients.

Secondary Outcome Measures

Name	Time	Method
Postoperative duration of air leak	Month 1 (Average time period)	Duration of air leak will vary from patient to patient. Published literature states a duration of greater than 7 days occurs in 15% of patients.
Duration of chest drainage	Month 1 (Average time period)	Duration of chest drainage will vary from patient to patient.
Frequency of intraoperative sealant use	Day 0	The need to use a sealant intraoperatively will be assessed for each patient during surgery.
Incidence of intraoperative adverse events	Day 0	The occurence of adverse events during surgery will be recorded for each patient.
Incidence of postoperative adverse events	Month 1 (Average time period)	Patients are not required to return to the clinic at a specific time point. Any adverse events that occur after discharge will be captured.
Days of hospitalization	Month 1 (Average time period)	Discharge date will vary from patient to patient

Trial Locations

Locations (1)

Junendo University School of Medicine; 🇯🇵 Tokyo, Japan