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

Randomized Trial Between Buttressed and Non Buttressed Stapling in Pulmonary Lobectomy

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.

Study Overview

• Status: Terminated
• Conditions: Lung Disease
• Intervention / Treatment: Device: Duet TRS; Device: Endo GIA

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Junendo University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Duet TRS; Endo GIA with integrated Duet TRS	Device: Duet TRS; Endo GIA stapler with integrated Duet TRS; Other Names: Endo GIA stapler with integrated Duet TRS
Active Comparator: Endo GIA; Endo GIA stapler with Single Use Loading units	Device: Endo GIA; Endo GIA stapler with Single Use Loading Units; Other Names: Endo GIA stapler with Single Use Loading Units

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of intraoperative air leak	Occurence of intraoperative air leak will vary from patient to patient and will be recorded for all patients.	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative duration of air leak	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.	Month 1 (Average time period)
Duration of chest drainage	Duration of chest drainage will vary from patient to patient.	Month 1 (Average time period)
Frequency of intraoperative sealant use	The need to use a sealant intraoperatively will be assessed for each patient during surgery.	Day 0
Incidence of intraoperative adverse events	The occurence of adverse events during surgery will be recorded for each patient.	Day 0
Incidence of postoperative adverse events	Patients are not required to return to the clinic at a specific time point. Any adverse events that occur after discharge will be captured.	Month 1 (Average time period)
Days of hospitalization	Discharge date will vary from patient to patient	Month 1 (Average time period)

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: Kenji Suzuki, MD, Juntendo University

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: July 30, 2010
• First Submitted That Met QC Criteria: November 15, 2010
• First Posted (Estimate): November 16, 2010

Study Record Updates

• Last Update Posted (Estimate): January 24, 2012
• Last Update Submitted That Met QC Criteria: January 22, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Lung disease; Lobectomy; Pulmonary resection
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: Juntendo-530