Back to resultsENDO GIA Stapler With Duet Tissue Reinforcement System (TRS) Used in Pulmonary Resections
Primary Purpose
Lung Disease
Status
Terminated
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Duet TRS
Endo GIA
Sponsored by
About this trial
This is an interventional treatment trial for Lung Disease focused on measuring Lung disease, Lobectomy, Pulmonary resection
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.
Sites / Locations
- Junendo University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Duet TRS
Endo GIA
Arm Description
Endo GIA with integrated Duet TRS
Endo GIA stapler with Single Use Loading units
Outcomes
Primary Outcome Measures
Frequency of intraoperative air leak
Occurence of intraoperative air leak will vary from patient to patient and will be recorded for all patients.
Secondary Outcome Measures
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.
Duration of chest drainage
Duration of chest drainage will vary from patient to patient.
Frequency of intraoperative sealant use
The need to use a sealant intraoperatively will be assessed for each patient during surgery.
Incidence of intraoperative adverse events
The occurence of adverse events during surgery will be recorded for each patient.
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.
Days of hospitalization
Discharge date will vary from patient to patient
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01241617
Brief Title
ENDO GIA Stapler With Duet Tissue Reinforcement System (TRS) Used in Pulmonary Resections
Official Title
Randomized Trial Between Buttressed and Non Buttressed Stapling in Pulmonary Lobectomy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Terminated
Why Stopped
Covidien is conducting a voluntary recall of DuetTRS™ use in the thoracic cavity. IFU is revised to contraindicate use in adult and pediatric thoracic surgeries
Study Start Date
August 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic - MITG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Disease
Keywords
Lung disease, Lobectomy, Pulmonary resection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Duet TRS
Arm Type
Active Comparator
Arm Description
Endo GIA with integrated Duet TRS
Arm Title
Endo GIA
Arm Type
Active Comparator
Arm Description
Endo GIA stapler with Single Use Loading units
Intervention Type
Device
Intervention Name(s)
Duet TRS
Other Intervention Name(s)
Endo GIA stapler with integrated Duet TRS
Intervention Description
Endo GIA stapler with integrated Duet TRS
Intervention Type
Device
Intervention Name(s)
Endo GIA
Other Intervention Name(s)
Endo GIA stapler with Single Use Loading Units
Intervention Description
Endo GIA stapler with Single Use Loading Units
Primary Outcome Measure Information:
Title
Frequency of intraoperative air leak
Description
Occurence of intraoperative air leak will vary from patient to patient and will be recorded for all patients.
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Postoperative duration of air leak
Description
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.
Time Frame
Month 1 (Average time period)
Title
Duration of chest drainage
Description
Duration of chest drainage will vary from patient to patient.
Time Frame
Month 1 (Average time period)
Title
Frequency of intraoperative sealant use
Description
The need to use a sealant intraoperatively will be assessed for each patient during surgery.
Time Frame
Day 0
Title
Incidence of intraoperative adverse events
Description
The occurence of adverse events during surgery will be recorded for each patient.
Time Frame
Day 0
Title
Incidence of postoperative adverse events
Description
Patients are not required to return to the clinic at a specific time point. Any adverse events that occur after discharge will be captured.
Time Frame
Month 1 (Average time period)
Title
Days of hospitalization
Description
Discharge date will vary from patient to patient
Time Frame
Month 1 (Average time period)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenji Suzuki, MD
Organizational Affiliation
Juntendo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Junendo University School of Medicine
City
Tokyo
Country
Japan
12. IPD Sharing Statement
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ENDO GIA Stapler With Duet Tissue Reinforcement System (TRS) Used in Pulmonary Resections
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