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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01241617
Recruitment Status : Terminated (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)
First Posted : November 16, 2010
Last Update Posted : January 24, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Lung Disease Device: Duet TRS Device: Endo GIA Not Applicable

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  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Trial Between Buttressed and Non Buttressed Stapling in Pulmonary Lobectomy
Study Start Date : August 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Duet TRS
Endo GIA with integrated Duet TRS
Device: Duet TRS
Endo GIA stapler with integrated Duet TRS
Other Name: 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 Name: Endo GIA stapler with Single Use Loading Units

Primary Outcome Measures :
  1. Frequency of intraoperative air leak [ Time Frame: Day 0 ]
    Occurence of intraoperative air leak will vary from patient to patient and will be recorded for all patients.

Secondary Outcome Measures :
  1. Postoperative duration of air leak [ Time Frame: 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.

  2. Duration of chest drainage [ Time Frame: Month 1 (Average time period) ]
    Duration of chest drainage will vary from patient to patient.

  3. Frequency of intraoperative sealant use [ Time Frame: Day 0 ]
    The need to use a sealant intraoperatively will be assessed for each patient during surgery.

  4. Incidence of intraoperative adverse events [ Time Frame: Day 0 ]
    The occurence of adverse events during surgery will be recorded for each patient.

  5. Incidence of postoperative adverse events [ Time Frame: 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.

  6. Days of hospitalization [ Time Frame: Month 1 (Average time period) ]
    Discharge date will vary from patient to patient

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01241617

Junendo University School of Medicine
Tokyo, Japan
Sponsors and Collaborators
Medtronic - MITG
Principal Investigator: Kenji Suzuki, MD Juntendo University School of Medicine

Responsible Party: Medtronic - MITG Identifier: NCT01241617     History of Changes
Other Study ID Numbers: Juntendo-530
First Posted: November 16, 2010    Key Record Dates
Last Update Posted: January 24, 2012
Last Verified: January 2012

Keywords provided by Medtronic - MITG:
Lung disease
Pulmonary resection

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases