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

This study has been 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)
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01241617
First received: July 30, 2010
Last updated: January 22, 2012
Last verified: January 2012
  Purpose

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 Intervention
Lung Disease
Device: Duet TRS
Device: Endo GIA

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Trial Between Buttressed and Non Buttressed Stapling in Pulmonary Lobectomy

Further study details as provided by Covidien:

Primary Outcome Measures:
  • Frequency of intraoperative air leak [ Time Frame: Day 0 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Month 1 (Average time period) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Month 1 (Average time period) ] [ Designated as safety issue: No ]
    Duration of chest drainage will vary from patient to patient.

  • Frequency of intraoperative sealant use [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    The need to use a sealant intraoperatively will be assessed for each patient during surgery.

  • Incidence of intraoperative adverse events [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    The occurence of adverse events during surgery will be recorded for each patient.

  • Incidence of postoperative adverse events [ Time Frame: Month 1 (Average time period) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Month 1 (Average time period) ] [ Designated as safety issue: No ]
    Discharge date will vary from patient to patient


Enrollment: 100
Study Start Date: August 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01241617

Locations
Japan
Junendo University School of Medicine
Tokyo, Japan
Sponsors and Collaborators
Covidien
Investigators
Principal Investigator: Kenji Suzuki, MD Juntendo University School of Medicine
  More Information

No publications provided

Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT01241617     History of Changes
Other Study ID Numbers: Juntendo-530
Study First Received: July 30, 2010
Last Updated: January 22, 2012
Health Authority: Japan: Institutional Review Board

Keywords provided by Covidien:
Lung disease
Lobectomy
Pulmonary resection

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 01, 2014