Clinical trial NCT01241617: 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
Overall status: TERMINATED
Phase: NA
Conditions: Lung Disease
Keywords: Lung disease
Lobectomy
Pulmonary resection
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2010-11-16
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Frequency of intraoperative air leak
timeFrame: Day 0
Secondary outcomes:
measure: Postoperative duration of air leak
timeFrame: Month 1 (Average time period)
measure: Duration of chest drainage
timeFrame: Month 1 (Average time period)
measure: Frequency of intraoperative sealant use
timeFrame: Day 0
measure: Incidence of intraoperative adverse events
timeFrame: Day 0
measure: Incidence of postoperative adverse events
timeFrame: Month 1 (Average time period)
measure: Days of hospitalization
timeFrame: Month 1 (Average time period)
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Junendo University School of Medicine
Study officials:
affiliation: Juntendo University
name: Kenji Suzuki, MD
role: PRINCIPAL_INVESTIGATOR
References: