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

Medtronic - MITG100 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Lung Disease

Interventions

Duet TRSDEVICE

Endo GIA stapler with integrated Duet TRS

Endo GIADEVICE

Endo GIA stapler with Single Use Loading Units

Eligibility

Sex: ALLMin age: 20 YearsMax age: 79 Years

Medical Language ↔ Plain English

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.

Locations (1)

Junendo University School of Medicine

Tokyo, Japan

Outcomes

Primary Outcomes

Frequency of intraoperative air leak

Occurence of intraoperative air leak will vary from patient to patient and will be recorded for all patients.

Time frame: Day 0

Secondary Outcomes

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.

Time frame: Month 1 (Average time period)

Duration of chest drainage

Duration of chest drainage will vary from patient to patient.

Time frame: 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.

Time frame: Day 0

Incidence of intraoperative adverse events

The occurence of adverse events during surgery will be recorded for each patient.

Time frame: 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.

Time frame: Month 1 (Average time period)

Days of hospitalization

Discharge date will vary from patient to patient

Time frame: Month 1 (Average time period)

Data from ClinicalTrials.gov

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