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

Lung Disease Clinical Trial

Official title:

Randomized Trial Between Buttressed and Non Buttressed Stapling in Pulmonary Lobectomy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01241617
• Other study ID #: Juntendo-530
• Status: Terminated
• Phase: N/A
• First received: July 30, 2010
• Last updated: January 22, 2012
• Start date: August 2010
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 79 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Disease
• Lung Diseases

Intervention

Device:
• Duet TRS
Endo GIA stapler with integrated Duet TRS
• Endo GIA
Endo GIA stapler with Single Use Loading Units

Locations

Country	Name	City	State
Japan	Junendo University School of Medicine	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of intraoperative air leak	Occurence of intraoperative air leak will vary from patient to patient and will be recorded for all patients.	Day 0	Yes
Secondary	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.	Month 1 (Average time period)	No
Secondary	Duration of chest drainage	Duration of chest drainage will vary from patient to patient.	Month 1 (Average time period)	No
Secondary	Frequency of intraoperative sealant use	The need to use a sealant intraoperatively will be assessed for each patient during surgery.	Day 0	No
Secondary	Incidence of intraoperative adverse events	The occurence of adverse events during surgery will be recorded for each patient.	Day 0	No
Secondary	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.	Month 1 (Average time period)	No
Secondary	Days of hospitalization	Discharge date will vary from patient to patient	Month 1 (Average time period)	No