Use of Harmonic Scalpel to Decrease Lymphatic and Chest Tube Drainage After Lymph Node Dissection With Lobectomy.

Study Overview
=================
Brief Summary
-----------------
In an effort to elucidate whether the Harmonic Scalpel will improve sealing lymphatics and decrease lymphatic drainage thereby decreasing the length of time that chest tubes are required and minimizing length of stay; the Harmonic Scalpel will be compared to a control group which uses electrocautery. This study will assess these two different methods to determine if there is a notable decrease in the amount of drainage with one versus the other.

Detailed Description
-----------------
Lymph node dissection is an integral part of the surgical management of lung cancer. Knowledge of lymph node status plays a key role in therapeutic decision making and prognosis. Associated with this dissection comes the propensity for lymphatic leakage, increased chest tube drainage, prolonged retention of chest tubes in the postoperative period and increased patient length of stay. Our center performs complete mediastinal node dissection of all relevant regional lymph nodes which generally include paratracheal, pretracheal, subcarinal, hilar and paraesophageal nodes. The current standard of practice for the dissection of the lymph nodes includes the use of the Harmonic Scalpel or electrocautery. Known risk of electrocautery include localized nerve damage, cardiac arrhythmias and damage to the tissue sample/specimen that is used for pathology. The Harmonic Scalpel technology has recently become available for use. Current experience with the Harmonic Scalpel suggests that there is less localized nerve damage, less incidence of arrhythmias, less damage to the tissue sample and less lymph leakage. There is no published data to support this hypothesis, thus the purpose of this study.

Official Title
-----------------
Use of Harmonic Scalpel to Decrease Lymphatic and Chest Tube Drainage After Lymph Node Dissection With Lobectomy. A Single Center Prospective Randomized Controlled Study.

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Device: Harmonic ACE23P Scalpel
* Device: Electrocautery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing resection for stage 1, 2 or 3A lung cancer. Patients between the ages of 20-75. Exclusion Criteria: History of Congestive Heart Failure. History of renal failure, ie., creatinine greater than 2.2. Patients with bulky or matted lymph nodes in stage 3A. Current pregnancy. Current participation in another study involving an investigational device or drug.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Electrocautery used for dissection. | Device: Electrocautery<br> <br> |
| Active Comparator: Group B<br>Harmonic Scalpel used for dissection | Device: Harmonic ACE23P Scalpel<br>* Lymph node dissection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of chest tube drainage |  | daily | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pleural effusions monitored by chest x-ray. |  | Every other day and at four weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung cancer, Lymph node dissection