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Use of Harmonic Scalpel to Decrease Lymphatic and Chest Tube Drainage After Lymph Node Dissection With Lobectomy.
Conditions
Lung Cancer
Conditions: Keywords
Lung cancer, Lymph node dissection
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Harmonic ACE23P Scalpel
Type: Device
Name: Electrocautery
Type: Device
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 20 Years
Gender: Both
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.
- 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.
Location
Sentara Norfolk General Hospital/Sentara Heart Hospital
Norfolk, Virginia, United States
Status: Recruiting
Contact: Laura Pine, RN, BSN - 757-388-2732 - ljpine@sentara.com
Start Date
December 2007
Completion Date
August 2009
Sponsors
Sentara Cardiovascular Research Institute
Source
Sentara Cardiovascular Research Institute
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page