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

Sentara Cardiovascular Research Institute

Status: Enrolling

Conditions: Lung Cancer

Treatments: Device: Electrocautery; Device: Harmonic ACE23P Scalpel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00591552

SCRI-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Group A

Active Comparator group

Description:

Electrocautery used for dissection.

Treatment:

Device: Electrocautery

Group B

Active Comparator group

Description:

Harmonic Scalpel used for dissection

Treatment:

Device: Harmonic ACE23P Scalpel